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5HT2B receptor blocker

Cyproheptadine for Mitral Valve Regurgitation (CYPRO-MR Trial)

Phase 2

Recruiting

Research Sponsored by Laval University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patients 18-80 years old with a 1st episode of STEMI with documented coronary obstruction

Must not have

Primary mitral disease (endocarditis, rheumatic, degenerative or congenital)

Chronic renal failure with Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 1 year

Summary

This trial looks at whether a drug can reduce severity of heart valve leaking, improving heart health.

Who is the study for?

This trial is for adults aged 18-80 who've had a first heart attack with blocked arteries and have specific types of heart muscle damage or weakness. It's not for those on sedatives, pregnant, with severe kidney issues, unable to consent, permanent irregular heartbeat, other major valve diseases, planned heart surgery soon, MRI contraindications, on antidepressants (SSRIs), cognitive disorders or at risk for urinary blockage/glaucoma.

What is being tested?

The study tests if cyproheptadine (a serotonin receptor blocker) can reduce the severity of leaky mitral valves in the heart after an ischemic event like a heart attack. Participants will either receive cyproheptadine tablets or placebo pills without active medication.

What are the potential side effects?

Cyproheptadine may cause drowsiness, dry mouth/nose/throat, blurred vision and constipation. In some cases it might lead to confusion or agitation especially in older adults. There's also a potential risk of urinary retention and glaucoma aggravation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's pumping ability is reduced and I have specific heart valve or wall motion issues.

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I am between 18 and 80 years old and have had my first heart attack with a blocked artery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart valve condition is due to infection, rheumatic disease, wear and tear, or was present at birth.

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My kidney function is severely reduced.

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I do not have heart instability or shock.

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I am currently taking SSRI medication.

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I have had surgery on my mitral valve before.

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I have ongoing atrial fibrillation that affects heart imaging tests.

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I have heart valve disease that is more severe than mild.

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I regularly use sedative medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mitral regurgitation severity

Secondary study objectives

Adverse events

Bleeding events

Change in depression score

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cyproheptadine 4 Mg Oral TabletExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 10Eligibility criteria met