Study of Antihypertensive Treatment and Cardiovascular Risk in Chinese Prehypertensive Population
I. Research Objectives
Primary Objectives:
To evaluate the effect of low-dose antihypertensive therapy on the incidence of new-onset hypertension and new-onset diabetes in individuals with high-normal blood pressure and cardiovascular risk factors.
To assess the impact of low-dose antihypertensive therapy on composite cardiovascular events in individuals with high-normal blood pressure and cardiovascular risk factors.
Secondary Objective:
To evaluate the effects of low-dose antihypertensive therapy and different drug regimens on intermediate markers or subclinical status of cardiovascular disease risk, including lipid profiles, carotid atherosclerosis, and arterial stiffness (pulse wave velocity).
II. Study Population Individuals with high-normal blood pressure and comorbid cardiovascular risk factors who have not been treated with antihypertensive medications.
III. Endpoints
Primary Endpoints:
New-onset hypertension and new-onset diabetes. Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).
Other Endpoints:
Hospitalization for transient ischemic attack (TIA), hospitalization for angina pectoris, hospitalization for heart failure, peripheral vascular disease, malignancy, all-cause mortality, and renal failure.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Shandong
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Jinan, Shandong, 중국, 250000
- Qilu Hospital of Shandong University
-
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age: 50-79 years, regardless of sex.
- Blood Pressure: Systolic blood pressure (SBP) 130 ≤ SBP < 140 mmHg and/or diastolic blood pressure (DBP) 85 ≤ DBP < 90 mmHg.
- Presence of at least one cardiovascular risk factor.
- Capacity to provide informed consent.
Exclusion Criteria:
- Diabetes mellitus (FPG ≥ 7.0 mmol/L and/or OGTT 2h PG ≥ 11.1 mmol/L).
- Hypertension (SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg) or current use of antihypertensive medication.
- Participation in another clinical trial within 3 months prior to enrollment or concurrently with this study.
- Significant renal impairment (serum creatinine ≥ 2.5 mg/dL).
- Significant hepatic dysfunction (ALT > 2 × upper limit of normal [ULN]).
- Serum potassium < 3.5 mmol/L or > 5.6 mmol/L.
- Known hypersensitivity to the investigational drugs used in this study.
- History of stroke or myocardial infarction within 3 months prior to study entry.
- Undergoing or scheduled for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to study start.
- Other serious medical conditions (e.g., malignant tumors).
- Pregnant women or women of childbearing potential who are not using effective contraception or likely to become pregnant.
- Patients who are bedridden or unable to attend clinic visits.
- Any other condition requiring antihypertensive medication.
- Any indication or contraindication for the investigational drug or other antihypertensive agents.
- Subjects deemed unsuitable for inclusion by the investigator.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Placebo
Patients will receive a placebo, administered as half a tablet once daily.
|
Patients will receive a placebo, administered as half a tablet once daily.
|
|
실험적: Telmisartan
Patients will receive Telmisartan 40 mg, administered as one tablet once daily.
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Patients will receive Telmisartan 40 mg, administered as one tablet once daily.
|
|
실험적: Indapamide
Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.
|
Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).
기간: through study completion, an average of 4 year
|
Unit of Measure: Number and percentage of participants. |
through study completion, an average of 4 year
|
기타 결과 측정
결과 측정 |
기간 |
|---|---|
|
Hospitalization for transient ischemic attack (TIA), hospitalization for angina pectoris, hospitalization for heart failure, peripheral vascular disease, malignancy, all-cause mortality, and renal failure.
기간: through study completion, an average of 4 year
|
through study completion, an average of 4 year
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2006BAI01A03
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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