Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery and leads to worse outcomes. POAF is thought to be caused by the inflammatory state following cardiac surgery. It may be that anti-inflammatory medications could lower the occurrence of POAF, however many typical anti-inflammato
| Condition(s) | Post-operative Atrial Fibrillation (POAF) |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery and leads to worse outcomes. POAF is thought to be caused by the inflammatory state following cardiac surgery. It may be that anti-inflammatory medications could lower the occurrence of POAF, however many typical anti-inflammatory medications, such as ibuprofen, are contraindicated in the post cardiac surgery patient due to increased risks of bleeding. If a drug was identified with anti-inflammatory properties with minimal deleterious side effects, this could be broadly applied to cardiac surgery patients for the prevention of POAF. Interestingly, several small trials have shown that medications that alter transcription of inflammatory markers lead to decreased POAF. Furthermore, we have shown that |
| Who can participate | Inclusion Criteria: * Males and female patients (age 50-79) at the Mitral Valve Clinic/CVC undergoing elective cardiac surgery for mitral valve repair without the Cox MAZE procedure (MVR patients also undergoing CABG and/or tricuspid valve repair are also eligible) * In sinus rhythm (no pre-operative atrial fibrillation) Exclusion Criteria: * Age ≥ 80 years * Diagnosed pre-operative chronic or paroxysmal AF * Prior ablation procedure for AF * Previous cardiac surgery * Implanted pacemaker * Active smoker * Comorbidities such as congenital or cardiac re-operation * Use of antiarrhythmic agents * Active inflammatory or infectious disease or malignancy * Diagnosed autoimmune disease * Corticosteroid or other immunomodulatory or immunosuppressive medication * Risk factors for POAF including lo |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Lead sponsor | University of Michigan |
| Locations | Ann Arbor, Michigan, United States |
| Start date | 2026-03-23 |
| NCT ID | NCT05991700 |
| Official listing | https://clinicaltrials.gov/study/NCT05991700 |