Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- exercise capacity and aortic distensibility
研究概览
简要总结
BACKGROUND: Exercise intolerance is the primary symptom in older patients with heart failure and preserved ejection fraction (HFPEF), however little is known regarding its mechanisms and therapy.
METHODS: 71 elderly stable, compensated HFPEF patients (age 70+1 years; 80% women) with controlled blood pressure were randomized into a 12 month follow-up (FU) double-blind trial of enalapril 20 mg per day (E) vs. placebo (P). Assessments included: peak exercise oxygen consumption (VO2); six-minute walk test; Minnesota Living with HF Questionnaire (MLHF); MRI; Doppler-echocardiography; and vascular ultrasound.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All participants will be 60 years of age or older.
排除标准
- •systolic dysfunction
- •patients with evidence of significant ischemic or valvular heart disease
- •chronic pulmonary disease.
- •Participants who appear preliminarily eligible are invited to a formal screening visiting with an investigator cardiology physician. They also undergoing a rest and exercise electrocardiogram and echocardiogram and pulmonary function testing as well as blood hematology and chemistry tests.
- •Final eligibility will be based upon all information available at the conclusion of the screening visits test, including hospital and outpatient records, history, physical examination, echocardiogram and exercise test.
研究组 & 干预措施
Enalapril
2.5mg titrated up to 10mg- twice daily
干预措施: Enalapril (Drug)
placebo
2.5 mg titrate up to 10mg twice daily placebo comparator
干预措施: placebo (Drug)
结局指标
主要结局
exercise capacity and aortic distensibility
时间窗: 9 months
MRI and expired gas analysis
次要结局
未报告次要终点