Active — Not RecruitingPhase 1/2

Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

United States50 participantsStarted 2019-02-08

Plain-language 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.

Who can participate

Age range50 Years – 79 Years

SexALL

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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

What they're measuring

Patient-reported tolerability score

Timeframe: One week

Efficacy as measured by total number of days in hospital within 60 days of surgery

Timeframe: 60 days

Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NFκB activation

Timeframe: 30 days

Trial details

NCT IDNCT03793465

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Post-operative Atrial Fibrillation (POAF) trials