Systolic Blood Pressure Intervention Trial

NCT01206062 | Completed Results DMC

• 2 other identifiers: SPRINT268200900040C-1-0-1
• Study Type: interventional
• Target: 9,361
• Locations: 1 country
• Sites: 1

Brief Summary

Elevated blood pressure (BP) is an important public health concern. It is highly prevalent, the prevalence may be increasing, and it is a risk factor for several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. The Systolic Blood Pressure Intervention Trial (SPRINT) is a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease (CVD) risk.

Conditions

Hypertension

Keywords

blood pressure; antihypertensive; systolic; diastolic; heart failure; myocardial infarction; stroke; chronic kidney disease; dementia; cognitive decline

Outcome Measures

Primary Outcomes (1)

• Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death

  6 years

Secondary Outcomes (5)

• Number of Participants With All-cause Mortality

  6 years

• Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR

  6 years

• Participants Who Developed End Stage Renal Disease

  6 years

• Number of Patients With All-cause Dementia

  6 years

• Small Vessel Cerebral Ischemic Disease

  4 years

Study Arms (2)

Intensive Control of SBP

EXPERIMENTAL

Participants randomized into the Intensive BP arm will have a goal of SBP \<120 mm Hg. 2-drug therapy initiated in most Intensive participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP \<120 mm Hg; at periodic "milepost" visits: addition of another drug "required" if not at goal.

Drug: Intensive control of SBP

Standard Control of SBP

ACTIVE COMPARATOR

Participants randomized into the Standard arm will have a goal of SBP \<140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP \<130 mm Hg @ 1 visit; \<135 mm Hg @ 2 consecutive visits

Drug: Standard control of SBP

Interventions

Intensive control of SBP DRUG

Participants in the Intensive arm have a goal of SBP \<120 mm Hg. Use of once-daily antihypertensive agents will be encouraged unless alternative frequency is indicated/necessary. One or more medications from the following classes of agents will be provided by the study for use in managing participants in both randomization groups to achieve study goals: Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics Combination products will be available, depending on cost, utility, or donations from pharmaceutical companies.

Also known as: Lower target for SBP, Comparison of standard SBP control to a target of 120 mm Hg

Intensive Control of SBP

Standard control of SBP DRUG

Participants in the Standard BP arm have a goal of SBP \<140 mm Hg. The same medications used in the Intensive BP arm will be used for the Standard BP arm.

Also known as: Control of SBP to a target of 140 mm Hg

Standard Control of SBP

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 50 years old
• Systolic blood pressure of
• mm Hg on 0 or 1 medication
• mm Hg on up to 2 medications
• mm Hg on up to 3 medications
• mm Hg on up to 4 medications
• Risk (one or more of the following)
• Presence of clinical or subclinical cardiovascular disease other than stroke
• CKD, defined as eGFR 20 - 59 ml/min/1.73m2
• A Framingham Risk Score for 10-year CVD risk ≥ 15%
• Age greater than 75 years

You may not qualify if:

• An indication for a specific BP lowering medication that the person is not taking and the person has not been documented to be intolerant of the medication class.
• Known secondary cause of hypertension that causes concern regarding safety of the protocol.
• One minute standing SBP \< 110 mm Hg.
• Proteinuria in the following ranges (based on a measurement within the past 6 months)
• hour urinary protein excretion ≥1 g/day, or
• hour urinary albumin excretion ≥ 600 mg/day, or
• spot urine protein/creatinine ratio ≥ 1 g/g creatinine, or
• spot urine albumin/creatinine ratio ≥ 600 mg/g creatinine, or
• urine dipstick ≥ 2+ protein
• Arm circumference too large or small to allow accurate blood pressure measurement with available devices
• Diabetes mellitus,
• History of stroke (not CE or stenting)
• Diagnosis of polycystic kidney disease
• Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
• eGFR \< 20 ml/min /1.73m2 or end-stage renal disease (ESRD)

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead
• National Institute on Aging (NIA): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (130)

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• SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.

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• de Vries TI, Stam-Slob MC, Peters RJG, van der Graaf Y, Westerink J, Visseren FLJ. Impact of a Patient's Baseline Risk on the Relative Benefit and Harm of a Preventive Treatment Strategy: Applying Trial Results in Clinical Decision Making. J Am Heart Assoc. 2022 Jan 4;11(1):e017605. doi: 10.1161/JAHA.120.017605. Epub 2021 Dec 22.

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• Pareek M, Vaduganathan M, Byrne C, Mikkelsen AD, Kristensen AMD, Biering-Sorensen T, Kragholm KH, Omar M, Olsen MH, Bhatt DL. Intensive blood pressure control in patients with a history of heart failure: the Systolic Blood Pressure Intervention Trial (SPRINT). Eur Heart J Cardiovasc Pharmacother. 2022 May 5;8(3):E12-E14. doi: 10.1093/ehjcvp/pvab085. No abstract available.

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• Upadhya B, Willard JJ, Lovato LC, Rocco MV, Lewis CE, Oparil S, Cushman WC, Bates JT, Bello NA, Aurigemma G, Johnson KC, Rodriguez CJ, Raj DS, Rastogi A, Tamariz L, Wiggers A, Kitzman DW; SPRINT Research Group. Incidence and Outcomes of Acute Heart Failure With Preserved Versus Reduced Ejection Fraction in SPRINT. Circ Heart Fail. 2021 Dec;14(12):e008322. doi: 10.1161/CIRCHEARTFAILURE.121.008322. Epub 2021 Nov 26.

