Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients
STEP
Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial
2 other identifiers
interventional
8,000
1 country
42
Brief Summary
The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a 2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The purpose of this trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (\<130 mmHg, intensive treatment) than currently recommended (\<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of old. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
January 10, 2017
CompletedStudy Start
First participant enrolled
January 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 28, 2021
July 1, 2021
4 years
January 2, 2017
July 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary composite outcome
A composite end-point comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), first occurrence of symptomatic stroke ( ischemic or hemorrhagic stroke), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention \[PCI\], coronary artery bypass grafting \[CABG\]), atrial fibrillation, and death from cardiovascular causes.
4 years
Secondary Outcomes (12)
Composite of major adverse cardiac events (primary outcome without stroke)
4 years
First occurrence of symptomatic stroke ( ischemic or hemorrhagic)
4 years
Acute coronary syndrome
4 years
Hospitalization for acute decompensated heart failure
4 years
coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG])
4 years
- +7 more secondary outcomes
Study Arms (2)
Intensive BP control
EXPERIMENTALSBP within 110 - \<130 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 110 - \<130 mm Hg.
Standard BP control
ACTIVE COMPARATORSBP within 130 - \<150 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 130 - \<150 mm Hg.
Interventions
For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy. Other drugs, including hydrochlorothiazide and β-blockers, are allowed, in order to achieve the SBP target. If the target BP level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy. Other drugs, including hydrochlorothiazide and β-blockers, are allowed, in order to achieve the SBP target. If the target BP level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
Eligibility Criteria
You may qualify if:
- Systolic BP between 140-190 mm Hg in the three screening visits or currently under anti-hypertension treatment;
- An age of 60 - 80 years old;
- Signed the written informed consent.
You may not qualify if:
- Systolic BP≥190 mm Hg, or diastolic BP \<60 mm Hg;
- Known secondary cause of hypertension;
- History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack \[TIA\]);
- Hospitalization for myocardial infarction or unstable angina within the previous 6 months;
- Coronary revascularization (PCI or CABG) within the previous 12 months;
- Planned to perform coronary revascularization (PCI or CABG) in the future 12 months;
- History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure;
- NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months;
- Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial;
- Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease;
- Uncontrolled diabetes (serum fasting glucose ≥200 mg/dl \[11.1 mmol/L\], HbA1\>8%);
- Lab tests indicating abnormal liver or kidney function (ALT more than 3 times the upper limit of normal value, or end stage renal disease (ESRD) on dialysis, or estimated glomerular filtration rate (eGFR) \<30 mL/min, or serum creatine \>2.5 mg/dl \[\>221 umol/L\];
- Severe somatic disease such as cancer;
- Severe cognitive impairment or mental disorders;
- Participating in other clinical trials.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Beijing Chaoyang Hospital affiliated to Capical Medical University
Beijing, Beijing Municipality, 100020, China
Bei Jing Hospital
Beijing, Beijing Municipality, 100037, China
Chinese Academy of Medical Sciences, FuWai Hospital
Beijing, Beijing Municipality, 100037, China
Xuanwu hospital of capital medical university
Beijing, Beijing Municipality, 100053, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Guangdong Cardiovascular Institute
Guangzhou, Guangdong, 510080, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001, China
The Second Affiliated Hospital to Medical College Shantou University Guangdong
Shantou, Guangdong, 515041, China
Shenzhen Sun Yat-sen Cardiovascular Hospital
Shenzhen, Guangdong, 518001, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, 530023, China
Kailua General Hospital
Tangshan, Hebei, 063000, China
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 075000, China
First affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Hong xinglong center hospital
Shuangyashan, Heilongjiang, China
First Affiliated Hospitalof Zhengzhou University
Zhengzhou, Henan, 450000, China
Zhoukou City Central Hospital
Zhoukou, Henan, 466000, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Kang Ya Hospita
Yiyang, Hunan, 413000, China
The Second Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014030, China
Zhenjiang First People's Hospital
Zhenjiang, Jiangsu, 212002, China
the Second Affiliated Hospitalof NanChang University
Nanchang, Jiangxi, 330006, China
Benxi Railway Hospital
Benxi, Liaoning, 117000, China
The 1st Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The First People's Hospital of Yinchuan
Yinchuan, Ningxia, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Jining First People's Hospital
Jining, Shandong, 272011, China
Shanghai general hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200080, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Shanxi caidiovascular hospital
Taiyuan, Shanxi, 030024, China
Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital
Taiyuan, Shanxi, 030032, China
First Affiliated Hospital, Xian Jiaotong University
Xi’an, Shanxi, 710061, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
College of Medicine , National Taiwan University
Taibei, Taiwan, China
Pingjin Hospital, Logistics University of PAPF
Tianjin, Tianjin Municipality, 300162, China
the People's Hospital of Ji Xian Distric
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Yan'an Hospital affiliated to kunming medical university, Yunnan Cardiovascular Hospital
Kunming, Yunnan, 650051, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101, China
The First Hospital of Kunming
Kunming, Yunnan, China
Related Publications (31)
Wang Y, Peng X, Nie X, Chen L, Weldon R, Zhang W, Xiao D, Cai J. Burden of hypertension in China over the past decades: Systematic analysis of prevalence, treatment and control of hypertension. Eur J Prev Cardiol. 2016 May;23(8):792-800. doi: 10.1177/2047487315617105. Epub 2015 Nov 24.
