NCT03015311

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

42 active sites

Status
unknown

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

January 15, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

4 years

First QC Date

January 2, 2017

Last Update Submit

July 22, 2021

Conditions

Keywords

Blood pressure control

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

EXPERIMENTAL

SBP within 110 - \<130 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 110 - \<130 mm Hg.

Drug: Intensive BP control

Standard BP control

ACTIVE COMPARATOR

SBP within 130 - \<150 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 130 - \<150 mm Hg.

Drug: Standard BP control

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.

Also known as: Lower target for reducing SBP
Intensive BP control

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.

Also known as: Standard target for reducing SBP
Standard BP control

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Bei Jing Hospital

Beijing, Beijing Municipality, 100037, China

Location

Chinese Academy of Medical Sciences, FuWai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Xuanwu hospital of capital medical university

Beijing, Beijing Municipality, 100053, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing Pinggu Hospital

Beijing, Beijing Municipality, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location

Guangdong Cardiovascular Institute

Guangzhou, Guangdong, 510080, China

Location

Huizhou Municipal Central Hospital

Huizhou, Guangdong, 516001, China

Location

The Second Affiliated Hospital to Medical College Shantou University Guangdong

Shantou, Guangdong, 515041, China

Location

Shenzhen Sun Yat-sen Cardiovascular Hospital

Shenzhen, Guangdong, 518001, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

The First Affiliated Hospital of Guangxi University of Chinese Medicine

Nanning, Guangxi, 530023, China

Location

Kailua General Hospital

Tangshan, Hebei, 063000, China

Location

The First Affiliated Hospital of Hebei North University

Zhangjiakou, Hebei, 075000, China

Location

First affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Hong xinglong center hospital

Shuangyashan, Heilongjiang, China

Location

First Affiliated Hospitalof Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Zhoukou City Central Hospital

Zhoukou, Henan, 466000, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Kang Ya Hospita

Yiyang, Hunan, 413000, China

Location

The Second Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, 014030, China

Location

Zhenjiang First People's Hospital

Zhenjiang, Jiangsu, 212002, China

Location

the Second Affiliated Hospitalof NanChang University

Nanchang, Jiangxi, 330006, China

Location

Benxi Railway Hospital

Benxi, Liaoning, 117000, China

Location

The 1st Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Jining First People's Hospital

Jining, Shandong, 272011, China

Location

Shanghai general hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200080, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Shanxi caidiovascular hospital

Taiyuan, Shanxi, 030024, China

Location

Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital

Taiyuan, Shanxi, 030032, China

Location

First Affiliated Hospital, Xian Jiaotong University

Xi’an, Shanxi, 710061, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

College of Medicine , National Taiwan University

Taibei, Taiwan, China

Location

Pingjin Hospital, Logistics University of PAPF

Tianjin, Tianjin Municipality, 300162, China

Location

the People's Hospital of Ji Xian Distric

Tianjin, Tianjin Municipality, China

Location

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

Yan'an Hospital affiliated to kunming medical university, Yunnan Cardiovascular Hospital

Kunming, Yunnan, 650051, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650101, China

Location

The First Hospital of Kunming

Kunming, Yunnan, China

Location

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: 26603746BACKGROUND
  • 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.

    PMID: 26551272BACKGROUND
  • ACCORD 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: 20228401BACKGROUND
  • Probstfield 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: 2676266BACKGROUND
  • JATOS 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: 19139601BACKGROUND
  • Song 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.

  • Ji 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.

  • Dong 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.

  • Peng 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.

  • Ling 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.

  • Zhang 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.

  • Zhao 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.

  • Yang 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.

  • Zhang 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.

  • Yang 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.

  • Gonzalez-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.

  • Wang 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.

  • Deng 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.

  • Yu 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.

  • Yang 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.

  • Fan 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.

  • Wang 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.

  • 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. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.

  • Ling 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.

  • Song 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.

  • Fan 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.

  • Zhang 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.

  • Zhang 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.

  • Zhang 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.

  • 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.

  • Zhang 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.

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Jun Cai, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY DIRECTOR

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

Within 3 years after the trial complete

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

Locations