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

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05991700

Collaborator

California Table Grape Commission (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Atrial Fibrillation (POAF)	Drug: Freeze-Dried California Table Grape Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Concentrated grape powder	Drug: Freeze-Dried California Table Grape Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery
Placebo Comparator: Placebo	Drug: Placebo Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery

Arm

Intervention/Treatment

Experimental: Concentrated grape powder

Drug: Freeze-Dried California Table Grape

Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery

Placebo Comparator: Placebo

Drug: Placebo

Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery

Outcome Measures

Primary Outcome Measures

POAF-related events during initial hospital stay and within 30 days after surgery [30 days]
Atrial transcripts related to NFκB activation; Impact on NIDDM, Angiotensin II [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan - Michigan Medicine	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan
California Table Grape Commission

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Catherine Wagner, House Officer, University of Michigan

ClinicalTrials.gov Identifier:

NCT05991700

Other Study ID Numbers:

HUM00211419

First Posted:

Aug 15, 2023

Last Update Posted:

Aug 15, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Aug 15, 2023