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NCT05991700 | RECRUITING | Post-operative Atrial Fibrillation (POAF)

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

University of Michigan

Information provided by (Responsible Party):

Steven Bolling

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.

Condition or disease

Post-operative Atrial Fibrillation (POAF)

Intervention/treatment

Freeze-Dried California Table Grape

Placebo

Phase

PHASE1

PHASE2

Detailed Description:

Voluntary recruitment hold pending approval of new protocol.

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : SINGLE
Primary Purpose : PREVENTION
Official Title : Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Actual Study Start Date : 2026-04
Estimated Primary Completion Date : 2027-08
Estimated Study Completion Date : 2027-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 79 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).
Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation

Location Details

NCT05991700

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Locations

RECRUITING

United States, road cancer

University of Michigan - Michigan Medicine

Ann Arbor, road cancer, United States, 48109