Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Treatments: Hydrochlorothiazide; Olmesartan Medoxomil

Criteria

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.