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• Pajewski NM, Elahi FM, Tamura MK, Hinman JD, Nasrallah IM, Ix JH, Miller LM, Launer LJ, Wright CB, Supiano MA, Lerner AJ, Sudduth TL, Killeen AA, Cheung AK, Reboussin DM, Wilcock DM, Williamson JD. Plasma amyloid beta, neurofilament light chain, and total tau in the Systolic Blood Pressure Intervention Trial (SPRINT). Alzheimers Dement. 2022 Aug;18(8):1472-1483. doi: 10.1002/alz.12496. Epub 2021 Nov 17.

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• Byrne C, Pareek M, Vaduganathan M, Biering-Sorensen T, Krogager ML, Kragholm KH, Steensig K, Mortensen MB, Mishra SR, McCullough MJ, Desai NR, Torp-Pedersen C, Olsen MH, Bhatt DL. Serum Potassium and Mortality in High-Risk Patients: SPRINT. Hypertension. 2021 Nov;78(5):1586-1594. doi: 10.1161/HYPERTENSIONAHA.121.17736. Epub 2021 Oct 4.

  PMID: 34601970 DERIVED

• Kurella Tamura M, Gaussoin S, Pajewski NM, Zaharchuk G, Freedman BI, Rapp SR, Auchus AP, Haley WE, Oparil S, Kendrick J, Roumie CL, Beddhu S, Cheung AK, Williamson JD, Detre JA, Dolui S, Bryan RN, Nasrallah IM; SPRINT Research Group. Kidney Disease, Hypertension Treatment, and Cerebral Perfusion and Structure. Am J Kidney Dis. 2022 May;79(5):677-687.e1. doi: 10.1053/j.ajkd.2021.07.024. Epub 2021 Sep 17.

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• Berry JD, Nambi V, Ambrosius WT, Chen H, Killeen AA, Taylor A, Toto RD, Soliman EZ, McEvoy JW, Pandey A, Joshi PH, Blankenberg S, Kitzman DW, Ballantyne CM, de Lemos JA. Associations of High-Sensitivity Troponin and Natriuretic Peptide Levels With Outcomes After Intensive Blood Pressure Lowering: Findings From the SPRINT Randomized Clinical Trial. JAMA Cardiol. 2021 Dec 1;6(12):1397-1405. doi: 10.1001/jamacardio.2021.3187.

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• Cheng Y, Li J, Ren X, Wang D, Yang Y, Miao Y, Sheng CS, Tian J. Visit-to-visit office blood pressure variability combined with Framingham risk score to predict all-cause mortality: A post hoc analysis of the systolic blood pressure intervention trial. J Clin Hypertens (Greenwich). 2021 Aug;23(8):1516-1525. doi: 10.1111/jch.14314. Epub 2021 Jul 3.

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• Alborzi A, Attar A, Sayadi M, Nouri F. The Effects of Intensive Blood Pressure Control on Cardiovascular Outcomes Based on 10-Year ASCVD Risk Score: An Analysis of a Clinical Trial. Cardiol Res Pract. 2021 May 11;2021:6635345. doi: 10.1155/2021/6635345. eCollection 2021.

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• SPRINT Research Group; Lewis CE, Fine LJ, Beddhu S, Cheung AK, Cushman WC, Cutler JA, Evans GW, Johnson KC, Kitzman DW, Oparil S, Rahman M, Reboussin DM, Rocco MV, Sink KM, Snyder JK, Whelton PK, Williamson JD, Wright JT Jr, Ambrosius WT. Final Report of a Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2021 May 20;384(20):1921-1930. doi: 10.1056/NEJMoa1901281.

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• Bellows BK, Zhang Y, Zhang Z, Lloyd-Jones DM, Bress AP, King JB, Kolm P, Cushman WC, Johnson KC, Tamariz L, Oelsner EC, Shea S, Newman AB, Ives DG, Couper D, Moran AE, Weintraub WS. Estimating Systolic Blood Pressure Intervention Trial Participant Posttrial Survival Using Pooled Epidemiologic Cohort Data. J Am Heart Assoc. 2021 May 18;10(10):e020361. doi: 10.1161/JAHA.120.020361. Epub 2021 May 6.

  PMID: 33955229 DERIVED

• Bress AP, Greene T, Derington CG, Shen J, Xu Y, Zhang Y, Ying J, Bellows BK, Cushman WC, Whelton PK, Pajewski NM, Reboussin D, Beddu S, Hess R, Herrick JS, Zhang Z, Kolm P, Yeh RW, Basu S, Weintraub WS, Moran AE; SPRINT Research Group. Patient Selection for Intensive Blood Pressure Management Based on Benefit and Adverse Events. J Am Coll Cardiol. 2021 Apr 27;77(16):1977-1990. doi: 10.1016/j.jacc.2021.02.058.

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• Wang X, Pei J, Zheng K, Hu X. High-density lipoprotein cholesterol levels are associated with major adverse cardiovascular events in male but not female patients with hypertension. Clin Cardiol. 2021 May;44(5):723-730. doi: 10.1002/clc.23606. Epub 2021 Mar 30.

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• Upadhya B, Pajewski NM, Rocco MV, Hundley WG, Aurigemma G, Hamilton CA, Bates JT, He J, Chen J, Chonchol M, Glasser SP, Hung AM, Pisoni R, Punzi H, Supiano MA, Toto R, Taylor A, Kitzman DW; SPRINT Research Group. Effect of Intensive Blood Pressure Control on Aortic Stiffness in the SPRINT-HEART. Hypertension. 2021 May 5;77(5):1571-1580. doi: 10.1161/HYPERTENSIONAHA.120.16676. Epub 2021 Mar 29.

