Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Unknown

Conditions: Primary Hypertension

Treatments: Drug: Intensive BP control; Drug: Standard BP control

Study type: Interventional

Funder types: Other

Identifiers

NCT03015311

2016CXGC07

2016-I2M-1-006 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Systolic BP between 140-190 mm Hg in the three screening visits or currently under anti-hypertension treatment；
2. An age of 60 - 80 years old；
3. Signed the written informed consent.

Exclusion criteria

1. Systolic BP≥190 mm Hg, or diastolic BP <60 mm Hg;
2. Known secondary cause of hypertension;
3. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack [TIA]);
4. Hospitalization for myocardial infarction or unstable angina within the previous 6 months;
5. Coronary revascularization (PCI or CABG) within the previous 12 months;
6. Planned to perform coronary revascularization (PCI or CABG) in the future 12 months;
7. History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure；
8. NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months;
9. Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial;
10. Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease;
11. Uncontrolled diabetes (serum fasting glucose ≥200 mg/dl [11.1 mmol/L], HbA1>8%);
12. 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];
13. Severe somatic disease such as cancer;
14. Severe cognitive impairment or mental disorders;
15. Participating in other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8,000 participants in 2 patient groups

Intensive BP control

Experimental group

Description:

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

Treatment:

Drug: Intensive BP control

Standard BP control

Active Comparator group

Description:

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

Treatment:

Drug: Standard BP control