Home Blood Pressure (HBP)-Guided Management of Hypertension in Stage 3-4 CKD

NCT03588520 | Unknown

• 1 other identifier: 4475
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

It is estimated that over 25% of the world's population had hypertension in the year 2000 and that this proportion will reach 30% in the year 2025. With the introduction of the 2017 Guideline for High Blood Pressure in Adults from the American College of Cardiology and the American Heart Association Task Force on Clinical Practice Guidelines, the definition of hypertension became broader and as a result the prevalence is expected to further increase. On the other hand, it is estimated that around 10% of the world's population is affected by chronic kidney disease (CKD) with hypertension being both cause and complication of CKD. It is obvious that hypertension and CKD are interconnected and are both major risk factors for cardiovascular disease (CVD). Hypertension results in increased CVD risk both directly, as an independent factor, and indirectly via its negative impact on renal function. In fact, the deterioration of the renal function is proportional to the degree of hypertension. On the other hand, the more advanced the CKD is, the more challenging the management of hypertension becomes, as patients with CKD present altered patterns of blood pressure (BP) during the day and, additionally, the prevalence of white coat and masked hypertension is significantly higher in this group of patients. To date, hypertensive patients are treated according to the BP recordings that are obtained in the office (OBP) during routine patient visits, which leads to inaccurate estimates of the true burden of hypertension and also affects the efficacy of the therapeutic intervention. It has been suggested that self measured BP (HBP) is a more accurate estimate of the patients' daytime BP compared to the conventional office BP measurements. This has been already confirmed in studies regarding the general population and it has been suggested that the same applies to the patients with CKD. This study aims to check the validity of this hypothesis by comparing the effect of the HBP - guided management versus the conventional OBP - guided management on the 24 hour ambulatory BP monitoring of patients with uncontrolled hypertension and CKD stage 3 and 4.

Conditions

Hypertension; Chronic Kidney Diseases

Keywords

Hypertension; Chronic Kidney Disease; Home Blood Pressure Monitoring; Blood Pressure Management; Masked Hypertension; White Coat Hypertension; Renal Insufficiency; Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• Ambulatory Blood Pressure Measurement

  The difference in the change from baseline to 4 months in mean 24-hour ambulatory systolic, diastolic and mean BP between the HBP-guided management of hypertension and control groups.

  4 months

Secondary Outcomes (7)

• Office BP measurements

  4 months

• Hypertension Control Rates

  4 months

• Central Aortic BP

  4 months

• Carotid to femoral pulse wave velocity (cfPWV)

  4 months

• Heart rate-corrected augmentation index AIx(75)

  4 months

Other Outcomes (1)

• Secondary safety endpoint

  4 months

Study Arms (2)

Home BP Monitoring Group

EXPERIMENTAL

Patients allocated to this group will receive a home blood pressure monitoring device and decisions to modify the hypertension treatment will be based on the results of the home blood pressure monitoring in accordance with the current guidelines of the European Society for Hypertension for the Treatment of Hypertension.

Diagnostic Test: Home Blood Pressure Monitoring

Office BP Monitoring Group

NO INTERVENTION

Patients allocated to this group will act as controls. They will receive no home blood pressure monitoring device and decisions to modify the hypertension treatment will be based exclusively on blood pressure measurements in office visits.

Interventions

Home Blood Pressure Monitoring DIAGNOSTIC_TEST

Patients randomly assigned to the HBP-guided management group will perform home BP monitoring for 7 days with the use of a validated self-inflating automatic oscillometric device (HEM 705 CP, Omron Healthcare). Home BP monitoring will be performed according to the currently available European Society of Hypertension guidelines at the baseline visit and will be repeated 1 week before the prespecified follow-up visits (at Month 1, Month 2 and Month 4). Patients randomly assigned to the control group will receive conventional management of hypertension based on office BP recordings obtained with the same BP monitor (HEM 705 CP, Omron Healthcare) during the same prespecified follow-up visits.