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• Nasrallah IM, Gaussoin SA, Pomponio R, Dolui S, Erus G, Wright CB, Launer LJ, Detre JA, Wolk DA, Davatzikos C, Williamson JD, Pajewski NM, Bryan RN; SPRINT Research Group. Association of Intensive vs Standard Blood Pressure Control With Magnetic Resonance Imaging Biomarkers of Alzheimer Disease: Secondary Analysis of the SPRINT MIND Randomized Trial. JAMA Neurol. 2021 May 1;78(5):568-577. doi: 10.1001/jamaneurol.2021.0178.

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• Vaduganathan M, Pareek M, Kristensen AMD, Biering-Sorensen T, Byrne C, Almarzooq Z, Olesen TB, Olsen MH, Bhatt DL. Prevention of heart failure events with intensive versus standard blood pressure lowering across the spectrum of kidney function and albuminuria: a SPRINT substudy. Eur J Heart Fail. 2021 Mar;23(3):384-392. doi: 10.1002/ejhf.1971. Epub 2020 Aug 20.

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• Shah C, Srinivasan D, Erus G, Schmitt JE, Agarwal A, Cho ME, Lerner AJ, Haley WE, Kurella Tamura M, Davatzikos C, Bryan RN, Fan Y, Nasrallah IM. Changes in brain functional connectivity and cognition related to white matter lesion burden in hypertensive patients from SPRINT. Neuroradiology. 2021 Jun;63(6):913-924. doi: 10.1007/s00234-020-02614-6. Epub 2021 Jan 6.

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• Xu X, Meng X, Oka SI. Long-Term Habitual Vigorous Physical Activity Is Associated With Lower Visit-to-Visit Systolic Blood Pressure Variability: Insights From the SPRINT Trial. Am J Hypertens. 2021 May 22;34(5):463-466. doi: 10.1093/ajh/hpaa198.

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• Rocco MV, Comeau ME, Marion MC, Freedman BI, Hawfield AT, Langefeld CD; SPRINT Research Group*. Effects of Intensive Systolic Blood Pressure Control on All-Cause Hospitalizations. Hypertension. 2020 Dec;76(6):1717-1724. doi: 10.1161/HYPERTENSIONAHA.120.15868. Epub 2020 Oct 26.

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• Rapp SR, Gaussoin SA, Sachs BC, Chelune G, Supiano MA, Lerner AJ, Wadley VG, Wilson VM, Fine LJ, Whittle JC, Auchus AP, Beddhu S, Berlowitz DR, Bress AP, Johnson KC, Krousel-Wood M, Martindale-Adams J, Miller EC, Rifkin DE, Snyder JK, Tamariz L, Wolfgram DF, Cleveland ML, Yang M, Nichols LO, Bryan RN, Reboussin DM, Williamson JD, Pajewski NM; SPRINT Research Group. Effects of intensive versus standard blood pressure control on domain-specific cognitive function: a substudy of the SPRINT randomised controlled trial. Lancet Neurol. 2020 Nov;19(11):899-907. doi: 10.1016/S1474-4422(20)30319-7.

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• Drawz PE, Agarwal A, Dwyer JP, Horwitz E, Lash J, Lenoir K, McWilliams A, Oparil S, Rahbari-Oskoui F, Rahman M, Parkulo MA, Pemu P, Raj DS, Rocco M, Soman S, Thomas G, Tuot DS, Whelton PK, Pajewski NM. Concordance Between Blood Pressure in the Systolic Blood Pressure Intervention Trial and in Routine Clinical Practice. JAMA Intern Med. 2020 Dec 1;180(12):1655-1663. doi: 10.1001/jamainternmed.2020.5028.

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• Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.

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• Frary JMC, Pareek M, Byrne C, Vaduganathan M, Biering-Sorensen T, Rujic D, Kragholm KH, Olesen TB, Olsen MH, Bhatt DL. Intensive blood pressure control appears to be effective and safe in patients with peripheral artery disease: the Systolic Blood Pressure Intervention Trial. Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e38-e40. doi: 10.1093/ehjcvp/pvaa102. No abstract available.

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• Borazjani R, Kojuri J, Abdi-Ardekani A, Izadpanah P, Dehghani P, Sayadi M, Attar A. Pharmacological treatment of high-normal blood pressure (prehypertension) in high-risk patients for primary prevention of cardiovascular events. J Clin Hypertens (Greenwich). 2020 Sep;22(9):1627-1634. doi: 10.1111/jch.13994. Epub 2020 Aug 20.

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• Krogager ML, Pareek M, Kragholm KH, Byrne C, Vaduganathan M, Biering-Sorensen T, Rujic D, Olesen TB, Olsen MH, Bhatt DL. Intensive vs. standard blood pressure control and vascular procedures: insights from the Systolic Blood Pressure Intervention Trial (SPRINT). Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e35-e37. doi: 10.1093/ehjcvp/pvaa093. No abstract available.

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• Parcha V, Patel N, Kalra R, Kim J, Gutierrez OM, Arora G, Arora P. Incidence and Implications of Atrial Fibrillation/Flutter in Hypertension: Insights From the SPRINT Trial. Hypertension. 2020 Jun;75(6):1483-1490. doi: 10.1161/HYPERTENSIONAHA.120.14690. Epub 2020 May 4.

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• Soliman EZ, Rahman AF, Zhang ZM, Rodriguez CJ, Chang TI, Bates JT, Ghazi L, Blackshear JL, Chonchol M, Fine LJ, Ambrosius WT, Lewis CE. Effect of Intensive Blood Pressure Lowering on the Risk of Atrial Fibrillation. Hypertension. 2020 Jun;75(6):1491-1496. doi: 10.1161/HYPERTENSIONAHA.120.14766. Epub 2020 May 4.

