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Primary HypertensionSTEPNCT03015311

Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients

A study of Primary Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 42 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Primary Hypertension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,000 participants
Where
42 sitesChina
Study dates
15 Jan 2017to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 15Show fewer
  • 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.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

China42 sites

  • The Second Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 014030

  • Beijing Chaoyang Hospital affiliated to Capical Medical University

    Beijing, Beijing Municipality, 100020

  • Bei Jing Hospital

    Beijing, Beijing Municipality, 100037

  • Chinese Academy of Medical Sciences, FuWai Hospital

    Beijing, Beijing Municipality, 100037

  • Xuanwu hospital of capital medical university

    Beijing, Beijing Municipality, 100053

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Pinggu Hospital

    Beijing, Beijing Municipality

  • Benxi Railway Hospital

    Benxi, Liaoning, 117000

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The 1st Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Guangdong Cardiovascular Institute

    Guangzhou, Guangdong, 510080

  • First affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong, 516001

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Jining First People's Hospital

    Jining, Shandong, 272011

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

    Kunming, Yunnan, 650051

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101

  • The First Hospital of Kunming

    Kunming, Yunnan

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • the Second Affiliated Hospitalof NanChang University

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • The First Affiliated Hospital of Guangxi University of Chinese Medicine

    Nanning, Guangxi, 530023

  • Shanghai general hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200080

  • The Second Affiliated Hospital to Medical College Shantou University Guangdong

    Shantou, Guangdong, 515041

  • Shenzhen Sun Yat-sen Cardiovascular Hospital

    Shenzhen, Guangdong, 518001

  • Hong xinglong center hospital

    Shuangyashan, Heilongjiang

  • College of Medicine , National Taiwan University

    Taibei, Taiwan

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Shanxi caidiovascular hospital

    Taiyuan, Shanxi, 030024

  • Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital

    Taiyuan, Shanxi, 030032

  • Kailua General Hospital

    Tangshan, Hebei, 063000

  • Pingjin Hospital, Logistics University of PAPF

    Tianjin, Tianjin Municipality, 300162

  • the People's Hospital of Ji Xian Distric

    Tianjin, Tianjin Municipality

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • First Affiliated Hospital, Xian Jiaotong University

    Xi’an, Shanxi, 710061

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia

  • Kang Ya Hospita

    Yiyang, Hunan, 413000

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei, 075000

  • First Affiliated Hospitalof Zhengzhou University

    Zhengzhou, Henan, 450000

  • Zhenjiang First People's Hospital

    Zhenjiang, Jiangsu, 212002

  • Zhoukou City Central Hospital

    Zhoukou, Henan, 466000

Other trials in China

About this study

Official title: Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial

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.

Read the detailed description

Hypertension is highly prevalent in the adult population in China, and its burden is rapidly increasing among persons older than 60 years of age. Elevated blood pressure (BP) is an important public health concern which contributes to several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. Clinical trials have shown that a lower systolic blood pressure goal will lead to greater reduction in cardiovascular disease (CVD) incidence, but the effect of intensive treatment of systolic blood pressure below 120 mm Hg in reducing of CVD risk has long been debated. In particularly, among the elderly hypertensive patients aged 60 years or older, the most appropriate targets for blood pressure lowering to reduce cardiovascular events still remain uncertain.

The STEP trial will randomize about 8000 participants aged between 60 and 80 years with SBP≥140 mm Hg and <190 mm Hg, and without a history of atherothrombotic or hemorrhagic stroke. Target SBP goals are 110-130 vs 130-150 mm Hg, respectively. The purpose of the STEP 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 hypertensive patients between 60-80 years. Participants will be recruited at approximately 40 clinic centers in China within approximately a 1-year period, and will be followed for 4 years. 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.

Being tested
Intensive BP control, Standard BP control
Keywords
Blood pressure control
Medical subject headings
Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive BP controlDrug

    Also called Lower target for reducing SBP

    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.

  • Standard BP controlDrug

    Also called Standard target for reducing SBP

    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.

Study groups in NCT03015311
Study groupRoleWhat they receive
Intensive BP controlExperimentalSBP within 110 - <130 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 110 - <130 mm Hg.
Receives: Drug: Intensive BP control
Standard BP controlActive comparatorSBP within 130 - <150 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 130 - <150 mm Hg.
Receives: Drug: Standard BP control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 years

Secondary outcomes (12)

  1. Composite of major adverse cardiac events (primary outcome without stroke)

    Composite of major adverse cardiac events comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), atrial fibrillation, and death from cardiovascular causes.

    Measured: 4 years

  2. First occurrence of symptomatic stroke ( ischemic or hemorrhagic)

    Stroke is defined as a rapid onset of focal (or global) disturbance of cerebral function lasting more than 24 hours (except interrupted by surgery or death) without resolution of symptoms according to the World Health Organization. The diagnosis of stroke is confirmed by strict neurological examination, computed tomography (CT), or magnetic resonance imaging (MRI), and stroke subtypes are classified including ischemic or hemorrhagic, fatal or not fatal.

    Measured: 4 years

  3. Acute coronary syndrome

    Acute coronary syndrome includes myocardial infarction and hospitalization for unstable angina. The diagnosis of MI is based on the following criteria: (1) Patient has cardiac signs and symptoms, such as retrosternal pain last for at least 30 minutes, and not relieve to nitroglycerine during the attack; (2) Electrocardiographic abnormal findings of MI are observed; (3) Biochemical markers of cardiac damage are present.

