Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

NCT03793465 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: HUM00145800
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Atrial Fibrillation (POAF)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Time to conversion to normal sinus rhythm

  30 days

• Heart rhythm at hospital discharge

  30 days

• Heart rhythm at 30 days

  30 days

• Need for permanent pacemaker within 30 days of surgery

  30 days

• Cerebrovascular thromboembolism [stroke, TIA]

  30 days

Study Arms (1)

Tart Cherry Concentrate

EXPERIMENTAL

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

Interventions

tart cherry concentrate DIETARY_SUPPLEMENT

Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery

Tart Cherry Concentrate

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Cherry Marketing Institute, Dewitt MI (USA): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Steven F Bolling, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: 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

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: February 8, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)