Actively Recruiting
Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Led by University of Michigan · Updated on 2026-04-27
70
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
C
California Table Grape Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 50 to 79 years undergoing elective mitral valve repair cardiac surgery without Cox MAZE procedure
- Patients in normal heart rhythm without pre-operative atrial fibrillation
- Patients at the Mitral Valve Clinic/CVC, including those also having CABG or tricuspid valve repair with mitral valve repair
You will not qualify if you...
- Age 80 years or older
- Diagnosed chronic or paroxysmal atrial fibrillation before surgery
- Previous atrial fibrillation ablation procedure
- Prior cardiac surgery
- Implanted pacemaker
- Active smoker
- Congenital heart disease or cardiac re-operation
- Use of antiarrhythmic medications
- Active inflammatory, infectious disease, or cancer
- Diagnosed autoimmune disease
- Use of corticosteroids or other immunomodulatory or immunosuppressive drugs
- Risk factors for POAF including low ejection fraction (less than 50%), left atrial dilation (greater than 5.0 cm), or severe mitral regurgitation (grade 3-4)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
China Green, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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