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New treatment option for Ischemic Mitral Regurgitation
Official title Serotonin Receptor Blockers in Ischemic Mitral Regurgitation
ClinicalTrials.gov ID: NCT05469165
What this study is testing
What is Cyproheptadine 4 Mg Oral Tablet?
Cyproheptadine 4 Mg Oral Tablet is an investigational medicine, being studied as a potential treatment for ischemic mitral regurgitation.
Also referred to as Cyproheptadine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is intended to investigate the effect of cyproheptadine (a 5HT2B receptor blocker) on mitral regurgitation severity.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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%...
You likely can't join if
- Inability to provide informed consent
- Hemodynamic instability / cardiogenic shock / papillary muscle rupture
- Prior mitral valve procedure/surgery
- Permanent atrial fibrillation (limiting imaging and MR quantification)
- Primary mitral disease (endocarditis, rheumatic, degenerative or congenital)
- More than mild valvular disease (other than mitral) at baseline
See the full eligibility criteria
- 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.
- Inability to provide informed consent
- Hemodynamic instability / cardiogenic shock / papillary muscle rupture
- Prior mitral valve procedure/surgery
- Permanent atrial fibrillation (limiting imaging and MR quantification)
- 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
- Contraindications for MRI
- Ongoing treatment with selective serotonin reuptake inhibitor (SSRI)
- Chronic use of sedative medication
- Ongoing or planned pregnancy
- Chronic renal failure with Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min
- Neurocognitive disorder
- Symptom or prior episode of urinary obstruction or glaucoma (relative contraindications for cyproheptadine)
The study team makes the final eligibility decision.
Where it's taking place
- Québec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Québec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.