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

RecruitingPhase 1, Phase 2Ages 18 Years - 79 YearsAllUniversity of Michigan
NCT05991700 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Freeze-Dried California Table Grape
  • Placebo
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Where

1 site
University of Michigan - Michigan Medicine
Ann Arbor, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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