RecruitingPhase 1Phase 2NCT05991700

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


Sponsor

University of Michigan

Enrollment

70 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a grape powder supplement (rich in anthocyanins — natural antioxidants found in dark-colored fruits) can prevent an irregular heart rhythm called atrial fibrillation (AF) that sometimes happens after heart surgery. **You may be eligible if...** - You are between 50 and 79 years old - You are scheduled for elective heart surgery to repair the mitral valve (the valve between two chambers of your heart) - You are in a normal heart rhythm before surgery (no prior atrial fibrillation) **You may NOT be eligible if...** - You are 80 years or older - You already have a history of atrial fibrillation - You have previously had heart surgery or a cardiac ablation procedure - You have a pacemaker - You are having emergency (non-elective) heart surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFreeze-Dried California Table Grape

Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery

DRUGPlacebo

Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery


Locations(1)

University of Michigan - Michigan Medicine

Ann Arbor, Michigan, United States

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NCT05991700