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

NCT ID: NCT05991700

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-01-31

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

Voluntary recruitment hold pending approval of new protocol.

Conditions

Post-operative Atrial Fibrillation (POAF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Concentrated grape powder

Group Type: EXPERIMENTAL

Freeze-Dried California Table Grape

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Freeze-Dried California Table Grape

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Table Grape Commission

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Steven Bolling

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan - Michigan Medicine

Ann Arbor, Michigan, United States

Countries

United States

Central Contacts

China Green, BS

Role: CONTACT

chjgreen@med.umich.edu

734-936-7731

Facility Contacts

China Green, BS

Role: primary

chjgreen@med.umich.edu

734-936-7731

Other Identifiers

HUM00211419

Identifier Type: -

Identifier Source: org_study_id