← Back to Search

Dietary Supplement

Tart Cherry Concentrate for Post-Operative Atrial Fibrillation

Phase 1 & 2

Recruiting

Led By Steven F Bolling, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

Study Summary

This trial will test whether tart cherry concentrate can reduce the incidence of post-operative atrial fibrillation (POAF) and improve other outcomes in cardiac surgery patients. Gene transcripts related to inflammation will be measured in cardiac tissue.

Who is the study for?

This trial is for men and women aged 50-79 who are undergoing elective mitral valve repair surgery but not the Cox MAZE procedure. Candidates should be in normal heart rhythm with no history of atrial fibrillation, no prior heart surgeries, pacemakers, or active smoking. They shouldn't have inflammatory diseases, autoimmune conditions, or be on immunosuppressive drugs.Check my eligibility

What is being tested?

The study tests if Tart Cherry Concentrate can reduce the incidence of post-operative atrial fibrillation (POAF) after cardiac surgery. It also looks at how this concentrate affects inflammation-related genes in heart tissue and its impact on clinical and economic outcomes.See study design

What are the potential side effects?

Potential side effects may include gastric sensitivity similar to reactions from acidic juices like orange juice due to tart cherry concentrate's acidity. There might also be a risk for those with known sorbitol sensitivity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Patient-reported tolerability score

Secondary outcome measures

Bleeding

Cerebrovascular events

Cerebrovascular thromboembolism [stroke, TIA]

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tart Cherry ConcentrateExperimental Treatment1 Intervention

Single arm, open-label design. Commercial Montmorency tart cherry juice concentrate. Servings (1 ounce or 2 tablespoon/serving) per day for three days

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,378,008 Total Patients Enrolled

11 Trials studying Atrial Fibrillation

7,232 Patients Enrolled for Atrial Fibrillation

Cherry Marketing Institute, Dewitt MI (USA)UNKNOWN

Steven F Bolling, MDPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Tart Cherry Concentrate (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03793465 — Phase 1 & 2

Atrial Fibrillation Research Study Groups: Tart Cherry Concentrate

Atrial Fibrillation Clinical Trial 2023: Tart Cherry Concentrate Highlights & Side Effects. Trial Name: NCT03793465 — Phase 1 & 2

Tart Cherry Concentrate (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03793465 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being welcomed into this research project at this time?

"Yes, as the latest update on clinicaltrials.gov shows, this study is still recruiting patients. The original posting was on February 8th, 2019 with the most recent update being March 11th, 2022."

Answered by AI

For which type of patient is this research project recruiting?

"This study is recruiting 50 patients that have atrial fibrillation and are aged between 50-79. Male and female patients that meet the following additional criteria may apply: scheduled for elective cardiac surgery at the Mitral Valve Clinic/CVC (that does not involve the Cox MAZE procedure), in sinus rhythm (no history of pre-operative atrial fibrillation or AF)."

Answered by AI

What benefits does this clinical trial hope to bring patients?

"The primary outcome of this medical study, which will be evaluated over 60 days, is efficacy as measured by altered atrial transcript expression (mRNA) related to NFκB activation. Secondary outcomes that will also be assessed include heart rhythm at hospital discharge, the need for a permanent pacemaker within 30 days of surgery, and cerebrovascular thromboembolism [stroke, TIA]."

Answered by AI

Can people over the age of 35 enroll in this research project?

"The age limit for enrolment in this trial is 50 to 79 years old."

Answered by AI

How many volunteers are helping to test this new medication?

"Yes, as indicated by the listing on clinicaltrials.gov, this research is actively recruiting patients. The study was first posted on February 8th, 2019 and updated March 11th, 2022. Currently, 50 people are needed to participate at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

Steven Bolling 2019. "Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03793465.