← Back to Search

5HT2B receptor blocker

Cyproheptadine for Mitral Valve Regurgitation (CYPRO-MR Trial)

Q: Is the target demographic of this trial restricted to those aged 60 or below?

This study is searching for volunteers aged 18 and above, but under the age of 80.

Q: What is the maximum cohort size for this clinical trial?

Accurately, according to the information found on clinicaltrials.gov this experiment is currently recruiting participants. It was first posted on June 20th 2023 and was most recently updated on November 13th 2023. To be successful it requires 214 volunteers from one location.

Q: What type of candidates is this trial recruiting?

In order to qualify for this clinical trial, applicants must have mitral regurgitation and be within the age range of 18-80. This research study is hoping to enroll a total of 214 individuals.

Q: Is enrolment still available for this experiment?

The clinical trial, whose initial posting was on June 20th 2023, is actively recruiting patients according to the information provided on clinicaltrials.gov. This data was most recently updated on November 13th 2023.

Q: Is Cyproheptadine 4 Mg Oral Tablet an innocuous remedy for patients?

Our team has assessed the safety of Cyproheptadine 4 Mg Oral Tablet with a score of 2. This grade is reflective of this being a Phase 2 experiment, indicating some evidence exists to support its security but not necessarily its efficacy.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 1 year

Awards & highlights

CYPRO-MR Trial 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.Check my eligibility

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.See study design

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.

CYPRO-MR Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

CYPRO-MR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in mitral regurgitation severity

Secondary outcome measures

Adverse events

Bleeding events

Change in depression score

+11 more

Side effects data

From 2010 Phase 2 trial • 14 Patients • NCT01076283

29%

sedation

14%

yellow urine

14%

constipation

14%

dental pain

14%

sleepness

100%

80%

60%

40%

20%

Study treatment Arm

Cyproheptadine

Baclofen

CYPRO-MR 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,300 Total Patients Enrolled

Laval UniversityLead Sponsor

417 Previous Clinical Trials

172,058 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the target demographic of this trial restricted to those aged 60 or below?

"This study is searching for volunteers aged 18 and above, but under the age of 80."

Answered by AI

What is the maximum cohort size for this clinical trial?

"Accurately, according to the information found on clinicaltrials.gov this experiment is currently recruiting participants. It was first posted on June 20th 2023 and was most recently updated on November 13th 2023. To be successful it requires 214 volunteers from one location."

Answered by AI

What type of candidates is this trial recruiting?

"In order to qualify for this clinical trial, applicants must have mitral regurgitation and be within the age range of 18-80. This research study is hoping to enroll a total of 214 individuals."

Answered by AI

Is enrolment still available for this experiment?

"The clinical trial, whose initial posting was on June 20th 2023, is actively recruiting patients according to the information provided on clinicaltrials.gov. This data was most recently updated on November 13th 2023."

Answered by AI

Is Cyproheptadine 4 Mg Oral Tablet an innocuous remedy for patients?

"Our team has assessed the safety of Cyproheptadine 4 Mg Oral Tablet with a score of 2. This grade is reflective of this being a Phase 2 experiment, indicating some evidence exists to support its security but not necessarily its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Serotonin Receptor Blockers in Ischemic Mitral Regurgitation

2023. "Serotonin Receptor Blockers in Ischemic Mitral Regurgitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05469165.

All > Anterior Ischemic Optic Neuropathy