Blocking the Effects of Serotonin to Prevent Ischemic Mitral Regurgitation: a Randomized Trial

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to investigate the effect of cyproheptadine (a 5HT2B receptor blocker) on mitral regurgitation severity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laval University
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Cyproheptadine

Criteria

Inclusion Criteria:

1. Patients 18-80 years old with a 1st episode of STEMI with documented coronary obstruction.

2. Left ventricle ejection fraction (LVEF)<50% and mitral tenting area ≥ 4 cm2, OR LVEF ≤ 40% and inferior/posterior wall motion anomaly, OR LVEF≤30% and wall motion in any territory.

Exclusion Criteria:

1. Inability to provide informed consent

2. Hemodynamic instability / cardiogenic shock / papillary muscle rupture

3. Prior mitral valve procedure/surgery

4. Permanent atrial fibrillation (limiting imaging and MR quantification)

5. Primary mitral disease (endocarditis, rheumatic, degenerative or congenital)

6. More than mild valvular disease (other than mitral) at baseline

7. Planned cardiac surgery (CABG or valve intervention) within 3 months

8. Contraindications for MRI

9. Ongoing treatment with selective serotonin reuptake inhibitor (SSRI)

10. Chronic use of sedative medication

11. Ongoing or planned pregnancy

12. Chronic renal failure with Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min

13. Neurocognitive disorder

14. Symptom or prior episode of urinary obstruction or glaucoma (relative contraindications for cyproheptadine)