Home BP Monitoring Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years old or higher
• Stable CKD stage 3-4 (CKD-EPI estimated GFR: 15-60 ml/min/1.73m2)
• Treated or untreated uncontrolled hypertension, defined as office BP \>140/90 mmHg for patients with diabetic or non-diabetic CKD and protein excretion \<0.3 gr/day or office BP \>130/80 mmHg for patients with diabetic or non-diabetic CKD and protein excretion ≥0.3 gr/day.22-24
• Patients must provide informed written consent

You may not qualify if:

• End-stage renal disease under hemodialysis or peritoneal dialysis
• Known secondary cause of hypertension (i.e., pheochromocytoma, primary aldosteronism, renovascular hypertension)
• Chronic atrial fibrillation
• Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
• Severe congestive heart failure stage III-IV according to New York Heart Association (NYHA) classification
• Body mass index (BMI) of \>40 kg/m2
• History of malignancy or any other clinical condition associated with very poor prognosis

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

AHEPA University Hospital of Thessaloniki

Thessaloniki, Makedonia, Greece

RECRUITING

Related Publications (37)

• Sarafidis PA, Li S, Chen SC, Collins AJ, Brown WW, Klag MJ, Bakris GL. Hypertension awareness, treatment, and control in chronic kidney disease. Am J Med. 2008 Apr;121(4):332-40. doi: 10.1016/j.amjmed.2007.11.025.

  PMID: 18374693 BACKGROUND

• Sarafidis PA, Sharpe CC, Wood E, Blacklock R, Rumjon A, Al-Yassin A, Ariyanayagam R, Simmonds S, Fletcher-Rogers J, Vinen K. Prevalence, patterns of treatment, and control of hypertension in predialysis patients with chronic kidney disease. Nephron Clin Pract. 2012;120(3):c147-55. doi: 10.1159/000337571. Epub 2012 Jun 5.

  PMID: 22678150 BACKGROUND

• Agarwal R, Pappas MK, Sinha AD. Masked Uncontrolled Hypertension in CKD. J Am Soc Nephrol. 2016 Mar;27(3):924-32. doi: 10.1681/ASN.2015030243. Epub 2015 Jul 10.

  PMID: 26163421 BACKGROUND

• Cohen DL, Huan Y, Townsend RR. Home blood pressure monitoring in CKD. Am J Kidney Dis. 2014 May;63(5):835-42. doi: 10.1053/j.ajkd.2013.12.015. Epub 2014 Feb 12.

  PMID: 24529535 BACKGROUND

• Gorostidi M, Sarafidis PA, de la Sierra A, Segura J, de la Cruz JJ, Banegas JR, Ruilope LM; Spanish ABPM Registry Investigators. Differences between office and 24-hour blood pressure control in hypertensive patients with CKD: A 5,693-patient cross-sectional analysis from Spain. Am J Kidney Dis. 2013 Aug;62(2):285-94. doi: 10.1053/j.ajkd.2013.03.025. Epub 2013 May 18.

  PMID: 23689071 BACKGROUND

• Bangash F, Agarwal R. Masked hypertension and white-coat hypertension in chronic kidney disease: a meta-analysis. Clin J Am Soc Nephrol. 2009 Mar;4(3):656-64. doi: 10.2215/CJN.05391008. Epub 2009 Mar 4.

  PMID: 19261815 BACKGROUND

• Parati G, Ochoa JE, Bilo G, Agarwal R, Covic A, Dekker FW, Fliser D, Heine GH, Jager KJ, Gargani L, Kanbay M, Mallamaci F, Massy Z, Ortiz A, Picano E, Rossignol P, Sarafidis P, Sicari R, Vanholder R, Wiecek A, London G, Zoccali C; European Renal and Cardiovascular Medicine (EURECA-m) working group of the European Renal Association-European Dialysis Transplantation Association (ERA-EDTA). Hypertension in Chronic Kidney Disease Part 2: Role of Ambulatory and Home Blood Pressure Monitoring for Assessing Alterations in Blood Pressure Variability and Blood Pressure Profiles. Hypertension. 2016 Jun;67(6):1102-10. doi: 10.1161/HYPERTENSIONAHA.115.06896. Epub 2016 May 2. No abstract available.

