At a glance
ClinicalIndex Comparison Record- ✓Undergoing elective valvular heart surgery or coronary artery bypass grafting (CABG)
- ✕History of atrial fibrillation other than remote paroxysmal AF
- ✕Ejection fraction less than 30%
- ✕Evidence of coagulopathy (INR >1.7 without warfarin)
- ✕Emergency surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
RAAS, Inflammation, and Post-operative AF
In Brief
A Phase 3 clinical trial evaluating Placebo, Ramipril, and 1 other intervention for Atrial Fibrillation. Completed, enrolled 455 participants across 1 site.
Detailed Summary
Atrial fibrillation (AF) is the most prevalent, sustained type of irregular heartbeat and affects over 2 million Americans. Post-operative AF, which leads to significant morbidity and a prolonged hospital stay, complicates 20% to 40% of cardiopulmonary bypass (CPB) surgical procedures. While recent studies indicate that interruption of the renin-angiotensin-aldosterone system by either angiotensin-converting enzyme (ACE) inhibition or AT1 receptor antagonism decreases the incidence of AF following a heart attack or cardioversion (electric shock to the heart), its effect on the incidence of post-operative AF has not been throughly studied. Studies in both animals and humans suggest that inflammation-induced atrial remodeling plays an important role in the cause of AF. Recent studies also provide evidence that activation of the renin-angiotensin-aldosterone system induces inflammation, myocyte injury, proarrhythmic electrical remodeling, and fibrosis through aldosterone.
Study Details
Timeline
Interventions
Matching placebo taken once a day
Taken orally, once a day
Taken orally, once a day