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• Collard D, Brouwer TF, Olde Engberink RHG, Zwinderman AH, Vogt L, van den Born BH. Initial Estimated Glomerular Filtration Rate Decline and Long-Term Renal Function During Intensive Antihypertensive Therapy: A Post Hoc Analysis of the SPRINT and ACCORD-BP Randomized Controlled Trials. Hypertension. 2020 May;75(5):1205-1212. doi: 10.1161/HYPERTENSIONAHA.119.14659. Epub 2020 Mar 30.

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• Dobre M, Pajewski NM, Beddhu S, Chonchol M, Hostetter TH, Li P, Rahman M, Servilla K, Weiner DE, Wright JT, Raphael KL; SPRINT Research Group. Serum bicarbonate and cardiovascular events in hypertensive adults: results from the Systolic Blood Pressure Intervention Trial. Nephrol Dial Transplant. 2020 Aug 1;35(8):1377-1384. doi: 10.1093/ndt/gfz149.

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• Vaduganathan M, Claggett BL, Juraschek SP, Solomon SD. Assessment of Long-term Benefit of Intensive Blood Pressure Control on Residual Life Span: Secondary Analysis of the Systolic Blood Pressure Intervention Trial (SPRINT). JAMA Cardiol. 2020 May 1;5(5):576-581. doi: 10.1001/jamacardio.2019.6192.

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• Juraschek SP, Taylor AA, Wright JT Jr, Evans GW, Miller ER 3rd, Plante TB, Cushman WC, Gure TR, Haley WE, Moinuddin I, Nord J, Oparil S, Pedley C, Roumie CL, Whittle J, Wiggers A, Finucane C, Anne Kenny R, Appel LJ, Townsend RR; SPRINT Research Group. Orthostatic Hypotension, Cardiovascular Outcomes, and Adverse Events: Results From SPRINT. Hypertension. 2020 Mar;75(3):660-667. doi: 10.1161/HYPERTENSIONAHA.119.14309. Epub 2020 Jan 27.

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• Roumie CL, Hung AM, Russell GB, Basile J, Kreider KE, Nord J, Ramsey TM, Rastogi A, Sweeney ME, Tamariz L, Kostis WJ, Williams JS, Zias A, Cushman WC; SPRINT Research Group. Blood Pressure Control and the Association With Diabetes Mellitus Incidence: Results From SPRINT Randomized Trial. Hypertension. 2020 Feb;75(2):331-338. doi: 10.1161/HYPERTENSIONAHA.118.12572. Epub 2019 Dec 23.

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• Pajewski NM, Berlowitz DR, Bress AP, Callahan KE, Cheung AK, Fine LJ, Gaussoin SA, Johnson KC, King J, Kitzman DW, Kostis JB, Lerner AJ, Lewis CE, Oparil S, Rahman M, Reboussin DM, Rocco MV, Snyder JK, Still C, Supiano MA, Wadley VG, Whelton PK, Wright JT Jr,, Williamson JD. Intensive vs Standard Blood Pressure Control in Adults 80 Years or Older: A Secondary Analysis of the Systolic Blood Pressure Intervention Trial. J Am Geriatr Soc. 2020 Mar;68(3):496-504. doi: 10.1111/jgs.16272. Epub 2019 Dec 16.

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• Upadhya B, Lovato LC, Rocco M, Lewis CE, Oparil S, Cushman WC, Kostis JB, Rodriguez CJ, Cho ME, Cloud LW, Rastogi A, Rosendorff C, Kitzman DW; SPRINT Research Group. Heart Failure Prevention in Older Patients Using Intensive Blood Pressure Reduction: Potential Role of Diuretics. JACC Heart Fail. 2019 Dec;7(12):1032-1041. doi: 10.1016/j.jchf.2019.08.018.

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• Berlowitz DR, Foy C, Conroy M, Evans GW, Olney CM, Pisoni R, Powell JR, Gure TR, Shorr RI. Impact of Intensive Blood Pressure Therapy on Concern about Falling: Longitudinal Results from the Systolic Blood Pressure Intervention Trial (SPRINT). J Am Geriatr Soc. 2020 Mar;68(3):614-618. doi: 10.1111/jgs.16264. Epub 2019 Nov 28.

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• Lee CL, Wang JS. Systolic blood pressure trajectory and cardiovascular outcomes: An analysis using data in the Systolic Blood Pressure Intervention Trial. Int J Clin Pract. 2020 Mar;74(3):e13450. doi: 10.1111/ijcp.13450. Epub 2019 Dec 6.

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• Leitao L, Soares-Dos-Reis R, Neves JS, Baptista RB, Bigotte Vieira M, Mc Causland FR. Intensive Blood Pressure Treatment Reduced Stroke Risk in Patients With Albuminuria in the SPRINT Trial. Stroke. 2019 Dec;50(12):3639-3642. doi: 10.1161/STROKEAHA.119.026316. Epub 2019 Oct 22.

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• Sundstrom J, Karmali KN. The case for absolute cardiovascular risk-based blood pressure-lowering treatment decisions: data from the SPRINT trial. J Hum Hypertens. 2020 Jul;34(7):544-545. doi: 10.1038/s41371-019-0260-5. Epub 2019 Sep 23. No abstract available.

  PMID: 31548621 DERIVED

• Byrne C, Pareek M, Vaduganathan M, Biering-Sorensen T, Qamar A, Pandey A, Olesen TB, Olsen MH, Bhatt DL. Intensive blood pressure lowering in different age categories: insights from the Systolic Blood Pressure Intervention Trial. Eur Heart J Cardiovasc Pharmacother. 2020 Nov 1;6(6):356-363. doi: 10.1093/ehjcvp/pvz050.

