Using cyproheptadine to treat ischemic mitral regurgitation
Blocking the Effects of Serotonin to Prevent Ischemic Mitral Regurgitation: a Randomized Trial (CYPRO-MR)
This study is testing if cyproheptadine can help people with ischemic mitral regurgitation after a heart attack by looking at changes in their heart and valve function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec) |
| Trial ID | NCT05469165 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of cyproheptadine, a 5HT2B receptor blocker, on the severity of ischemic mitral regurgitation (MR) following a first episode of ST-elevation myocardial infarction (STEMI). The trial is designed as a double-blind randomized controlled trial, where participants will receive either cyproheptadine or a placebo. The study aims to assess changes in mitral valve surface area, left ventricular size, and MR severity through serial imaging techniques such as 3D echocardiography and MRI. The underlying hypothesis is that cyproheptadine may prevent adverse remodeling of the mitral valve due to fibrotic changes associated with elevated serotonin levels after myocardial infarction.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 who have experienced a first episode of STEMI with specific left ventricular dysfunction criteria.
Not a fit: Patients with prior mitral valve surgery, severe hemodynamic instability, or other significant valvular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the severity of ischemic mitral regurgitation and improve heart function in affected patients.
How similar studies have performed: While the approach of using serotonin receptor blockers is novel in this context, previous studies in animal models have shown promising results in preventing valve remodeling.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Québec
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec, Canada (Recruiting)
Study contacts
- Study coordinator: Jonathan Beaudoin, MD
- Email: jonathan.beaudoin@criucpq.ulaval.ca
- Phone: (418) 656-8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.