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NCT05564780 | Not yet recruiting | Cardiovascular Diseases

Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension
Sponsor:

Chinese Academy of Medical Sciences, Fuwai Hospital

Information provided by (Responsible Party):

Jun CAI

Brief Summary:

STEP-Pre is to investigate the benefits of using anti-hypertensive drugs in the population with a blood pressure of 130-139/80-89 mmHg and evaluate the health economics. STEP-Pre is a multi-center randomized clinical trial. The cohort will be randomized into the treatment group or control group with a 1:1 ratio. The treatment group will take anti-hypertensive medicine to control blood pressure under 130/80 mmHg. Both groups will take health care education. STEP-Pre will last 4 years.

Condition or disease

Cardiovascular Diseases

Intervention/treatment

RASI and/or a single pill combination based RASI

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 20000 participants
Masking : Single
Primary Purpose : Prevention
Official Title : Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026
Arm Intervention/treatment

Experimental: Treatment

Antihypertensive drugs will be provided to the participants in the arm, including RASI and/or a single pill combination based on RASI. If the blood pressure of a participant elevates to above 140/90 mmHg, antihypertensive therapy will be provided.

No Intervention: Control

If the blood pressure of a participant elevates to above 140/90 mmHg, antihypertensive therapy will be provided.
Ages Eligible for Study: 35 Years to 64 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Stage 1 hypertension (blood pressure is in 130-139/80-89 mmHg);
  • 35 - 64 years old
  • Without taking antihypertensive medicine during screening
  • Signed the written informed consent
Exclusion Criteria
  • took antihypertensive medicine within the last 1 month;
  • History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack [TIA]);
  • History of myocardial infarction or unstable angina or history of coronary revascularization (PCI or CABG);
  • Lab tests indicating abnormal liver or kidney function (ALT ≥ 3 times the upper limit of normal value, or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2);
  • History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure；
  • 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;
  • Severe somatic disease such as cancer;
  • Severe cognitive impairment or mental disorders;
  • pregnant or breastfeeding, or planning to be pregnant;
  • having organ transplantation;
  • Participating in other clinical trials.
Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension

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Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension

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