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

Primary Purpose

Post-operative Atrial Fibrillation (POAF)

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Freeze-Dried California Table Grape
Placebo
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-operative Atrial Fibrillation (POAF)

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • University of Michigan - Michigan Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Concentrated grape powder

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 7, 2023
Last Updated
August 7, 2023
Sponsor
University of Michigan
Collaborators
California Table Grape Commission
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1. Study Identification

Unique Protocol Identification Number
NCT05991700
Brief Title
Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Official Title
Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
California Table Grape Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Atrial Fibrillation (POAF)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concentrated grape powder
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Freeze-Dried California Table Grape
Intervention Description
Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Consume 2 servings (30.66g/serving) per day for three days before cardiac surgery
Primary Outcome Measure Information:
Title
POAF-related events during initial hospital stay and within 30 days after surgery
Time Frame
30 days
Title
Atrial transcripts related to NFκB activation; Impact on NIDDM, Angiotensin II
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
China Green, BS
Phone
734-936-7731
Email
chjgreen@med.umich.edu
Facility Information:
Facility Name
University of Michigan - Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
China Green, BS
Phone
734-936-7731
Email
chjgreen@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Steven F Bolling, MD
First Name & Middle Initial & Last Name & Degree
Catherine Wagner, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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