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NCT Number: NCT05991700

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.

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Key information

Conditions

Post-operative Atrial Fibrillation (POAF)

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Michigan - Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Catherine Wagner, MD

PRINCIPAL_INVESTIGATOR

China Green, BS

CONTACT

[email protected]

734-936-7731

Steven F Bolling, MD

PRINCIPAL_INVESTIGATOR

About this study

Voluntary recruitment hold pending approval of new protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Freeze-Dried California Table Grape

Drug

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

Placebo

Drug

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

Primary outcomes

  1. POAF-related events during initial hospital stay and within 30 days after surgery

    Time frame: 30 days

  2. Atrial transcripts related to NFκB activation; Impact on NIDDM, Angiotensin II

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

China Green, BS

CONTACT

[email protected]

734-936-7731

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • California Table Grape Commission

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 15, 2023
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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