PMID: 26603746BACKGROUNDSPRINT 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.
PMID: 26551272BACKGROUNDACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
PMID: 20228401BACKGROUNDProbstfield JL, Applegate WB, Borhani NO, Curb JD, Cutler JA, Davis BR, Furberg CD, Hawkins CM, Lakatos E, Page LB, et al. The Systolic Hypertension in the Elderly Program (SHEP): an intervention trial on isolated systolic hypertension. SHEP Cooperative Research Group. Clin Exp Hypertens A. 1989;11(5-6):973-89. doi: 10.3109/10641968909035386.
PMID: 2676266BACKGROUNDJATOS Study Group. Principal results of the Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS). Hypertens Res. 2008 Dec;31(12):2115-27. doi: 10.1291/hypres.31.2115.
PMID: 19139601BACKGROUNDSong Q, Peng X, Bai J, Yang R, Ling Q, Chen S, Ji Y, Dong X, Wang X, Wu S, Wang TD, Yu X, Liu H, Ren J, Zhou X, Chen R, Yang L, Yang J, Tian G, Zhang H, Zhao D, Chen F, Li D, Yu J, Zhang J, Yang Z, Zhang W, Cai J. Intensive Blood Pressure Control in Older Patients With Hypertension: 6-Year Results of the STEP Trial. J Am Coll Cardiol. 2025 Oct 28;86(17):1421-1433. doi: 10.1016/j.jacc.2025.06.045. Epub 2025 Oct 17.
PMID: 41105077DERIVEDJi Y, Peng X, Chen S, Song Q, Bai J, Cai J. Evening home pulse pressure predicted cardiovascular events and mortality in older adults with hypertension: findings based on the STEP trial. Hypertens Res. 2025 Nov;48(11):2801-2810. doi: 10.1038/s41440-025-02349-y. Epub 2025 Aug 26.
PMID: 40858751DERIVEDDong X, Bai J, Ling Q, Zhao X, Cai J. Effect of Intensive Blood Pressure Control in Patients with Resistant Hypertension: Insights from the STEP Trial. Eur J Prev Cardiol. 2025 Aug 12:zwaf507. doi: 10.1093/eurjpc/zwaf507. Online ahead of print.
PMID: 40796327DERIVEDPeng X, Olsen MH, Pareek M, Bai J, Liu Y, Song Q, Cai J. Impact of antihypertensive drug classes on cardiovascular outcomes: insights from the STEP study. BMC Med. 2025 Jul 1;23(1):365. doi: 10.1186/s12916-025-04158-z.
PMID: 40598287DERIVEDLing Q, Dong X, Bai J, Deng Y, Song Q, Cai J. Impact of Hypertension Duration on the Cardiovascular Benefit of Intensive Blood Pressure Control. Hypertension. 2024 Sep;81(9):1945-1955. doi: 10.1161/HYPERTENSIONAHA.124.23439. Epub 2024 Jul 17.
PMID: 39016010DERIVEDZhang K, Song Q, Bai J, Cai J. Association of intensive blood pressure management with cardiovascular outcomes in patients using multiple classes of antihypertensive medications: a post-hoc analysis of the STEP Trial. Hypertens Res. 2024 Jul;47(7):1779-1788. doi: 10.1038/s41440-024-01647-1. Epub 2024 Apr 10.
