Tart Cherry Concentrate for Post-Operative Atrial Fibrillation

Overseen By China Green, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Michigan

Must not be taking: Antiarrhythmics, Corticosteroids

Disqualifiers: Age ≥ 80, Previous cardiac surgery, Active smoker, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using antiarrhythmic agents or corticosteroids (medications that affect the immune system).

What data supports the effectiveness of the treatment Tart Cherry Concentrate for post-operative atrial fibrillation?

Tart cherry concentrate is known for its antioxidant and anti-inflammatory properties, which have been shown to benefit cardiovascular health and reduce inflammation. These properties may help in managing conditions like atrial fibrillation by potentially reducing inflammation and oxidative stress in the heart. ^{1 2 3 4 5}

How is Tart Cherry Concentrate different from other treatments for post-operative atrial fibrillation?

Tart Cherry Concentrate is unique because it is a natural treatment derived from cherries, which may offer antioxidant and anti-inflammatory benefits, unlike conventional medications that are often synthetic and focus on directly altering heart rhythm or blood clotting. ^{6 7 8 9 10}

Research Team

Steven F Bolling, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

I am between 50-79 years old and having elective surgery for mitral valve repair without Cox MAZE, but may have CABG/tricuspid repair.

Your heartbeat is regular, and you have not had atrial fibrillation before.

Exclusion Criteria

I am 80 years old or older.

You are allergic to sorbitol.

I have been diagnosed with chronic or occasional atrial fibrillation before surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tart Cherry Concentrate for three days

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Tart Cherry Concentrate

Trial Overview 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.

Participant Groups

Group I: Tart Cherry Concentrate Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Cherry Marketing Institute, Dewitt MI (USA)

Collaborator

Trials

1

Recruited

50+

Findings from Research

Tart cherry does not significantly affect blood pressure or heart rate, but it can reduce inflammation markers like serum C-reactive protein, with a moderate level of certainty based on 21 randomized controlled trials.

A dose-response analysis suggests that increasing the tart cherry dosage by 30 ml can lead to a reduction in C-reactive protein levels by approximately 0.19 mg/l, indicating that proper dosing is important for its anti-inflammatory effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-dependent effect of tart cherry on blood pressure and selected inflammation biomarkers: A GRADE-assessed systematic review and meta-analysis of randomized controlled trials. Norouzzadeh, M., Hasan Rashedi, M., Shahinfar, H., et al.[2023]

A meta-analysis of 10 randomized controlled trials involving 147 participants showed that tart cherry concentrate significantly improves endurance exercise performance when consumed 7 days to 1.5 hours before exercise, with a standardized mean difference of 0.36.

The benefits of tart cherry concentrate for endurance performance may be attributed to its low glycemic index, anti-inflammatory and antioxidant properties, and its ability to enhance blood flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Tart Cherry Concentrate on Endurance Exercise Performance: A Meta-analysis. Gao, R., Chilibeck, PD.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Processed tart cherry products--comparative phytochemical content, in vitro antioxidant capacity and in vitro anti-inflammatory activity. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Antioxidant polyphenols from tart cherries (Prunus cerasus). [2019]

3. England pubmed.ncbi.nlm.nih.gov

Dose-dependent effect of tart cherry on blood pressure and selected inflammation biomarkers: A GRADE-assessed systematic review and meta-analysis of randomized controlled trials. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cardioprotective mechanisms of Prunus cerasus (sour cherry) seed extract against ischemia-reperfusion-induced damage in isolated rat hearts. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Tart Cherry Concentrate on Endurance Exercise Performance: A Meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Post-authorization safety study of Clottafact® , a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of prothrombin complex concentrates for the treatment of coagulopathy after cardiac surgery. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Use of Factor XIII (FXIII) concentrate in patients with congenital FXIII deficiency undergoing surgical procedures. [2015]

9. Italy pubmed.ncbi.nlm.nih.gov

Fibrinogen concentrate as first-line therapy in aortic surgery reduces transfusion requirements in patients with platelet counts over or under 100×10(9)/L. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Fibrinogen supplementation after cardiac surgery: insights from the Zero-Plasma trial (ZEPLAST). [2022]