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• SPRINT MIND Investigators for the SPRINT Research Group; Nasrallah IM, Pajewski NM, Auchus AP, Chelune G, Cheung AK, Cleveland ML, Coker LH, Crowe MG, Cushman WC, Cutler JA, Davatzikos C, Desiderio L, Doshi J, Erus G, Fine LJ, Gaussoin SA, Harris D, Johnson KC, Kimmel PL, Kurella Tamura M, Launer LJ, Lerner AJ, Lewis CE, Martindale-Adams J, Moy CS, Nichols LO, Oparil S, Ogrocki PK, Rahman M, Rapp SR, Reboussin DM, Rocco MV, Sachs BC, Sink KM, Still CH, Supiano MA, Snyder JK, Wadley VG, Walker J, Weiner DE, Whelton PK, Wilson VM, Woolard N, Wright JT Jr, Wright CB, Williamson JD, Bryan RN. Association of Intensive vs Standard Blood Pressure Control With Cerebral White Matter Lesions. JAMA. 2019 Aug 13;322(6):524-534. doi: 10.1001/jama.2019.10551.

  PMID: 31408137 DERIVED

• Lee AK, Katz R, Jotwani V, Garimella PS, Ambrosius WT, Cheung AK, Gren LH, Neyra JA, Punzi H, Raphael KL, Shlipak MG, Ix JH. Distinct Dimensions of Kidney Health and Risk of Cardiovascular Disease, Heart Failure, and Mortality. Hypertension. 2019 Oct;74(4):872-879. doi: 10.1161/HYPERTENSIONAHA.119.13339. Epub 2019 Aug 5.

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• Rathi N, Whelton PK, Chertow GM, Cushman WC, Cheung AK, Wei G, Boucher R, Kimmel PL, Bress AP, Kramer HJ, Al-Marji C, Greene T, Beddhu S. Influence of Prediabetes on the Effects of Intensive Systolic Blood Pressure Control on Kidney Events. Am J Hypertens. 2019 Nov 15;32(12):1170-1177. doi: 10.1093/ajh/hpz105.

  PMID: 31257407 DERIVED

• Derington CG, Gums TH, Bress AP, Herrick JS, Greene TH, Moran AE, Weintraub WS, Kronish IM, Morisky DE, Trinkley KE, Saseen JJ, Reynolds K, Bates JT, Berlowitz DR, Chang TI, Chonchol M, Cushman WC, Foy CG, Herring CT, Katz LA, Krousel-Wood M, Pajewski NM, Tamariz L, King JB; SPRINT Research Group. Association of Total Medication Burden With Intensive and Standard Blood Pressure Control and Clinical Outcomes: A Secondary Analysis of SPRINT. Hypertension. 2019 Aug;74(2):267-275. doi: 10.1161/HYPERTENSIONAHA.119.12907. Epub 2019 Jul 1.

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• Smith SM, Gurka MJ, Winterstein AG, Pepine CJ, Cooper-DeHoff RM. Incidence, prevalence, and predictors of treatment-resistant hypertension with intensive blood pressure lowering. J Clin Hypertens (Greenwich). 2019 Jun;21(6):825-834. doi: 10.1111/jch.13550. Epub 2019 May 7.

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• Duan T, Rajpurkar P, Laird D, Ng AY, Basu S. Clinical Value of Predicting Individual Treatment Effects for Intensive Blood Pressure Therapy. Circ Cardiovasc Qual Outcomes. 2019 Mar;12(3):e005010. doi: 10.1161/CIRCOUTCOMES.118.005010.

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• Sobieraj P, Lewandowski J, Sinski M, Symonides B, Gaciong Z. Low Diastolic Blood Pressure is Not Related to Risk of First Episode of Stroke in a High-Risk Population: A Secondary Analysis of SPRINT. J Am Heart Assoc. 2019 Feb 19;8(4):e010811. doi: 10.1161/JAHA.118.010811.

  PMID: 30744452 DERIVED

• SPRINT MIND Investigators for the SPRINT Research Group; Williamson JD, Pajewski NM, Auchus AP, Bryan RN, Chelune G, Cheung AK, Cleveland ML, Coker LH, Crowe MG, Cushman WC, Cutler JA, Davatzikos C, Desiderio L, Erus G, Fine LJ, Gaussoin SA, Harris D, Hsieh MK, Johnson KC, Kimmel PL, Tamura MK, Launer LJ, Lerner AJ, Lewis CE, Martindale-Adams J, Moy CS, Nasrallah IM, Nichols LO, Oparil S, Ogrocki PK, Rahman M, Rapp SR, Reboussin DM, Rocco MV, Sachs BC, Sink KM, Still CH, Supiano MA, Snyder JK, Wadley VG, Walker J, Weiner DE, Whelton PK, Wilson VM, Woolard N, Wright JT Jr, Wright CB. Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia: A Randomized Clinical Trial. JAMA. 2019 Feb 12;321(6):553-561. doi: 10.1001/jama.2018.21442.

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• Rueda-Ochoa OL, Rojas LZ, Ahmad S, van Duijn CM, Ikram MA, Deckers JW, Franco OH, Rizopoulos D, Kavousi M. Impact of cumulative SBP and serious adverse events on efficacy of intensive blood pressure treatment: a randomized clinical trial. J Hypertens. 2019 May;37(5):1058-1069. doi: 10.1097/HJH.0000000000002001.

