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

NCT05564780 | Not Yet Recruiting

• 1 other identifier: 2022-GSP-GG-5
• Study Type: interventional
• Target: 20,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases

Keywords

Stage 1 Hypertension

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Disease

  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), and death from cardiovascular causes.

  4 years

Secondary Outcomes (4)

• Stroke ( ischemic or hemorrhagic)

  4 years

• Acute coronary syndrome

  4 Years

• CVD Death

  4 Years

• Advanced to Stage 2 Hypertension

  4 Years

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Drug: RASI and/or a single pill combination based RASI

Control

NO INTERVENTION

If the blood pressure of a participant elevates to above 140/90 mmHg, antihypertensive therapy will be provided.

Interventions

RASI and/or a single pill combination based RASI DRUG

The participants in the Treatment group will begin with a single category antihypertensive drug to control their blood pressure, for example, perindopril. If the blood pressure cannot be controlled under 130/80 mmHg, another type of antihypertensive drug will be added.

Treatment

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Stage 1 hypertension (blood pressure is in 130-139/80-89 mmHg);
• years old
• Without taking antihypertensive medicine during screening
• Signed the written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Central Study Contacts

Jun Cai, MD, PhD

CONTACT

13810615602; caijun7879@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP