EUCTR2014-003702-33-GB进行中（未招募）不适用
IMPRESS-AF: IMproved exercise tolerance in patients with PReserved Ejection fraction by Spironolactone on myocardial fibrosiS in Atrial Fibrillation - IMPRESS-AF trial, version 1.0
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Eligible study patients will be
- •Age 50 years old or over
- •Permanent AF as defined by the European Society of Cardiology (ESC) criteria
- •Normal BNP levels (<100 pg/mL)
- •Ability to understand and complete questionnaires (with or without use of a
- •translater/translated materials).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
排除标准
- •Severe systemic illness with life expectancy of less than 2 years from
- •Left ventricular ejection fraction (LVEF) <50% (echocardiography)
- •Severe chronic obstructive pulmonary disease (COPD) (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)
- •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
- •Any participant characteristic that may interfere with adherence to the
- •trial protocol
研究者
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