Back to resultsPilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence
Primary Purpose
Post-operative Atrial Fibrillation (POAF)
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tart cherry concentrate
Sponsored by
About this trial
This is an interventional prevention trial for Post-operative Atrial Fibrillation (POAF)
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, no hx of AF)
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
- Known sensitivity to sorbitol
- Known gastric sensitivity to acidic juices like orange juice
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tart Cherry Concentrate
Arm Description
Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Servings (1 ounce or 2 tablespoon/serving) per day for three days
Outcomes
Primary Outcome Measures
Patient-reported tolerability score
Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale
Efficacy as measured by total number of days in hospital within 60 days of surgery
Total number of days in hospital within 60 days of the index surgery
Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
Secondary Outcome Measures
Time to conversion to normal sinus rhythm
Perioperative time to conversion to normal sinus rhythm
Heart rhythm at hospital discharge
Heart rhythm at hospital discharge
Heart rhythm at 30 days
Heart rhythm at 30 days
Need for permanent pacemaker within 30 days of surgery
Need for permanent pacemaker within 30 days of surgery
Cerebrovascular thromboembolism [stroke, TIA]
Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA]
Non-cerebrovascular thromboembolism
Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism
Bleeding
Incidences (yes/no, total number) of Bleeding
Cerebrovascular events
Incidences (yes/no, total number) of Cerebrovascular events
Incidences of postoperative clinical events
Incidences (yes/no, total number) of Non-cerebrovascular events
Length of Hospital Stay
LOS [Index hospitalization]
Number of Re-hospitalization and ED visits
Number of Re-hospitalization and ED visits
Number of Outpatient Interventions
Number of Outpatient interventions
Total Costs for Hospital stay
Costs [incident hospital stay]
Full Information
NCT ID
NCT03793465
First Posted
January 2, 2019
Last Updated
July 18, 2023
Sponsor
University of Michigan
Collaborators
Cherry Marketing Institute, Dewitt MI (USA)
1. Study Identification
Unique Protocol Identification Number
NCT03793465
Brief Title
Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence
Official Title
Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Cherry Marketing Institute, Dewitt MI (USA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assess impact of Tart Cherry Concentrate in cardiac surgical patients on POAF and related clinical and economic outcomes. Measure inflammation gene transcripts in cardiac tissue.
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
Single Group Assignment
Model Description
Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Consumption - 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tart Cherry Concentrate
Arm Type
Experimental
Arm Description
Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Servings (1 ounce or 2 tablespoon/serving) per day for three days
Intervention Type
Dietary Supplement
Intervention Name(s)
tart cherry concentrate
Intervention Description
Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery
Primary Outcome Measure Information:
Title
Patient-reported tolerability score
Description
Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale
Time Frame
One week
Title
Efficacy as measured by total number of days in hospital within 60 days of surgery
Description
Total number of days in hospital within 60 days of the index surgery
Time Frame
60 days
Title
Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
Description
Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time to conversion to normal sinus rhythm
Description
Perioperative time to conversion to normal sinus rhythm
Time Frame
30 days
Title
Heart rhythm at hospital discharge
Description
Heart rhythm at hospital discharge
Time Frame
30 days
Title
Heart rhythm at 30 days
Description
Heart rhythm at 30 days
Time Frame
30 days
Title
Need for permanent pacemaker within 30 days of surgery
Description
Need for permanent pacemaker within 30 days of surgery
Time Frame
30 days
Title
Cerebrovascular thromboembolism [stroke, TIA]
Description
Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA]
Time Frame
30 days
Title
Non-cerebrovascular thromboembolism
Description
Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism
Time Frame
30 days
Title
Bleeding
Description
Incidences (yes/no, total number) of Bleeding
Time Frame
30 days
Title
Cerebrovascular events
Description
Incidences (yes/no, total number) of Cerebrovascular events
Time Frame
30 days
Title
Incidences of postoperative clinical events
Description
Incidences (yes/no, total number) of Non-cerebrovascular events
Time Frame
30 days
Title
Length of Hospital Stay
Description
LOS [Index hospitalization]
Time Frame
60 days
Title
Number of Re-hospitalization and ED visits
Description
Number of Re-hospitalization and ED visits
Time Frame
60 days
Title
Number of Outpatient Interventions
Description
Number of Outpatient interventions
Time Frame
60 days
Title
Total Costs for Hospital stay
Description
Costs [incident hospital stay]
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 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, no hx of AF)
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
Known sensitivity to sorbitol
Known gastric sensitivity to acidic juices like orange juice
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven F Bolling, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
China Green
Phone
734-936-7731
Email
chjgreen@med.umich.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence
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