PMID: 38600278DERIVEDZhao S, Deng Y, Wang Y, Yu S, Han J, Cai J, Zhang Y. Incidence and prognosis of cardiac conduction system diseases in hypertension: the STEP trial. Nat Aging. 2024 Apr;4(4):483-490. doi: 10.1038/s43587-024-00591-6. Epub 2024 Mar 21.
PMID: 38514823DERIVEDYang R, Zhang J, Yu X, Yang G, Cai J. Remnant cholesterol and intensive blood pressure control in older patients with hypertension: a post hoc analysis of the STEP randomized trialdagger. Eur J Prev Cardiol. 2024 Jun 3;31(8):997-1004. doi: 10.1093/eurjpc/zwae001.
PMID: 38167928DERIVEDZhang S, Zhong Y, Wu S, Wu H, Cai J, Zhang W; STEP Study Group. Intensive blood pressure control on arterial stiffness among older patients with hypertension. Chin Med J (Engl). 2024 May 5;137(9):1078-1087. doi: 10.1097/CM9.0000000000002868. Epub 2023 Nov 15.
PMID: 37968125DERIVEDYang R, Huang R, Zhang L, Li D, Luo J, Cai J. Influence of Baseline Diastolic Blood Pressure on the Effects of Intensive Blood Pressure Lowering: Results From the STEP Randomized Trial. Hypertension. 2023 Dec;80(12):2572-2580. doi: 10.1161/HYPERTENSIONAHA.123.21892. Epub 2023 Oct 10.
PMID: 37814892DERIVEDGonzalez-Vilchez F, Hernandez-Perez F, Almenar-Bonet L, Crespo-Leiro MG, Lopez-Granados A, Ortiz-Bautista C, Delgado-Jimenez JF, de Antonio-Ferrer M, Sobrino-Marquez JM, Garcia-Romero E; Spanish Heart Transplant Teams. Spanish heart transplant registry. 34th official report of the Heart Failure Association of the Spanish Society of Cardiology. Rev Esp Cardiol (Engl Ed). 2023 Nov;76(11):901-909. doi: 10.1016/j.rec.2023.06.013. Epub 2023 Sep 6. English, Spanish.
PMID: 37683823DERIVEDWang X, Feng Y, Yang L, Zhang G, Tian X, Ling Q, Tan J, Cai J. Association of baseline serum cholesterol with benefits of intensive blood pressure control. Chin Med J (Engl). 2023 Sep 5;136(17):2058-2065. doi: 10.1097/CM9.0000000000002474.
PMID: 37525354DERIVEDDeng Y, Bai J, Yang X, Liu W, Guo Z, Zhang J, Huang R, Yang X, Yu C, Yu J, Guo X, Wu H, Liu P, Zhang W, Cai J. Achieved systolic blood pressure and cardiovascular outcomes in 60-80-year-old patients: the Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial. Eur J Prev Cardiol. 2023 Aug 1;30(10):1017-1027. doi: 10.1093/eurjpc/zwad142.
PMID: 37172116DERIVEDYu J, Song Q, Bai J, Wu S, Bu P, Li Y, Cai J. Visit-to-Visit Blood Pressure Variability and Cardiovascular Outcomes in Patients Receiving Intensive Versus Standard Blood Pressure Control: Insights From the STEP Trial. Hypertension. 2023 Jul;80(7):1507-1516. doi: 10.1161/HYPERTENSIONAHA.122.20376. Epub 2023 May 12.
PMID: 37170806DERIVEDYang R, Zhu Y, Xu M, Tao Y, Cong W, Cai J. Intensive blood pressure lowering and the risk of new-onset diabetes in patients with hypertension: a post-hoc analysis of the STEP randomized trial. Eur J Prev Cardiol. 2023 Aug 1;30(10):988-995. doi: 10.1093/eurjpc/zwad105.
PMID: 37036035DERIVEDFan J, Bai J, Liu W, Cai J. Effects of intensive vs. standard blood pressure control on cognitive function: Post-hoc analysis of the STEP randomized controlled trial. Front Neurol. 2023 Feb 1;14:1042637. doi: 10.3389/fneur.2023.1042637. eCollection 2023.
PMID: 36816574DERIVEDWang XQ, Tan JS, Zhang SY, Zhang WL, Cai J. Association of serum uric acid with benefits of intensive blood pressure control. Rev Esp Cardiol (Engl Ed). 2023 Aug;76(8):635-644. doi: 10.1016/j.rec.2023.01.003. Epub 2023 Jan 28. English, Spanish.