  PMID: 27141057 BACKGROUND

• Parati G, Ochoa JE, Bilo G, Agarwal R, Covic A, Dekker FW, Fliser D, Heine GH, Jager KJ, Gargani L, Kanbay M, Mallamaci F, Massy Z, Ortiz A, Picano E, Rossignol P, Sarafidis P, Sicari R, Vanholder R, Wiecek A, London G, Zoccali C; European Renal and Cardiovascular Medicine (EURECA-m) working group of the European Renal Association-European Dialysis Transplantation Association (ERA-EDTA). Hypertension in Chronic Kidney Disease Part 1: Out-of-Office Blood Pressure Monitoring: Methods, Thresholds, and Patterns. Hypertension. 2016 Jun;67(6):1093-101. doi: 10.1161/HYPERTENSIONAHA.115.06895. Epub 2016 May 2. No abstract available.

  PMID: 27141058 BACKGROUND

• Agarwal R. Arterial stiffness and its relationship to clinic and ambulatory blood pressure: a longitudinal study in non-dialysis chronic kidney disease. Nephrol Dial Transplant. 2017 Nov 1;32(11):1850-1856. doi: 10.1093/ndt/gfw281.

  PMID: 27474747 BACKGROUND

• Agarwal R. Longitudinal Study of Left Ventricular Mass Growth: Comparative Study of Clinic and Ambulatory Systolic Blood Pressure in Chronic Kidney Disease. Hypertension. 2016 Apr;67(4):710-6. doi: 10.1161/HYPERTENSIONAHA.115.07052. Epub 2016 Feb 1.

  PMID: 26831191 BACKGROUND

• Rave K, Bender R, Heise T, Sawicki PT. Value of blood pressure self-monitoring as a predictor of progression of diabetic nephropathy. J Hypertens. 1999 May;17(5):597-601. doi: 10.1097/00004872-199917050-00002.

  PMID: 10403602 BACKGROUND

• Suzuki H, Nakamoto H, Okada H, Sugahara S, Kanno Y. Self-measured systolic blood pressure in the morning is a strong indicator of decline of renal function in hypertensive patients with non-diabetic chronic renal insufficiency. Clin Exp Hypertens. 2002 May;24(4):249-60. doi: 10.1081/ceh-120004229.

  PMID: 12069356 BACKGROUND

• Agarwal R, Andersen MJ. Blood pressure recordings within and outside the clinic and cardiovascular events in chronic kidney disease. Am J Nephrol. 2006;26(5):503-10. doi: 10.1159/000097366. Epub 2006 Nov 22.

  PMID: 17124383 BACKGROUND

• Minutolo R, Gabbai FB, Agarwal R, Chiodini P, Borrelli S, Bellizzi V, Nappi F, Stanzione G, Conte G, De Nicola L. Assessment of achieved clinic and ambulatory blood pressure recordings and outcomes during treatment in hypertensive patients with CKD: a multicenter prospective cohort study. Am J Kidney Dis. 2014 Nov;64(5):744-52. doi: 10.1053/j.ajkd.2014.06.014. Epub 2014 Jul 28.

  PMID: 25082100 BACKGROUND

• Shimada K, Kario K, Kushiro T, Teramukai S, Zenimura N, Ishikawa Y, Okuda Y, Saito I. Prognostic significance of on-treatment home and clinic blood pressure for predicting cardiovascular events in hypertensive patients in the HONEST study. J Hypertens. 2016 Aug;34(8):1520-7. doi: 10.1097/HJH.0000000000000966.

