Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

Phase 1

Active, not recruiting

• Conditions: Post-operative Atrial Fibrillation (POAF)
• Interventions: Dietary Supplement: tart cherry concentrate

• Registration Number: NCT03793465
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Study Start: 2019-02-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tart Cherry Concentrate	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

Primary Outcome Measures

Name	Time	Method
Efficacy as measured by total number of days in hospital within 60 days of surgery	60 days	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	30 days	Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
Patient-reported tolerability score	One week	Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States