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• Supiano MA, Lovato L, Ambrosius WT, Bates J, Beddhu S, Drawz P, Dwyer JP, Hamburg NM, Kitzman D, Lash J, Lustigova E, Miracle CM, Oparil S, Raj DS, Weiner DE, Taylor A, Vita JA, Yunis R, Chertow GM, Chonchol M. Pulse wave velocity and central aortic pressure in systolic blood pressure intervention trial participants. PLoS One. 2018 Sep 26;13(9):e0203305. doi: 10.1371/journal.pone.0203305. eCollection 2018.

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• Beddhu S, Greene T, Boucher R, Cushman WC, Wei G, Stoddard G, Ix JH, Chonchol M, Kramer H, Cheung AK, Kimmel PL, Whelton PK, Chertow GM. Intensive systolic blood pressure control and incident chronic kidney disease in people with and without diabetes mellitus: secondary analyses of two randomised controlled trials. Lancet Diabetes Endocrinol. 2018 Jul;6(7):555-563. doi: 10.1016/S2213-8587(18)30099-8. Epub 2018 Apr 21.

  PMID: 29685860 DERIVED

• Dobre M, Gaussoin SA, Bates JT, Chonchol MB, Cohen DL, Hostetter TH, Raphael KL, Taylor AA, Lerner AJ, Wright JT Jr, Rahman M; SPRINT Research Group. Serum Bicarbonate Concentration and Cognitive Function in Hypertensive Adults. Clin J Am Soc Nephrol. 2018 Apr 6;13(4):596-603. doi: 10.2215/CJN.07050717. Epub 2018 Mar 22.

  PMID: 29567858 DERIVED

• Johnson KC, Whelton PK, Cushman WC, Cutler JA, Evans GW, Snyder JK, Ambrosius WT, Beddhu S, Cheung AK, Fine LJ, Lewis CE, Rahman M, Reboussin DM, Rocco MV, Oparil S, Wright JT Jr; SPRINT Research Group. Blood Pressure Measurement in SPRINT (Systolic Blood Pressure Intervention Trial). Hypertension. 2018 May;71(5):848-857. doi: 10.1161/HYPERTENSIONAHA.117.10479. Epub 2018 Mar 12.

  PMID: 29531173 DERIVED

• Foy CG, Lovato LC, Vitolins MZ, Bates JT, Campbell R, Cushman WC, Glasser SP, Gillespie A, Kostis WJ, Krousel-Wood M, Muhlestein JB, Oparil S, Osei K, Pisoni R, Segal MS, Wiggers A, Johnson KC; SPRINT Study Research Group. Gender, blood pressure, and cardiovascular and renal outcomes in adults with hypertension from the Systolic Blood Pressure Intervention Trial. J Hypertens. 2018 Apr;36(4):904-915. doi: 10.1097/HJH.0000000000001619.

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• Vaduganathan M, Pareek M, Qamar A, Pandey A, Olsen MH, Bhatt DL. Baseline Blood Pressure, the 2017 ACC/AHA High Blood Pressure Guidelines, and Long-Term Cardiovascular Risk in SPRINT. Am J Med. 2018 Aug;131(8):956-960. doi: 10.1016/j.amjmed.2017.12.049. Epub 2018 Feb 5.

  PMID: 29421687 DERIVED

• Juraschek SP, Miller ER 3rd, Appel LJ. Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens. 2018 May 7;31(6):665-671. doi: 10.1093/ajh/hpy010.

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• Brouwer TF, Vehmeijer JT, Kalkman DN, Berger WR, van den Born BH, Peters RJ, Knops RE. Intensive Blood Pressure Lowering in Patients With and Patients Without Type 2 Diabetes: A Pooled Analysis From Two Randomized Trials. Diabetes Care. 2018 Jun;41(6):1142-1148. doi: 10.2337/dc17-1722. Epub 2017 Dec 6.

  PMID: 29212825 DERIVED

• Rocco MV, Sink KM, Lovato LC, Wolfgram DF, Wiegmann TB, Wall BM, Umanath K, Rahbari-Oskoui F, Porter AC, Pisoni R, Lewis CE, Lewis JB, Lash JP, Katz LA, Hawfield AT, Haley WE, Freedman BI, Dwyer JP, Drawz PE, Dobre M, Cheung AK, Campbell RC, Bhatt U, Beddhu S, Kimmel PL, Reboussin DM, Chertow GM; SPRINT Research Group. Effects of Intensive Blood Pressure Treatment on Acute Kidney Injury Events in the Systolic Blood Pressure Intervention Trial (SPRINT). Am J Kidney Dis. 2018 Mar;71(3):352-361. doi: 10.1053/j.ajkd.2017.08.021. Epub 2017 Nov 20.

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• Obi Y, Kalantar-Zadeh K, Shintani A, Kovesdy CP, Hamano T. Estimated glomerular filtration rate and the risk-benefit profile of intensive blood pressure control amongst nondiabetic patients: a post hoc analysis of a randomized clinical trial. J Intern Med. 2018 Mar;283(3):314-327. doi: 10.1111/joim.12701. Epub 2017 Nov 19.

  PMID: 29044764 DERIVED

• Beddhu S, Chertow GM, Cheung AK, Cushman WC, Rahman M, Greene T, Wei G, Campbell RC, Conroy M, Freedman BI, Haley W, Horwitz E, Kitzman D, Lash J, Papademetriou V, Pisoni R, Riessen E, Rosendorff C, Watnick SG, Whittle J, Whelton PK; SPRINT Research Group. Influence of Baseline Diastolic Blood Pressure on Effects of Intensive Compared With Standard Blood Pressure Control. Circulation. 2018 Jan 9;137(2):134-143. doi: 10.1161/CIRCULATIONAHA.117.030848. Epub 2017 Oct 11.

