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

Phase 1

Not yet recruiting

• Conditions: Post-operative Atrial Fibrillation (POAF)
• Interventions: Drug: Placebo; Drug: Freeze-Dried California Table Grape

• Registration Number: NCT05991700
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Study Start: 2025-05
• Primary Completion: 2026-08
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Concentrated grape powder	Freeze-Dried California Table Grape	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Michigan - Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States