IMPRESS-AF: Improved exercise tolerance in heart failure with preserved ejection fraction by spironolactone on myocardial fibrosis in atrial fibrillation

IMPRESS-AF: IMproved exercise tolerance in heart failure with PReserved Ejection fraction by Spironolactone on myocardial fibrosiS in Atrial Fibrillation - an open randomised double-blind parallel-group trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10259346

Enrollment

250

Registered

2015-01-15

Start date

2015-01-01

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of symptomatic patients with atrial fibrillation with preserved ejection fraction Circulatory System Atrial fibrillation and flutter

Interventions

The study patients will be randomised to receive spironolactone or placebo (i.e., two-arm study). Study patients and researchers will be blinded to treatment allocation. Placebo and spironolactone wil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 50 years old or over 2. Permanent AF as defined by the European Society of Cardiology (ESC) criteria 3. Normal BNP levels (<100 pg/mL) 4. Ability to understand and complete questionnaires (with or without use of a translator/translated materials)

Exclusion criteria

Exclusion criteria: 1. Severe systemic illness with life expectancy of less than 2 years from screening 2. Left ventricular ejection fraction (LVEF) 5mmol/L) 7. Recent coronary artery bypass graft surgery (within 3 months) 8. Use of aldosterone antagonist within 14 days before randomisation 9. Use of or potassium sparing diuretic within 14 days before randomisation 10. Systolic blood pressure >160 mm Hg 11. Addison’s disease 12. Hypersensitivity to spironolactone or any of the ingredients in the product 13. Any participant characteristic that may interfere with adherence to the trial protocol

Design outcomes

Primary

Measure	Time frame
Exercise tolerance (peak VO2 on cardio-pulmonary exercise testing); Timepoint(s): 2 years of treatment	—

Secondary

Measure	Time frame
1. Diastolic function measured by echocardiography; Timepoint(s): After 2 years of treatment 2. Exercise tolerance measured by 6-minute walking test; Timepoint(s): 2 years of treatment 3. Health-related quality of life (assessed using the validated questionnaires); Timepoint(s): After 2 years of treatment 4. Rates of all-cause hospitalisations; Timepoint(s): After 2 years of treatment 5. Sinus rhythm; Timepoint(s): After 2 years of treatment	—

Measure

Time frame

1. Diastolic function measured by echocardiography; Timepoint(s): After 2 years of treatment 2. Exercise tolerance measured by 6-minute walking test; Timepoint(s): 2 years of treatment 3. Health-related quality of life (assessed using the validated questionnaires); Timepoint(s): After 2 years of treatment 4. Rates of all-cause hospitalisations; Timepoint(s): After 2 years of treatment 5. Sinus rhythm; Timepoint(s): After 2 years of treatment

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026