NCT05469165

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for phase_2

Timeline
16mo left

Started Jun 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Jun 2023Sep 2027

First Submitted

Initial submission to the registry

July 19, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

3.2 years

First QC Date

July 19, 2022

Last Update Submit

November 13, 2023

Conditions

Ischemic Mitral Regurgitation

Keywords

Ischemic mitral regurgitationMyocardial infarctionMitral valveSerotoninCyproheptadine

Outcome Measures

Primary Outcomes (1)

  • Change in mitral regurgitation severity

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

    Baseline, 3 months

Secondary Outcomes (14)

  • Change in mitral leaflet size

    Baseline, 3 months

  • Change in mitral regurgitation grade

    Baseline, 3 months

  • Change in left ventricle size

    Baseline, 3 months

  • Change in left ventricle function

    Baseline, 3 months

  • Incidence of other valve regurgitation

    3 months

  • +9 more secondary outcomes

Study Arms (2)

Cyproheptadine 4 Mg Oral Tablet

EXPERIMENTAL

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.

Drug: Cyproheptadine 4 Mg Oral Tablet

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Cyproheptadine 4 Mg Oral TabletDRUG

Cyproheptadine treatment for 3 months

Also known as: Cyproheptadine
Cyproheptadine 4 Mg Oral Tablet
PlaceboOTHER

Placebo administration for 3months

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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% and wall motion in any territory.

You may not qualify 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Interventions

CyproheptadineTablets

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsDosage FormsPharmaceutical Preparations

Central Study Contacts

Jonathan Beaudoin, MD

CONTACT

(418) 656-8711jonathan.beaudoin@criucpq.ulaval.ca

Ons Marsit, PhD

CONTACT

(418) 656-8711ons.marsit.1@ulaval.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2022

First Posted

July 21, 2022

Study Start

June 20, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations

CA(1)