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

Post-operative Atrial Fibrillation (POAF) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05991700
• Other study ID #: HUM00211419
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2024
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: China Green, BS
• Phone: 734-936-7731
• Email: chjgreen[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Post-operative Atrial Fibrillation (POAF)

Intervention

Drug:
• Freeze-Dried California Table Grape
Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery
• Placebo
Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery

Locations

Country	Name	City	State
United States	University of Michigan - Michigan Medicine	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	California Table Grape Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POAF-related events during initial hospital stay and within 30 days after surgery		30 days
Primary	Atrial transcripts related to NF?B activation; Impact on NIDDM, Angiotensin II		30 days