PMID: 36716991DERIVEDSaiz 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. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
PMID: 36398903DERIVEDLing Q, Song Q, Bai J, Wu S, Zhang W, Chen M, Cai J. Temporal Relationship Between Arterial Stiffness and Systolic Blood Pressure Under Intensive or Standard Control: A Post Hoc Analysis of the STEP Trial. Hypertension. 2022 Dec;79(12):2755-2763. doi: 10.1161/HYPERTENSIONAHA.122.20022. Epub 2022 Oct 24.
PMID: 36278416DERIVEDSong Q, Ling Q, Bai J, Zhang H, Bu P, Chen F, Wu S, Zhang W, Chen M, Cai J. Influence of baseline arterial stiffness on effects of intensive compared with standard blood pressure control: a post hoc analysis of the STEP trial. BMC Med. 2022 Oct 20;20(1):358. doi: 10.1186/s12916-022-02556-1.
PMID: 36261812DERIVEDFan J, Zheng W, Liu W, Xu J, Zhou L, Liu S, Bai J, Qi Y, Huang W, Liu K, Cai J. Cost-Effectiveness of Intensive Versus Standard Blood Pressure Treatment in Older Patients With Hypertension in China. Hypertension. 2022 Nov;79(11):2631-2641. doi: 10.1161/HYPERTENSIONAHA.122.20051. Epub 2022 Sep 30.
PMID: 36177835DERIVEDZhang S, Zhong Y, Wang L, Yin X, Li Y, Liu Y, Dai Q, Tong A, Li D, Zhang L, Li P, Zhang G, Huang R, Liu J, Zhao L, Yu J, Zhang X, Yang L, Cai J, Zhang W; STEP Study Group. Anxiety, home blood pressure monitoring, and cardiovascular events among older hypertension patients during the COVID-19 pandemic. Hypertens Res. 2022 May;45(5):856-865. doi: 10.1038/s41440-022-00852-0. Epub 2022 Jan 21.
PMID: 35064249DERIVEDZhang W, Zhang S, Deng Y, Wu S, Ren J, Sun G, Yang J, Jiang Y, Xu X, Wang TD, Chen Y, Li Y, Yao L, Li D, Wang L, Shen X, Yin X, Liu W, Zhou X, Zhu B, Guo Z, Liu H, Chen X, Feng Y, Tian G, Gao X, Kario K, Cai J; STEP Study Group. Trial of Intensive Blood-Pressure Control in Older Patients with Hypertension. N Engl J Med. 2021 Sep 30;385(14):1268-1279. doi: 10.1056/NEJMoa2111437. Epub 2021 Aug 30.
PMID: 34491661DERIVEDZhang S, Zhou X, Chen Y, Wang L, Zhu B, Jiang Y, Bu P, Liu W, Li D, Li Y, Tao Y, Ren J, Fu L, Li Y, Shen X, Liu H, Sun G, Xu X, Bai J, Zhang W, Cai J; STEP Study Group. Changes in Home Blood Pressure Monitored Among Elderly Patients With Hypertension During the COVID-19 Outbreak: A Longitudinal Study in China Leveraging a Smartphone-Based Application. Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007098. doi: 10.1161/CIRCOUTCOMES.120.007098. Epub 2021 May 18.
PMID: 34003685DERIVEDSaiz 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.
PMID: 32905623DERIVEDZhang S, Wu S, Ren J, Chen X, Zhang X, Feng Y, Zhou X, Zhu B, Yang J, Tian G, Jiang Y, Guo Z, Li Y, Wang TD, Kario K, Zhang W, Cai J; STEP Study Group. Strategy of blood pressure intervention in the elderly hypertensive patients (STEP): Rational, design, and baseline characteristics for the main trial. Contemp Clin Trials. 2020 Feb;89:105913. doi: 10.1016/j.cct.2019.105913. Epub 2019 Dec 12.
PMID: 31838255DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jun Cai, MD
Chinese Academy of Medical Sciences, Fuwai Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Hypertension Center
Study Record Dates
First Submitted
January 2, 2017
First Posted
January 10, 2017
Study Start
January 15, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
July 28, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Within 3 years after the trial complete
- Access Criteria
- To share IPD in the magazine of paper published
Within 3 years after the trial complete