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Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension (STEP-Pre)

Primary Purpose

Cardiovascular Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RASI and/or a single pill combination based RASI
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Stage 1 Hypertension

Eligibility Criteria

35 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment

    Control

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Stroke ( ischemic or hemorrhagic)
    Stroke is defined as a rapid onset of focal (or global) disturbance of cerebral function lasting more than 24 hours (except interrupted by surgery or death) without resolution of symptoms according to the World Health Organization. The diagnosis of stroke is confirmed by strict neurological examination, computed tomography (CT), or magnetic resonance imaging (MRI), and stroke subtypes are classified including ischemic or hemorrhagic, fatal or not fatal.
    Acute coronary syndrome
    Acute coronary syndrome includes myocardial infarction and hospitalization for unstable angina. The diagnosis of MI is based on the following criteria: (1) Patient has cardiac signs and symptoms, such as retrosternal pain last for at least 30 minutes, and not relieve to nitroglycerine during the attack; (2) Electrocardiographic abnormal findings of MI are observed; (3) Biochemical markers of cardiac damage are present. The diagnosis of unstable angina requires hospitalization for evaluation. The clinical presentation of unstable angina includes: (1) prolonged (>20 min) angina pain at rest; (2) new onset angina; (3) post-MI angina; (4) recent destabilization of previously stable angina with at least Canadian Cardiovascular Society Class III angina characteristics.
    CVD Death
    Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death.
    Advanced to Stage 2 Hypertension
    the proportion of participants with blood pressure increasing to above 140/90 mmHg.

    Full Information

    First Posted
    September 29, 2022
    Last Updated
    September 29, 2022
    Sponsor
    Chinese Academy of Medical Sciences, Fuwai Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05564780
    Brief Title
    Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension
    Acronym
    STEP-Pre
    Official Title
    Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2026 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese Academy of Medical Sciences, Fuwai Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases
    Keywords
    Stage 1 Hypertension

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    If the blood pressure of a participant elevates to above 140/90 mmHg, antihypertensive therapy will be provided.
    Intervention Type
    Drug
    Intervention Name(s)
    RASI and/or a single pill combination based RASI
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Cardiovascular Disease
    Description
    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.
    Time Frame
    4 years
    Secondary Outcome Measure Information:
    Title
    Stroke ( ischemic or hemorrhagic)
    Description
    Stroke is defined as a rapid onset of focal (or global) disturbance of cerebral function lasting more than 24 hours (except interrupted by surgery or death) without resolution of symptoms according to the World Health Organization. The diagnosis of stroke is confirmed by strict neurological examination, computed tomography (CT), or magnetic resonance imaging (MRI), and stroke subtypes are classified including ischemic or hemorrhagic, fatal or not fatal.
    Time Frame
    4 years
    Title
    Acute coronary syndrome
    Description
    Acute coronary syndrome includes myocardial infarction and hospitalization for unstable angina. The diagnosis of MI is based on the following criteria: (1) Patient has cardiac signs and symptoms, such as retrosternal pain last for at least 30 minutes, and not relieve to nitroglycerine during the attack; (2) Electrocardiographic abnormal findings of MI are observed; (3) Biochemical markers of cardiac damage are present. The diagnosis of unstable angina requires hospitalization for evaluation. The clinical presentation of unstable angina includes: (1) prolonged (>20 min) angina pain at rest; (2) new onset angina; (3) post-MI angina; (4) recent destabilization of previously stable angina with at least Canadian Cardiovascular Society Class III angina characteristics.
    Time Frame
    4 Years
    Title
    CVD Death
    Description
    Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death.
    Time Frame
    4 Years
    Title
    Advanced to Stage 2 Hypertension
    Description
    the proportion of participants with blood pressure increasing to above 140/90 mmHg.
    Time Frame
    4 Years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Cai, MD, PhD
    Phone
    13810615602
    Email
    caijun7879@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The collected data, study protocol, and SAP are planned to be shared after the study ends 5 years later.

    Learn more about this trial

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

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