Using cyproheptadine to treat ischemic mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.