Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-08

Study Completion Date

2027-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-operative Atrial Fibrillation (POAF)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

tart cherry concentrate

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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tart cherry concentrate

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No