EUCTR2014-003702-33-GB
Active, not recruiting
Not Applicable
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
ConditionsAtrial fibrillation with preserved left ventricular systolic function and normal levels of the brain natriuretic peptide.MedDRA version: 18.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 18.0Level: LLTClassification code 10069211Term: Diastolic heart failureSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 18.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsSpironolactone
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial fibrillation with preserved left ventricular systolic function and normal levels of the brain natriuretic peptide.
- Sponsor
- niversity of Birmingham
- Enrollment
- 250
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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