  PMID: 29021322 DERIVED

• Still CH, Rodriguez CJ, Wright JT Jr, Craven TE, Bress AP, Chertow GM, Whelton PK, Whittle JC, Freedman BI, Johnson KC, Foy CG, He J, Kostis JB, Lash JP, Pedley CF, Pisoni R, Powell JR, Wall BM; SPRINT Writing Group. Clinical Outcomes by Race and Ethnicity in the Systolic Blood Pressure Intervention Trial (SPRINT): A Randomized Clinical Trial. Am J Hypertens. 2017 Dec 8;31(1):97-107. doi: 10.1093/ajh/hpx138.

  PMID: 28985268 DERIVED

• Kalkman DN, Brouwer TF, Vehmeijer JT, Berger WR, Knops RE, de Winter RJ, Peters RJ, van den Born BH. J Curve in Patients Randomly Assigned to Different Systolic Blood Pressure Targets: An Experimental Approach to an Observational Paradigm. Circulation. 2017 Dec 5;136(23):2220-2229. doi: 10.1161/CIRCULATIONAHA.117.030342. Epub 2017 Sep 22.

  PMID: 28939617 DERIVED

• Beddhu S, Rocco MV, Toto R, Craven TE, Greene T, Bhatt U, Cheung AK, Cohen D, Freedman BI, Hawfield AT, Killeen AA, Kimmel PL, Lash J, Papademetriou V, Rahman M, Rastogi A, Servilla K, Townsend RR, Wall B, Whelton PK; SPRINT Research Group. Effects of Intensive Systolic Blood Pressure Control on Kidney and Cardiovascular Outcomes in Persons Without Kidney Disease: A Secondary Analysis of a Randomized Trial. Ann Intern Med. 2017 Sep 19;167(6):375-383. doi: 10.7326/M16-2966. Epub 2017 Sep 5.

  PMID: 28869987 DERIVED

• Berlowitz DR, Foy CG, Kazis LE, Bolin LP, Conroy MB, Fitzpatrick P, Gure TR, Kimmel PL, Kirchner K, Morisky DE, Newman J, Olney C, Oparil S, Pajewski NM, Powell J, Ramsey T, Simmons DL, Snyder J, Supiano MA, Weiner DE, Whittle J; SPRINT Research Group. Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes. N Engl J Med. 2017 Aug 24;377(8):733-744. doi: 10.1056/NEJMoa1611179.

  PMID: 28834483 DERIVED

• Bress AP, Bellows BK, King JB, Hess R, Beddhu S, Zhang Z, Berlowitz DR, Conroy MB, Fine L, Oparil S, Morisky DE, Kazis LE, Ruiz-Negron N, Powell J, Tamariz L, Whittle J, Wright JT Jr, Supiano MA, Cheung AK, Weintraub WS, Moran AE; SPRINT Research Group. Cost-Effectiveness of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2017 Aug 24;377(8):745-755. doi: 10.1056/NEJMsa1616035.

  PMID: 28834469 DERIVED

• Chang TI, Reboussin DM, Chertow GM, Cheung AK, Cushman WC, Kostis WJ, Parati G, Raj D, Riessen E, Shapiro B, Stergiou GS, Townsend RR, Tsioufis K, Whelton PK, Whittle J, Wright JT, Papademetriou V; SPRINT Research Group*. Visit-to-Visit Office Blood Pressure Variability and Cardiovascular Outcomes in SPRINT (Systolic Blood Pressure Intervention Trial). Hypertension. 2017 Oct;70(4):751-758. doi: 10.1161/HYPERTENSIONAHA.117.09788. Epub 2017 Jul 31.

  PMID: 28760939 DERIVED

• Soliman EZ, Ambrosius WT, Cushman WC, Zhang ZM, Bates JT, Neyra JA, Carson TY, Tamariz L, Ghazi L, Cho ME, Shapiro BP, He J, Fine LJ, Lewis CE; SPRINT Research Study Group. Effect of Intensive Blood Pressure Lowering on Left Ventricular Hypertrophy in Patients With Hypertension: SPRINT (Systolic Blood Pressure Intervention Trial). Circulation. 2017 Aug 1;136(5):440-450. doi: 10.1161/CIRCULATIONAHA.117.028441. Epub 2017 May 16.

  PMID: 28512184 DERIVED

• Patel KK, Arnold SV, Chan PS, Tang Y, Pokharel Y, Jones PG, Spertus JA. Personalizing the Intensity of Blood Pressure Control: Modeling the Heterogeneity of Risks and Benefits From SPRINT (Systolic Blood Pressure Intervention Trial). Circ Cardiovasc Qual Outcomes. 2017 Apr;10(4):e003624. doi: 10.1161/CIRCOUTCOMES.117.003624.

  PMID: 28373269 DERIVED

• Upadhya B, Rocco M, Lewis CE, Oparil S, Lovato LC, Cushman WC, Bates JT, Bello NA, Aurigemma G, Fine LJ, Johnson KC, Rodriguez CJ, Raj DS, Rastogi A, Tamariz L, Wiggers A, Kitzman DW; SPRINT Research Group. Effect of Intensive Blood Pressure Treatment on Heart Failure Events in the Systolic Blood Pressure Reduction Intervention Trial. Circ Heart Fail. 2017 Apr;10(4):e003613. doi: 10.1161/CIRCHEARTFAILURE.116.003613.

