NCT00095238已完成3 期
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 4,128 人开始时间: 2002年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,128
- 试验地点
- 1
- 主要终点
- Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
研究概览
简要总结
The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age >= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV
- •Left ventricular ejection fraction (LVEF) > = 45%
- •Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease.
排除标准
- •Acute myocardial infarction within 3 months;
- •Heart revascularization procedure within 3 months;
- •Hospitalization for angina within 3 months;
- •Other heart surgery
- •Life-threatening or uncontrolled arrhythmia
- •Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months;
- •Stroke or surgery of the arteries in the brain within 3 months;
- •Serious lung disease which requires use of home oxygen.
- •Significantly low blood pressure
- •Significantly high blood pressure
- •Other known diseases that may limit life expectancy to <3 years;
- •Known or suspected bilateral kidney artery narrowing;
- •Geographic or social factors making study participation and follow-up impractical.
研究组 & 干预措施
1
Active Comparator
干预措施: Irbesartan (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
时间窗: Year 1, Year 2, Year 3, Year 4, Year 5
Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.
次要结局
- Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points(Year 1, Year 2, Year 3, Year 4, Year 5)
- Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit(Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.)
- Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline(Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.)
- Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints(Year 1, Year 2, Year 3, Year 4, Year 5)
- Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66(Baseline, Month 42, Month 54, Month 66)
- Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints(Year 1, Year 2, Year 3, Year 4, Year 5)
- Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14(Baseline, Month 6, Month 14)
- Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14(Baseline, Month 6, Month 14)
- Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints(Year 1, Year 2, Year 3, Year 4, Year 5)
- Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)(Baseline, Final Visit)
- Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints(Year 1, Year 2, Year 3, Year 4, Year 5)
- Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline(Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.)
- Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline(Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.)
- Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints(Year 1, Year 2, Year 3, Year 4, Year 5)
- Percentage of Participants Experiencing All-cause Death at Given Time Points(Year 1, Year 2, Year 3, Year 4, Year 5)
- Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit(Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.)
- Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline(Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.)
- Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30(Baseline, Month 6, Month 18, Month 30)
研究者
研究点 (1)
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