Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan
- Study ID
- NCT05991700
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Post-operative Atrial Fibrillation (POAF)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 79 Years
- Healthy Volunteers
- Not accepted
Interventions
- Freeze-Dried California Table Grape — DRUGConsume 2 servings (30.66g/serving) per day for three days before cardiac surgery
- Placebo — DRUGConsume 2 servings (30.66g/serving) per day for three days before cardiac surgery
Study Details
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.
Key Dates
- Start date
- Mar 23, 2026
- Status verified
- Apr 2026
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 70 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Concentrated grape powder
- Placebo Comparator: Placebo
Primary Outcome Measure
POAF-related events during initial hospital stay and within 30 days after surgery [ Time Frame: 30 days ]
Central Contacts
- China Green, BS734-936-7731
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan - Michigan Medicine | Ann Arbor | Michigan | 48109 | Steven F Bolling, MD (PRINCIPAL_INVESTIGATOR) Catherine Wagner, MD (PRINCIPAL_INVESTIGATOR) |