Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP)
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| ClinicalTrials.gov Identifier: NCT03015311 |
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Recruitment Status :
Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : July 28, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Primary Hypertension | Drug: Intensive BP control Drug: Standard BP control | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 8000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial |
| Actual Study Start Date : | January 15, 2017 |
| Actual Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intensive BP control
SBP within 110 - <130 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 110 - <130 mm Hg.
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Drug: 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.
Other Name: Lower target for reducing SBP |
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Active Comparator: Standard BP control
SBP within 130 - <150 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 130 - <150 mm Hg.
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Drug: Standard 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.
Other Name: Standard target for reducing SBP |
- Primary composite outcome [ Time Frame: 4 years ]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.
- Composite of major adverse cardiac events (primary outcome without stroke) [ Time Frame: 4 years ]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.
- First occurrence of symptomatic stroke ( ischemic or hemorrhagic) [ Time Frame: 4 years ]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.
- Acute coronary syndrome [ Time Frame: 4 years ]
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.
- Hospitalization for acute decompensated heart failure [ Time Frame: 4 years ]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.
- coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]) [ Time Frame: 4 years ]Patients are treated with coronary revascularization by either PCI or CABG due to acute coronary syndromes (ACS) and stable ischemic heart disease (SIHD).
- Atrial fibrillation [ Time Frame: 4 years ]Diagnosis of AF requires rhythm evidence of an ECG showing the typical pattern including absolutely irregular RR intervals and no discernible, distinct P waves.
- Cardiovascular death [ Time Frame: 4 years ]Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death.
- All-cause death [ Time Frame: 4 years ]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.
- First occurrence of diabetes mellitus [ Time Frame: 4 years ]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).
- Decline in cognitive function [ Time Frame: 4 years ]Decline in cognitive function includes sensory disturbance, memory disorders and thinking disorders, which is assessed by mini-mental state examination (MMSE)
- Decline in renal function or development of end stage renal disease (ESRD) [ Time Frame: 4 years ]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.
- Major artery stiffness [ Time Frame: 4 years ]
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.
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| Ages Eligible for Study: | 60 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015311
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| Study Director: | Jun Cai, MD | Chinese Academy of Medical Sciences, Fuwai Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jun Cai, Director, Hypertension Center, Chinese Academy of Medical Sciences, Fuwai Hospital |
| ClinicalTrials.gov Identifier: | NCT03015311 |
| Other Study ID Numbers: |
2016CXGC07 2016-I2M-1-006 ( Other Grant/Funding Number: CAMS Innovation Fund for Medical Sciences ) |
| First Posted: | January 10, 2017 Key Record Dates |
| Last Update Posted: | July 28, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Within 3 years after the trial complete |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Within 3 years after the trial complete |
| Access Criteria: | To share IPD in the magazine of paper published |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Blood pressure control |
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Essential Hypertension Hypertension Vascular Diseases Cardiovascular Diseases |