Health TrialsbyHealthPanel

Serotonin Receptor Blockers in Ischemic Mitral Regurgitation

ConditionIschemic Mitral Regurgitation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLaval University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cyproheptadine 4 Mg Oral Tablet

    Drug

    Cyproheptadine treatment for 3 months

  • Placebo

    Other intervention

    Placebo administration for 3months

Treatment groups

214 Participants
are divided into 2 treatment groups
Group A: Cyproheptadine 4 Mg Oral TabletExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in mitral regurgitation severity

Incidence of more than mild MR (MRI regurgitant fraction ≥ 20%) at 3 months (measured by MRI)

Time frame
Baseline, 3 months

Secondary outcomes

1

Change in mitral leaflet size

Mitral leaflet size (3D echo) and its variation vs baseline (measured by echocardiography)

Time frame
Baseline, 3 months
2

Change in mitral regurgitation grade

Mitral regurgitation grade (measured by echocardiography). Mitral regurgitation is graded on a scale of I-IV (grade I (mild MR), grade II (moderate MR), grade III (moderate-to-severe MR) and grade IV (severe MR)). A higher mitral regurgitation grade is generally associated with a worse outcome for the patient.

Time frame
Baseline, 3 months
3

Change in left ventricle size

Left ventricle size (measured by MRI )

Time frame
Baseline, 3 months
4

Change in left ventricle function

Left ventricle function (measured by MRI )

Time frame
Baseline, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laval University

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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