NCT05469165RecruitingPhase 2
Serotonin Receptor Blockers in Ischemic Mitral Regurgitation
Blocking the Effects of Serotonin to Prevent Ischemic Mitral Regurgitation: a Randomized Trial (CYPRO-MR)
Source: ClinicalTrials.gov · Last updated 15 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is intended to investigate the effect of cyproheptadine (a 5HT2B receptor blocker) on mitral regurgitation severity.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 214 (estimated)
- First submitted
- 19 Jul 2022
- Start date
- 20 Jun 2023
- Primary completion date
- Sept 2026
- Lead sponsor
- Laval University
- Diseases
- Coronary artery disease
- NCT number
- NCT05469165
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 214
- From 20 Jun 2023 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior mitral valve procedure/surgery
- Ongoing treatment with selective serotonin reuptake inhibitor (SSRI)
- Chronic use of sedative medication
- Symptom or prior episode of urinary obstruction or glaucoma (relative contraindications for cyproheptadine)
Other illness
- Primary mitral disease (endocarditis, rheumatic, degenerative or congenital)
- More than mild valvular disease (other than mitral) at baseline
- Planned cardiac surgery (CABG or valve intervention) within 3 months
- Neurocognitive disorder
Lab values
- Chronic renal failure with Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min
Other
- Inability to provide informed consent
- Hemodynamic instability / cardiogenic shock / papillary muscle rupture
- Permanent atrial fibrillation (limiting imaging and MR quantification)
- Contraindications for MRI
- Ongoing or planned pregnancy
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.