NCT05564780Not yet recruiting
Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension
Source: ClinicalTrials.gov · Last updated 4 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20000 (estimated)
- First submitted
- 29 Sept 2022
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Diseases
- High blood pressure
- NCT number
- NCT05564780
What you commit to
- Study type: Interventional
- Planned participants: 20000
- From 1 Jan 2023 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- having organ transplantation;
Other illness
- 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);
- 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;
Lab values
- 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);
Other
- took antihypertensive medicine within the last 1 month;
- pregnant or breastfeeding, or planning to be pregnant;
- Participating in other clinical trials.
Who the study is looking for
- 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
Age in the registry: 35 years to 64 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.