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

University of Michigan

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Post-operative Atrial Fibrillation (POAF)

Treatments

Drug: Freeze-Dried California Table Grape

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05991700

HUM00211419

Details and patient eligibility

About

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.

Full description

Voluntary recruitment hold pending approval of new protocol.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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).