Recruiting
Phase 2

Serotonin Receptor Blockers

Sponsor:

Laval University

Code:

NCT05469165

Conditions

Ischemic Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cyproheptadine 4 Mg Oral Tablet

Placebo

Study Details

Brief summary:

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

Conditions

Ischemic Mitral Regurgitation

Study ID

NCT05469165

Start date

Jun 20, 2023

Status verified date

Nov, 2023

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

214 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cyproheptadine 4 Mg Oral Tablet

Participants will receive cyproheptadine 4mg tablet orally three times a day for three months, with a daily increase of 4mg/dose if the previous dose was well tolerated, up to 0.5 mg/kg/day.

placebo comparator: Placebo

Participants will receive a matched placebo orally three times a day for 3 months. Daily titration similar to the treatment arm.

Interventions

Cyproheptadine 4 Mg Oral Tablet

Cyproheptadine treatment for 3 months

Placebo

Placebo administration for 3months

Primary outcome measure

  • Change in mitral regurgitation severity [ Time Frame: Baseline, 3 months ]

Central Contacts and Locations

Central contacts

Jonathan Beaudoin, MD

(418) 656-8711jonathan.beaudoin@criucpq.ulaval.ca

Ons Marsit, PhD

(418) 656-8711ons.marsit.1@ulaval.ca

Locations

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Recruiting

Québec, Canada, G1V 4G5

Contacts

Jonathan Beaudoin, MD

418 656-8711

More Information

Sponsor

Laval University

Last update posted

Nov 15, 2023

Last verified

Nov, 2023

Keywords

  • Ischemic mitral regurgitation
  • Myocardial infarction
  • Mitral valve
  • Serotonin
  • Cyproheptadine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2023-11-15.