Recruiting
Phase 1
Phase 2

Concentrated Grape Powder

Sponsor:

University of Michigan

Code:

NCT05991700

Conditions

Post-operative Atrial Fibrillation (POAF)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Freeze-Dried California Table Grape

Placebo

Study Details

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)

Study ID

NCT05991700

Start date

Mar 23, 2026

Status verified date

Apr, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Concentrated grape powder

placebo comparator: Placebo

Interventions

Freeze-Dried California Table Grape

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

Placebo

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

Primary outcome measure

  • POAF-related events during initial hospital stay and within 30 days after surgery [ Time Frame: 30 days ]
  • Atrial transcripts related to NFκB activation; Impact on NIDDM, Angiotensin II [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan - Michigan Medicine

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Steven F Bolling, MD

More Information

Sponsor

University of Michigan

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-04-27.