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Recruiting Phase 1, Phase 2 NCT05991700

Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation

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Trial Parameters

Condition Post-operative Atrial Fibrillation (POAF)
Sponsor University of Michigan
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age 79 Years
Start Date 2026-04
Completion 2027-08
Interventions
Freeze-Dried California Table GrapePlacebo

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Brief 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 phytochemicals, such as those found in grapes, have excellent bioavailability and can affect cardiac gene transcription related to inflammation. In this study, we propose to evaluate the efficacy of preoperative administration of concentrated grape powder in the prevention of POAF.

Eligibility Criteria

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 low ejection fraction (EF) (EF\<50%), left atrial (LA) dilation (LA\>5.0 cm), and high degree of mitral regurgitation (grade 3-4).

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