NCT05991700RecruitingPhase 1/2
Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 7 Aug 2023
- Start date
- 23 Mar 2026
- Primary completion date
- Aug 2027
- Lead sponsor
- University of Michigan
- Diseases
- Atrial fibrillation
- NCT number
- NCT05991700
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 70
- From 23 Mar 2026 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior ablation procedure for AF
- Previous cardiac surgery
- Corticosteroid or other immunomodulatory or immunosuppressive medication
Other illness
- Comorbidities such as congenital or cardiac re-operation
- Active inflammatory or infectious disease or malignancy
- Diagnosed autoimmune disease
Lab values
- 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).
Age
- Age ≥ 80 years
Other
- Diagnosed pre-operative chronic or paroxysmal AF
- Implanted pacemaker
- Active smoker
- Use of antiarrhythmic agents
Who the study is looking for
- 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)
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan - Michigan Medicine Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.