Improved Exercise Tolerance in Participants With PReserved Ejection Fraction by Spironolactone on Myocardial Fibrosis in Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Exercise tolerance (cardiopulmonary exercise testing)
研究概览
简要总结
This study aims to assess whether treatment with a drug called spironolactone, which is an aldosterone inhibitor, can improve ability to cope with exertion, quality of life and ability of the heart to relax better in symptomatic patients with atrial fibrillation with preserved pumping capacity.
详细描述
IMPRESS-AF study is a double-blinded randomised placebo-controlled trial of 2-year treatment with an aldosterone antagonist, spironolactone (25mg once daily) vs placebo in 250 patients with symptomatic chronic atrial fibrillation and preserved left ventricular contractility (both added to the current optimised care). The trial will establish impact of spironolactone on the primary outcome of exercise tolerance (peak oxygen consumption on cardiopulmonary exercise testing) and secondary outcomes: (i) health-related quality of life (assessed using the validated Minnesota Living with Heart Failure and EuroQol EQ-5D questionnaires self-completed by patients), and (ii) left ventricular diastolic function (E/e' ratio on echocardiography) - all assessed at baseline and at 2 years; (iii) rates of all-cause hospitalisations during 2-year follow-up.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanent AF
- •Left ventricular ejection fraction >= 55% as established by echocardiography
- •Able to perform cardio-pulmonary exercise testing using a cycling ergometer and complete quality of life questionnaires in English or in their native language.
排除标准
- •Severe systemic illness (life expectancy <2 years)
- •Severe chronic obstructive pulmonary disease (e.g., requiring home oxygen or chronic oral steroid therapy)
- •Severe mitral/aortal valve stenosis/regurgitation
- •Significant renal dysfunction (serum creatinine 220 µmol/L or above), anuria, active renal insufficiency, rapidly progressing or severe impairment of renal function, confirmed or suspected renal insufficiency in diabetic patients/ diabetic nephropathy
- •Increase in potassium level to >5mmol/L
- •Recent coronary artery bypass graft surgery (within 3 months)
- •Use of aldosterone antagonist within 14 days before randomisation
- •Use of or potassium sparing diuretic within 14 days before randomisation
- •Systolic blood pressure >160 mm Hg
- •Addison's disease
- •Hypersensitivity to spironolactone or any of the ingredients in the product
- •Any participant characteristic that may interfere with adherence to the trial protocol
研究组 & 干预措施
Spironolactone
Spironolactone 25 mg once daily for 2 years
干预措施: Spironolactone (Drug)
Placebo
Matched placebo once daily for 2 years
干预措施: Placebo (Drug)
结局指标
主要结局
Exercise tolerance (cardiopulmonary exercise testing)
时间窗: 2 years of treatment
Improvement in exercise tolerance (assessed using peak oxygen consumption on cardiopulmonary exercise testing)
次要结局
- Quality of life (MLWHF)(2 years of treatment)
- Quality of life (EQ-5D)(2 years of treatment)
- Rates of all-cause hospitalisations(2 years of treatment)
- Left ventricular diastolic function(2 years of treatment)
- Exercise tolerance (6-minute walk test)(2 years of treatment)
- Spontaneous return to sinus rhythm on electrocardiogram(2 years of treatment)