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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Age ≥ 80 years

Diagnosed pre-operative chronic or paroxysmal AF

Prior ablation procedure for AF

Previous cardiac surgery

Trial design

Treatments tested in this trial

  • Freeze-Dried California Table Grape
  • Placebo

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Michigan

Lead sponsor

California Table Grape Commission

Collaborator