    The diagnosis of unstable angina requires hospitalization for evaluation. The clinical presentation of unstable angina includes: (1) prolonged (>20 min) angina pain at rest; (2) new onset angina; (3) post-MI angina; (4) recent destabilization of previously stable angina with at least Canadian Cardiovascular Society Class III angina characteristics.

    Measured: 4 years

  4. Hospitalization for acute decompensated heart failure

    Diagnosis of acute decompensated heart failure requires a hospitalization or emergency department visit which provides an infusion therapy for clinical signs and symptoms consistent with cardiac decompensation or inadequate cardiac pump function, such as increasing or new onset shortness of breath, peripheral edema, paroxysmal dyspnea, orthopnea, or hypoxia.

    Measured: 4 years

  5. coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG])

    Patients are treated with coronary revascularization by either PCI or CABG due to acute coronary syndromes (ACS) and stable ischemic heart disease (SIHD).

    Measured: 4 years

  6. Atrial fibrillation

    Diagnosis of AF requires rhythm evidence of an ECG showing the typical pattern including absolutely irregular RR intervals and no discernible, distinct P waves.

    Measured: 4 years

  7. Cardiovascular death

    Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death.

    Measured: 4 years

  8. All-cause death

    All-cause death includes death due to any reasons during the trial. Evidence for death includes death certificates from hospitals or reports of home visit from investigators.

    Measured: 4 years

  9. First occurrence of diabetes mellitus

    Diagnosis of incident diabetes mellitus includes the following criteria: (1) Fasting plasma glucose ≥ 126 mg/dl (≥ 7.0 mmol/dl); or (2) Oral glucose tolerance test 2-hour glucose in venous plasma ≥ 200 mg/dl (≥ 11.1 mmol/l); or (3) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (≥ 11.1 mmol/l); or (4) Glycosylated hemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol).

    Measured: 4 years

  10. Decline in cognitive function

    Decline in cognitive function includes sensory disturbance, memory disorders and thinking disorders, which is assessed by mini-mental state examination (MMSE)

    Measured: 4 years

  11. Decline in renal function or development of end stage renal disease (ESRD)

    Decline in renal function is assessed by any of the following: (1) For patients with chronic kidney disease (eGFR <60 ml per minute per 1.73 m2) at baseline, the renal outcome was a composite of a decrease in the eGFR of 50% or more (confirmed by a subsequent laboratory test) or the development of ESRD requiring long-term dialysis or kidney transplantation; or (2) For participants without chronic kidney disease at baseline, the renal outcome was defined by a decrease in the eGFR of 30% or more to a value of less than 60 ml per minute per 1.73 m2.

    Measured: 4 years

  12. Major artery stiffness

    Major artery stiffness are assessed by a composite of decrease in the ankle brachial index [ABI], brachial-ankle pulse wave velocity(baPWV), or brachial artery flow-mediated dilation [FMD].

    ABI and baPWV,well-established non-invasive techniques for evaluating obstruction and stiffness of peripheral artery respectively, are considered for the purposes of cardiovascular risk assessment. ABI is the ratio of the average systolic blood pressure measured in brachial/ankle, and an ABI between and including 0.9 and 1.2 is considered normal, while a lesser than 0.9 indicates arterial disease. The unit measure of baPWV value is cm per second.

    FMD serves as an index of nitric oxide (NO)-mediated endothelium-dependent vasodilator function in humans and is regarded as a surrogate marker of cardiovascular disease.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2017 (estimated)
  2. Study start15 Jan 2017
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
8,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03015311
Sponsor's protocol ID
2016CXGC07
Other IDs
2016-I2M-1-006
Acronym
STEP
Status last verified
Jul 2021
First submitted
2 Jan 2017
Last updated
28 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Within 3 years after the trial complete

Publications

  • 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.

    PubMed 26603746

  • 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.

    PubMed 26551272

  • 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.

    PubMed 20228401

  • 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.

    PubMed 2676266

  • 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.

    PubMed 19139601

  • Zhuang M, Peng X, Song Q, Bai J, Yu M, Cai J. Systolic blood pressure time-in-target range and kidney outcomes in patients with hypertension: Findings from the STEP trial. Chin Med J (Engl). 2026 Jun 20;139(12):1821-1828. doi: 10.1097/CM9.0000000000004118. Epub 2026 May 8.

    PubMed 42104210

  • Chen S, Ji Y, Yang R, Peng X, Bai J, Fan X, Song Q, Cai J. Influence of Baseline Smoking Status on Intensive Blood Pressure Control: Results From the STEP Randomized Trial. Can J Cardiol. 2026 Apr 21:S0828-282X(26)00361-2. doi: 10.1016/j.cjca.2026.04.005. Online ahead of print.

    PubMed 42025692

  • Ling Q, Deng Y, Dong X, Song Q, Cai J. Effect of Hypertension Duration on the Associations Between Intensive Blood Pressure Control and Cardiac, Vascular, and Kidney Organ Damage. J Am Heart Assoc. 2026 Mar 17;15(6):e041556. doi: 10.1161/JAHA.125.041556. Epub 2026 Mar 13.

    PubMed 41823241

  • 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.

    PubMed 41105077

  • 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.

    PubMed 40858751

  • 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. 2026 May 15;33(7):1218-1226. doi: 10.1093/eurjpc/zwaf507.

    PubMed 40796327

  • 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.

    PubMed 40598287

  • 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.

    PubMed 39016010

  • 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.

    PubMed 38600278

  • 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.

    PubMed 38514823

Questions about this trial

What is this clinical trial studying?

A study of Primary Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 42 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary composite outcome (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03015311, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.

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