Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post-operative Atrial Fibrillation (POAF)
• Intervention / Treatment: Dietary supplement: tart cherry concentrate

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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)
2. In sinus rhythm (no pre-operative atrial fibrillation, no hx of AF)

Exclusion Criteria:

1. Age ≥ 80 years
2. Diagnosed pre-operative chronic or paroxysmal AF
3. Prior ablation procedure for AF
4. Previous cardiac surgery
5. Implanted pacemaker
6. Active smoker
7. Comorbidities such as congenital or cardiac re-operation
8. Use of antiarrhythmic agents
9. Active inflammatory or infectious disease or malignancy
10. Diagnosed autoimmune disease
11. Corticosteroid or other immunomodulatory or immunosuppressive medication
12. Known sensitivity to sorbitol
13. Known gastric sensitivity to acidic juices like orange juice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tart Cherry Concentrate; Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Servings (1 ounce or 2 tablespoon/serving) per day for three days	Dietary supplement: tart cherry concentrate; Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported tolerability score	Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale	One week
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	60 days
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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to conversion to normal sinus rhythm	Perioperative time to conversion to normal sinus rhythm	30 days
Heart rhythm at hospital discharge	Heart rhythm at hospital discharge	30 days
Heart rhythm at 30 days	Heart rhythm at 30 days	30 days
Need for permanent pacemaker within 30 days of surgery	Need for permanent pacemaker within 30 days of surgery	30 days
Cerebrovascular thromboembolism [stroke, TIA]	Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA]	30 days
Non-cerebrovascular thromboembolism	Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism	30 days
Bleeding	Incidences (yes/no, total number) of Bleeding	30 days
Cerebrovascular events	Incidences (yes/no, total number) of Cerebrovascular events	30 days
Incidences of postoperative clinical events	Incidences (yes/no, total number) of Non-cerebrovascular events	30 days
Length of Hospital Stay	LOS [Index hospitalization]	60 days
Number of Re-hospitalization and ED visits	Number of Re-hospitalization and ED visits	60 days
Number of Outpatient Interventions	Number of Outpatient interventions	60 days
Total Costs for Hospital stay	Costs [incident hospital stay]	60 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Cherry Marketing Institute, Dewitt MI (USA)
• Investigators: Principal Investigator: Steven F Bolling, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: HUM00145800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No