Pilot-Tart Cherry, Mitral Transcriptome, and POAF Incidence

Post-operative Atrial Fibrillation (POAF) Clinical Trial

Official title:

Pilot-Tart Cherry, Mitral Transcriptome and POAF Incidence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03793465
• Other study ID #: HUM00145800
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 8, 2019
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: University of Michigan
• Contact: China Green, BS
• Phone: 734-936-7731
• Email: chjgreen[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Post-operative Atrial Fibrillation (POAF)

Intervention

Dietary Supplement:
• tart cherry concentrate
Consume 2 servings (1 ounce or 2 tablespoon/serving) per day for three days before cardiac surgery

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Cherry Marketing Institute, Dewitt MI (USA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported tolerability score	Patients will complete a brief questionnaire regarding gastrointestinal status, using the Bristol Stool Form Scale	One week
Primary	Efficacy as measured by total number of days in hospital within 60 days of surgery	Total number of days in hospital within 60 days of the index surgery	60 days
Primary	Efficacy as measured by altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NF?B activation	Altered (+/- 0.5 fold change) atrial transcript expression (mRNA) related to NF?B activation	30 days
Secondary	Time to conversion to normal sinus rhythm	Perioperative time to conversion to normal sinus rhythm	30 days
Secondary	Heart rhythm at hospital discharge	Heart rhythm at hospital discharge	30 days
Secondary	Heart rhythm at 30 days	Heart rhythm at 30 days	30 days
Secondary	Need for permanent pacemaker within 30 days of surgery	Need for permanent pacemaker within 30 days of surgery	30 days
Secondary	Cerebrovascular thromboembolism [stroke, TIA]	Incidences (yes/no, total number) of Cerebrovascular thromboembolism [stroke, TIA]	30 days
Secondary	Non-cerebrovascular thromboembolism	Incidences (yes/no, total number) of Non-cerebrovascular thromboembolism	30 days
Secondary	Bleeding	Incidences (yes/no, total number) of Bleeding	30 days
Secondary	Cerebrovascular events	Incidences (yes/no, total number) of Cerebrovascular events	30 days
Secondary	Incidences of postoperative clinical events	Incidences (yes/no, total number) of Non-cerebrovascular events	30 days
Secondary	Length of Hospital Stay	LOS [Index hospitalization]	60 days
Secondary	Number of Re-hospitalization and ED visits	Number of Re-hospitalization and ED visits	60 days
Secondary	Number of Outpatient Interventions	Number of Outpatient interventions	60 days
Secondary	Total Costs for Hospital stay	Costs [incident hospital stay]	60 days