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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan - Michigan MedicineAnn ArborMichigan48109
China Green, BS
734-936-7731
Steven F Bolling, MD (PRINCIPAL_INVESTIGATOR)
Catherine Wagner, MD (PRINCIPAL_INVESTIGATOR)

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