Key eligibility criteria for IMPRESS-AF
| Inclusion criteria | Exclusion criteria |
|---|---|
| Permanent AF | LVEF<55% (echocardiography) |
| Age 50 years old or over | Severe systemic illness (life expectancy <2 years) |
| Ability to understand and complete questionnaires (with or without use of a translater/translated materials) | Severe COPD (eg, 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 patients with diabetes/diabetic nephropathy | |
| Increase in potassium level to >5 mmol/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 |
AF, atrial fibrillation; COPD, chronic obstructive pulmonary disease; IMPRESS-AF, IMproved exercise tolerance In heart failure With PReserved Ejection fraction by Spironolactone On myocardial fibrosiS In Atrial; LVEF, left ventricular ejection fraction.