University of Michigan
Ann Arbor, Michigan, 48109, United States
Active, Not Recruiting
NCT Number: NCT03793465
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.
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
50 year–79 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
tart cherry concentrate
Dietary SupplementConsume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery
Primary outcomes
-
Patient-reported tolerability score
Time frame: One week
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
Time frame: 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
Time frame: 30 days
Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
Secondary outcomes
-
Time to conversion to normal sinus rhythm
Time frame: 30 days
Perioperative time to conversion to normal sinus rhythm
-
Heart rhythm at hospital discharge
Time frame: 30 days
Heart rhythm at hospital discharge
-
Heart rhythm at 30 days
Time frame: 30 days
Heart rhythm at 30 days
-
Need for permanent pacemaker within 30 days of surgery
Time frame: 30 days
Need for permanent pacemaker within 30 days of surgery
-
Cerebrovascular thromboembolism [stroke, TIA]
Time frame: 30 days
Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA]
-
Non-cerebrovascular thromboembolism
Time frame: 30 days
Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism
-
Bleeding
Time frame: 30 days
Incidences (yes/no, total number) of Bleeding
-
Cerebrovascular events
Time frame: 30 days
Incidences (yes/no, total number) of Cerebrovascular events
-
Incidences of postoperative clinical events
Time frame: 30 days
Incidences (yes/no, total number) of Non-cerebrovascular events
-
Length of Hospital Stay
Time frame: 60 days
LOS [Index hospitalization]
-
Number of Re-hospitalization and ED visits
Time frame: 60 days
Number of Re-hospitalization and ED visits
-
Number of Outpatient Interventions
Time frame: 60 days
Number of Outpatient interventions
-
Total Costs for Hospital stay
Time frame: 60 days
Costs [incident hospital stay]
Sponsors and collaborators
Lead sponsor
University of Michigan
Other
Collaborators
- Cherry Marketing Institute
Registry information
Official study title
Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence
Important dates
- Study start
- 2019
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jan 4, 2019
- Registry last updated
- Feb 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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