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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Atrial Fibrillation (POAF)
• Intervention / Treatment: Drug: Freeze-Dried California Table Grape; Drug: Placebo

Detailed Description

Voluntary recruitment hold pending approval of new protocol.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: China Green, BS; Phone Number: 734-936-7731; Email: chjgreen@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan - Michigan Medicine
      • Principal Investigator: Steven F Bolling, MD
      • Contact: China Green, BS; Phone Number: 734-936-7731; Email: chjgreen@med.umich.edu
      • Principal Investigator: Catherine Wagner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery
Experimental: Concentrated grape powder	Drug: Freeze-Dried California Table Grape; Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: California Table Grape Commission

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: HUM00211419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No