Blocking the Effects of Serotonin to Prevent Ischemic Mitral Regurgitation: a Randomized Trial (CYPRO-MR)
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study is intended to investigate the effect of cyproheptadine (a 5HT2B receptor blocker) on mitral regurgitation severity.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Patients 18-80 years old with a 1st episode of STEMI with documented coronary obstruction.
• 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.
Locations
Other Locations
Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
RECRUITING
Québec
Contact Information
Primary
Jonathan Beaudoin, MD
jonathan.beaudoin@criucpq.ulaval.ca
(418) 656-8711
Backup
Ons Marsit, PhD
ons.marsit.1@ulaval.ca
(418) 656-8711
Time Frame
Start Date: 2023-06-20
Estimated Completion Date: 2027-09
Participants
Target number of participants: 214
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: Laval University