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

NCT05991700 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HUM00211419
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Atrial Fibrillation (POAF)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Concentrated grape powder

EXPERIMENTAL

Drug: Freeze-Dried California Table Grape

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Freeze-Dried California Table Grape DRUG

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

Concentrated grape powder

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Michigan: lead
• California Table Grape Commission: collaborator

Study Sites (1)

University of Michigan - Michigan Medicine

Ann Arbor, Michigan, 48109, United States

RECRUITING

Central Study Contacts

China Green, BS

CONTACT

734-936-7731; chjgreen@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: March 23, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)