Anthocyanin-rich grape powder to prevent post-operative atrial fibrillation

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

We will test whether taking freeze-dried, anthocyanin-rich table grape powder before and after elective mitral valve surgery can reduce the chance of developing atrial fibrillation in adults aged 50–79 who are in normal sinus rhythm.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: University of Michigan (Academic / other)
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT05991700 on ClinicalTrials.gov

What this trial studies

This phase 1/2 interventional trial gives eligible patients either freeze-dried anthocyanin-rich California table grape powder or a placebo around the time of elective mitral valve repair to see if the supplement lowers postoperative atrial fibrillation (POAF). The protocol is placebo-controlled and designed to collect safety and tolerability data plus preliminary signals on POAF incidence and inflammatory gene transcription in blood and heart tissue. Eligible participants are adults aged 50–79 in sinus rhythm undergoing mitral valve repair without a Cox MAZE procedure, with standard exclusions to reduce confounding. Recruitment is currently on voluntary hold pending approval of a revised protocol.

Who should consider this trial

Good fit: Ideal candidates are adults 50–79 scheduled for elective mitral valve repair who are in preoperative sinus rhythm and do not have prior AF, prior cardiac surgery, active smoking, immunosuppression, or major structural/functional cardiac risk factors.

Not a fit: Patients with pre-existing atrial fibrillation, prior cardiac surgery or ablation, active inflammatory or infectious disease, immunosuppression, active smoking, very low ejection fraction, markedly enlarged left atrium, or age ≥80 are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, a well-tolerated, low-cost grape-derived supplement could lower rates of POAF and its downstream complications after cardiac surgery.

How similar studies have performed: Small trials of anti-inflammatory or transcription-modulating therapies have shown reduced POAF in some settings and early phytochemical studies indicate grape compounds can alter cardiac inflammatory gene expression, but using table-grape powder for POAF prevention is novel and early-stage.

Eligibility 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).

Where this trial is running

Ann Arbor, Michigan

• University of Michigan - Michigan Medicine — Ann Arbor, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: China Green, BS

Conditions Post-operative Atrial Fibrillation