  PMID: 28364091 DERIVED

• Odden MC, Peralta CA, Berlowitz DR, Johnson KC, Whittle J, Kitzman DW, Beddhu S, Nord JW, Papademetriou V, Williamson JD, Pajewski NM; Systolic Blood Pressure Intervention Trial (SPRINT) Research Group. Effect of Intensive Blood Pressure Control on Gait Speed and Mobility Limitation in Adults 75 Years or Older: A Randomized Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):500-507. doi: 10.1001/jamainternmed.2016.9104.

  PMID: 28166324 DERIVED

• Supiano MA, Williamson JD. Applying the Systolic Blood Pressure Intervention Trial Results to Older Adults. J Am Geriatr Soc. 2017 Jan;65(1):16-21. doi: 10.1111/jgs.14681. Epub 2016 Nov 7.

  PMID: 28111758 DERIVED

• Foy CG, Newman JC, Berlowitz DR, Russell LP, Kimmel PL, Wadley VG, Thomas HN, Lerner AJ, Riley WT; SPRINT Study Research Group. Blood Pressure, Sexual Activity, and Dysfunction in Women With Hypertension: Baseline Findings From the Systolic Blood Pressure Intervention Trial (SPRINT). J Sex Med. 2016 Sep;13(9):1333-1346. doi: 10.1016/j.jsxm.2016.06.014.

  PMID: 27555505 DERIVED

• Rocco MV, Chapman A, Chertow GM, Cohen D, Chen J, Cutler JA, Diamond MJ, Freedman BI, Hawfield A, Judd E, Killeen AA, Kirchner K, Lewis CE, Pajewski NM, Wall BM, Yee J; SPRINT Research Group. Chronic Kidney Disease Classification in Systolic Blood Pressure Intervention Trial: Comparison Using Modification of Diet in Renal Disease and CKD-Epidemiology Collaboration Definitions. Am J Nephrol. 2016;44(2):130-40. doi: 10.1159/000448722. Epub 2016 Aug 12.

  PMID: 27513312 DERIVED

• Williamson JD, Supiano MA, Applegate WB, Berlowitz DR, Campbell RC, Chertow GM, Fine LJ, Haley WE, Hawfield AT, Ix JH, Kitzman DW, Kostis JB, Krousel-Wood MA, Launer LJ, Oparil S, Rodriguez CJ, Roumie CL, Shorr RI, Sink KM, Wadley VG, Whelton PK, Whittle J, Woolard NF, Wright JT Jr, Pajewski NM; SPRINT Research Group. Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged >/=75 Years: A Randomized Clinical Trial. JAMA. 2016 Jun 28;315(24):2673-82. doi: 10.1001/jama.2016.7050.

  PMID: 27195814 DERIVED

• Thomas HN, Evans GW, Berlowitz DR, Chertow GM, Conroy MB, Foy CG, Glasser SP, Lewis CE, Riley WT, Russell L, Williams O, Hess R; SPRINT Study Group. Antihypertensive medications and sexual function in women: baseline data from the SBP intervention trial (SPRINT). J Hypertens. 2016 Jun;34(6):1224-31. doi: 10.1097/HJH.0000000000000911.

  PMID: 27032074 DERIVED

• Tamura MK, Pajewski NM, Bryan RN, Weiner DE, Diamond M, Van Buren P, Taylor A, Beddhu S, Rosendorff C, Jahanian H, Zaharchuk G; SPRINT Study Research Group. Chronic kidney disease, cerebral blood flow, and white matter volume in hypertensive adults. Neurology. 2016 Mar 29;86(13):1208-16. doi: 10.1212/WNL.0000000000002527. Epub 2016 Feb 26.

  PMID: 26920359 DERIVED

• Chang TI, Evans G, Cheung AK, Cushman WC, Diamond MJ, Dwyer JP, Huan Y, Kitzman D, Kostis JB, Oparil S, Rastogi A, Roumie CL, Sahay R, Stafford RS, Taylor AA, Wright JT Jr, Chertow GM; SPRINT Study Research Group. Patterns and Correlates of Baseline Thiazide-Type Diuretic Prescription in the Systolic Blood Pressure Intervention Trial. Hypertension. 2016 Mar;67(3):550-5. doi: 10.1161/HYPERTENSIONAHA.115.06851. Epub 2016 Jan 25.

  PMID: 26865200 DERIVED

• Cushman WC, Whelton PK, Fine LJ, Wright JT Jr, Reboussin DM, Johnson KC, Oparil S; SPRINT Study Research Group. SPRINT Trial Results: Latest News in Hypertension Management. Hypertension. 2016 Feb;67(2):263-5. doi: 10.1161/HYPERTENSIONAHA.115.06722. Epub 2015 Nov 9. No abstract available.

  PMID: 26553234 DERIVED

• Verdecchia P, Angeli F, Reboldi G. The SPRINT trial. J Am Soc Hypertens. 2015 Oct;9(10):750-753. doi: 10.1016/j.jash.2015.09.001. Epub 2015 Sep 9. No abstract available.

  PMID: 26506129 DERIVED

MeSH Terms

Conditions

Hypertension; Systolic Murmurs; Heart Murmurs; Heart Failure; Myocardial Infarction; Stroke; Renal Insufficiency, Chronic; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Myocardial Ischemia; Infarction; Ischemia; Pathologic Processes; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: David Reboussin
• Organization: Wake Forest University Health Sciences

drebouss@wakehealth.edu

336-716-6844

Study Officials

• David M. Reboussin, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Jackson T Wright, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Alfred Cheung, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Suzanne Oparil, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Mike Rocco, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Bill Cushman, MD

  Memphis VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Coordinating Center

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 21, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: March 1, 2019
• Last Updated: January 8, 2021
• Results First Posted: December 4, 2017

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)