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

StatusRecruiting
PhasePhase 1/2
Started2026-03-23
View on ClinicalTrials.gov ↗

Amendment history

2026-04-24
minor
Study Status v8
Start dateestimated 2026-04→confirmed 2026-03-23
2026-02-04
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-12→2027-08
Completion date2027-01→2027-08
Start date2025-09→2026-04
Study sitesdetails revised at 1 of 1 site
2025-07-09
minor
Study Status, Oversight, Study Description v6
Primary completion date2026-08→2026-12
Completion date2026-10→2027-01
Start date2025-05→2025-09
Study description+60 characters
Voluntary recruitment hold pending approval of new protocol.
2025-03-31
minor
Study Status, Contacts/Locations v5
Primary completion date2026-07→2026-08
Completion date2026-07→2026-10
Start date2025-02→2025-05
Study sitescontacts updated at 1 of 1 site
2025-01-08
minor
Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v4
Primary completion date2025-04→2026-07
Completion date2025-06→2026-07
Start date2024-07→2025-02
Study sitescontacts updated at 1 of 1 site
Show 3 earlier versions
2024-06-07
minor
Study Status v3
Start date2024-04→2024-07
2024-03-29
minor
Study Status v2
Primary completion date2025-01→2025-04
Completion date2025-03→2025-06
Start date2024-01→2024-04
2023-12-12
minor
Study Status v1
Primary completion date2024-09→2025-01
Completion date2024-12→2025-03
Start date2023-09→2024-01
2023-08-07
minor
Original filing
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.
Trial Details
NCT Number NCT05991700
Lead Sponsor University of Michigan
Collaborators: California Table Grape Commission
Conditions Post-operative Atrial Fibrillation (POAF)
Enrollment 70 participants
Start Date 2026-03-23
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-27