Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02673463
Status:
UNKNOWN
Last Update Posted:
2018-10-11
First Post:
2016-02-01
Brief Title:
Spironolactone in Atrial Fibrillation
Sponsor:
University of Birmingham
Organization:
University of Birmingham
Study Overview
Official Title:
Improved Exercise Tolerance in Participants With PReserved Ejection Fraction by Spironolactone on Myocardial Fibrosis in Atrial Fibrillation
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPRESS-AF
Brief Summary:
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
Detailed Description:
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 Ee ratio on echocardiography - all assessed at baseline and at 2 years iii rates of all-cause hospitalisations during 2-year follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None