  PMID: 27310464 BACKGROUND

• Georgianos PI, Agarwal R. Epidemiology, diagnosis and management of hypertension among patients on chronic dialysis. Nat Rev Nephrol. 2016 Oct;12(10):636-47. doi: 10.1038/nrneph.2016.129. Epub 2016 Aug 30.

  PMID: 27573731 BACKGROUND

• Agarwal R, Bills JE, Hecht TJ, Light RP. Role of home blood pressure monitoring in overcoming therapeutic inertia and improving hypertension control: a systematic review and meta-analysis. Hypertension. 2011 Jan;57(1):29-38. doi: 10.1161/HYPERTENSIONAHA.110.160911. Epub 2010 Nov 29.

  PMID: 21115879 BACKGROUND

• Parati G, Stergiou GS, Asmar R, Bilo G, de Leeuw P, Imai Y, Kario K, Lurbe E, Manolis A, Mengden T, O'Brien E, Ohkubo T, Padfield P, Palatini P, Pickering T, Redon J, Revera M, Ruilope LM, Shennan A, Staessen JA, Tisler A, Waeber B, Zanchetti A, Mancia G; ESH Working Group on Blood Pressure Monitoring. European Society of Hypertension guidelines for blood pressure monitoring at home: a summary report of the Second International Consensus Conference on Home Blood Pressure Monitoring. J Hypertens. 2008 Aug;26(8):1505-26. doi: 10.1097/HJH.0b013e328308da66.

  PMID: 18622223 BACKGROUND

• Stergiou GS, Bliziotis IA. Home blood pressure monitoring in the diagnosis and treatment of hypertension: a systematic review. Am J Hypertens. 2011 Feb;24(2):123-34. doi: 10.1038/ajh.2010.194. Epub 2010 Sep 9.

  PMID: 20940712 BACKGROUND

• da Silva GV, de Barros S, Abensur H, Ortega KC, Mion D Jr; Cochrane Renal Group Prospective Trial Register: CRG060800146. Home blood pressure monitoring in blood pressure control among haemodialysis patients: an open randomized clinical trial. Nephrol Dial Transplant. 2009 Dec;24(12):3805-11. doi: 10.1093/ndt/gfp332. Epub 2009 Jul 8.

  PMID: 19586971 BACKGROUND

• Hosseininasab M, Jahangard-Rafsanjani Z, Mohagheghi A, Sarayani A, Rashidian A, Javadi M, Ahmadvand A, Hadjibabaie M, Gholami K. Self-monitoring of blood pressure for improving adherence to antihypertensive medicines and blood pressure control: a randomized controlled trial. Am J Hypertens. 2014 Nov;27(11):1339-45. doi: 10.1093/ajh/hpu062. Epub 2014 Apr 26.

  PMID: 24771706 BACKGROUND

• Botdorf J, Chaudhary K, Whaley-Connell A. Hypertension in Cardiovascular and Kidney Disease. Cardiorenal Med. 2011;1(3):183-192. doi: 10.1159/000329927. Epub 2011 Jul 30.

  PMID: 22096454 BACKGROUND

• Judd E, Calhoun DA. Management of hypertension in CKD: beyond the guidelines. Adv Chronic Kidney Dis. 2015 Mar;22(2):116-22. doi: 10.1053/j.ackd.2014.12.001.

  PMID: 25704348 BACKGROUND

• Gansevoort RT, Correa-Rotter R, Hemmelgarn BR, Jafar TH, Heerspink HJ, Mann JF, Matsushita K, Wen CP. Chronic kidney disease and cardiovascular risk: epidemiology, mechanisms, and prevention. Lancet. 2013 Jul 27;382(9889):339-52. doi: 10.1016/S0140-6736(13)60595-4. Epub 2013 May 31.

