Clinical trial NCT03793465: Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence
Official title: Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Post-operative Atrial Fibrillation (POAF)
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Cherry Marketing Institute, Dewitt MI (USA)
First posted: 2019-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported tolerability score
timeFrame: One week
measure: Efficacy as measured by total number of days in hospital within 60 days of surgery
timeFrame: 60 days
measure: Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation
timeFrame: 30 days
Secondary outcomes:
measure: Time to conversion to normal sinus rhythm
timeFrame: 30 days
measure: Heart rhythm at hospital discharge
timeFrame: 30 days
measure: Heart rhythm at 30 days
timeFrame: 30 days
measure: Need for permanent pacemaker within 30 days of surgery
timeFrame: 30 days
measure: Cerebrovascular thromboembolism [stroke, TIA]
timeFrame: 30 days
measure: Non-cerebrovascular thromboembolism
timeFrame: 30 days
measure: Bleeding
timeFrame: 30 days
measure: Cerebrovascular events
timeFrame: 30 days
measure: Incidences of postoperative clinical events
timeFrame: 30 days
measure: Length of Hospital Stay
timeFrame: 60 days
measure: Number of Re-hospitalization and ED visits
timeFrame: 60 days
measure: Number of Outpatient Interventions
timeFrame: 60 days
measure: Total Costs for Hospital stay
timeFrame: 60 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Steven F Bolling, MD
role: PRINCIPAL_INVESTIGATOR
References: