NCT00417222已完成3 期
Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,145
- 试验地点
- 1
- 主要终点
- A composite of the following outcomes 1) all-cause death 2) nonfatal acute myocardial infarction 3) nonfatal stroke 4) hospital admission due to congestive heart failure
研究概览
简要总结
The purpose of this study is to investigate whether an angiotensin II receptor blocker (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity in hypertensive patients with stable chronic heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all of the following criteria.
- •Patients with NYHA class II through IV chronic heart failure.
- •Patients who have a history of hypertension or those who have antihypertensive medications.
- •Patients who are aged 20 years or older and less than 80 years at the entry.
- •Stable patients who have angiotensin converting enzyme inhibitor and/or beta-blocker.
- •Patients who do not have angiotensin II receptor blocker.
排除标准
- •Patients who have renal dysfunction (serum creatinine >=3.0mg/dL) or those who are receiving chronic hemodialysis.
- •History of drug hypersensitivity to olmesartan.
- •Patients who have severe liver dysfunction.
- •History of angioedema.
- •History of malignant tumor or life-threatening illness of poor prognosis.
- •Pregnant or possibly pregnant patients.
- •Cardiovascular surgery within 6months prior to the date of the entry.
- •Acute myocardial infarction within 6 months prior to the date of the entry.
- •Percutaneous coronary intervention or stent implantation within 6 months prior to the date of the entry.
- •Other patients deemed unsuitable as subjects of the study by the treating physician.
研究组 & 干预措施
Olmesartan medoxomil
Active Comparator
olmesartan medoxomil
干预措施: olmesartan medoxomil (Drug)
结局指标
主要结局
A composite of the following outcomes 1) all-cause death 2) nonfatal acute myocardial infarction 3) nonfatal stroke 4) hospital admission due to congestive heart failure
时间窗: by the end of the study
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
次要结局
- stroke(by the end of the study)
- cardiovascular death(by the end of the study)
- death due to heart failure(by the end of the study)
- sudden death(by the end of the study)
- acute myocardial infarction(by the end of the study)
- hospital admission from any cardiovascular reasons(by the end of the study)
- fatal arrhythmia or appropriate ICD discharge(by the end of the study)
- new-onset diabetes(by the end of the study)
- development of renal failure(by the end of the study)
- new-onset atrial fibrillation(by the end of the study)
- a need to modify treatment procedures for heart failure(by the end of the study)
- left ventricular ejection fraction(by the end of the study)
- B-type natriuretic peptide(by the end of the study)
研究者
Hiroaki Shimokawa, MD, PhD
Professor
Tohoku University
研究点 (1)
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