  PMID: 23727170 BACKGROUND

• Bello AK, Levin A, Tonelli M, Okpechi IG, Feehally J, Harris D, Jindal K, Salako BL, Rateb A, Osman MA, Qarni B, Saad S, Lunney M, Wiebe N, Ye F, Johnson DW. Assessment of Global Kidney Health Care Status. JAMA. 2017 May 9;317(18):1864-1881. doi: 10.1001/jama.2017.4046.

  PMID: 28430830 BACKGROUND

• Akobeng AK. Principles of evidence based medicine. Arch Dis Child. 2005 Aug;90(8):837-40. doi: 10.1136/adc.2005.071761.

  PMID: 16040884 BACKGROUND

• Kabisch M, Ruckes C, Seibert-Grafe M, Blettner M. Randomized controlled trials: part 17 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2011 Sep;108(39):663-8. doi: 10.3238/arztebl.2011.0663. Epub 2011 Sep 30.

  PMID: 22013494 BACKGROUND

• Levin KA. Study design VII. Randomised controlled trials. Evid Based Dent. 2007;8(1):22-3. doi: 10.1038/sj.ebd.6400473.

  PMID: 17380181 BACKGROUND

• Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.

  PMID: 23817082 BACKGROUND

• DeLoach SS, Townsend RR. Vascular stiffness: its measurement and significance for epidemiologic and outcome studies. Clin J Am Soc Nephrol. 2008 Jan;3(1):184-92. doi: 10.2215/CJN.03340807.

  PMID: 18178784 BACKGROUND

• Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.

  PMID: 17000623 BACKGROUND

• Kidney Disease Outcomes Quality Initiative (K/DOQI). K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis. 2004 May;43(5 Suppl 1):S1-290. No abstract available.

  PMID: 15114537 BACKGROUND

• Sarafidis PA, Ruilope LM. Aggressive blood pressure reduction and renin-angiotensin system blockade in chronic kidney disease: time for re-evaluation? Kidney Int. 2014 Mar;85(3):536-46. doi: 10.1038/ki.2013.355. Epub 2013 Sep 18.

  PMID: 24048382 BACKGROUND

• Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005 Jan 15-21;365(9455):217-23. doi: 10.1016/S0140-6736(05)17741-1.

  PMID: 15652604 BACKGROUND

• Muntner P, Carey RM, Gidding S, Jones DW, Taler SJ, Wright JT Jr, Whelton PK. Potential US Population Impact of the 2017 ACC/AHA High Blood Pressure Guideline. Circulation. 2018 Jan 9;137(2):109-118. doi: 10.1161/CIRCULATIONAHA.117.032582. Epub 2017 Nov 13.

  PMID: 29133599 BACKGROUND

• Levin A, Tonelli M, Bonventre J, Coresh J, Donner JA, Fogo AB, Fox CS, Gansevoort RT, Heerspink HJL, Jardine M, Kasiske B, Kottgen A, Kretzler M, Levey AS, Luyckx VA, Mehta R, Moe O, Obrador G, Pannu N, Parikh CR, Perkovic V, Pollock C, Stenvinkel P, Tuttle KR, Wheeler DC, Eckardt KU; ISN Global Kidney Health Summit participants. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet. 2017 Oct 21;390(10105):1888-1917. doi: 10.1016/S0140-6736(17)30788-2. Epub 2017 Apr 20.

  PMID: 28434650 BACKGROUND

• Kalaitzidis RG, Elisaf MS. Treatment of Hypertension in Chronic Kidney Disease. Curr Hypertens Rep. 2018 Jun 11;20(8):64. doi: 10.1007/s11906-018-0864-0.

  PMID: 29892833 BACKGROUND

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic; Masked Hypertension; White Coat Hypertension; Renal Insufficiency

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Central Study Contacts

Eleni Champidou, MD

CONTACT

00306936900548; echampidou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Internal Medicine Specialist

Study Record Dates

• First Submitted: June 30, 2018
• First Posted: July 17, 2018
• Study Start: June 2, 2018
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

GR (1)