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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post-operative Atrial Fibrillation (POAF)

Intervention / Treatment
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* Drug: Freeze-Dried California Table Grape
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concentrated grape powder<br> | Drug: Freeze-Dried California Table Grape<br>* Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POAF-related events during initial hospital stay and within 30 days after surgery |  | 30 days | 
| Atrial transcripts related to NFκB activation; Impact on NIDDM, Angiotensin II |  | 30 days |