Exercise Intolerance in Elderly Diastolic Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire-total Score
研究概览
简要总结
The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).
详细描述
Exercise intolerance due to HFPEF is a major cause of disability among older Americans. Several lines of evidence suggest that aldosterone antagonism may improve exercise tolerance in HFPEF. Therefore, the primary aim of this study is to test the hypothesis that spironolactone will improve exercise tolerance and quality of life in elderly patients with isolated HFPEF. A total of 72 participants aged 60 or older will be randomized to receive either spironolactone 25mg daily or a placebo.
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
- •Ambulatory
- •Medically stable
- •Ages 60 or older
- •Diagnosis of diastolic heart failure
排除标准
- •Valvular heart disease
- •Significant change in cardiac medication within the past 4 weeks
- •Uncontrolled hypertension
- •Recent or debilitating stroke
- •Cancer or other noncardiovascular conditions with life expectancy less than 2 years
- •Elevated serum potassium
- •Renal insufficiency
- •Psychiatric disease (uncontrolled major psychoses, depression, dementia, or personality disorder)
- •Allergy to spironolactone; currently taking spironolactone or any aldosterone antagonist
- •Plans to leave area within 1 year
- •Refuses informed consent
- •Failure to pass screening tests: pulmonary function, echocardiogram, or exercise
- •Contra-indications to magnetic resonance imaging [MRI] (indwelling metal-containing prosthesis; pacemaker or defibrillator; history of welding occupation; uncontrollable claustrophobia)
研究组 & 干预措施
1
Spironolactone
干预措施: Spironolactone (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire-total Score
时间窗: Baseline, 4 and 9 months
The Minnesota Living with Heart Failure Questionnaire (MLHF) is a self-administered disease-specific questionnaire for patients with Heart Failure, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score. Scale of 0-105:The higher the score the worse the heart failure related Quality of Life.
Exercise Intolerance
时间窗: Baseline, 4 and 9 months
Peak exercise VO2
次要结局
- Concentric Left Ventricular Remodeling(Baseline, 9 month)
- Left Ventricular Diastolic Stiffness(Baseline, 4 month and 9 month)