Anthocyanin-rich grape powder to prevent post-operative atrial fibrillation
Official title: Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Run by University of Michigan · NCT05991700 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | March 23, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT05991700 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Study coordinator: China Green, BS
- Email: chjgreen@med.umich.edu
- Phone: 734-936-7731
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Registry for patients with post-operative atrial fibrillation after cardiac surgery
This study is looking at how patients who develop irregular heartbeats after heart surgery are treated and what the standard care looks like.
-
Colchicine to lower inflammation and prevent atrial fibrillation after coronary bypass
This trial tests whether giving colchicine to adults having coronary artery bypass (CABG) can lower inflammation and reduce the chance of atrial fibrillation after surgery.
-
Preventing atrial fibrillation with surgical ablation and left atrial appendage clipping during heart surgery
This trial tests whether adding surgical ablation and clipping of the left atrial appendage during routine open-heart surgery can prevent postoperative and later atrial fibrillation in older patients at higher stroke risk.
-
Investigating Atrial Fibrillation After Heart Surgery
This study looks at how common irregular heartbeats are after heart surgery and what factors might increase the risk for patients in Thailand.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.