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A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

A Phase 2 Open-label Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

NCT02842242•MyoKardia, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this phase 2 open-label pilot study is to evaluate the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects with symptomatic HCM and LVOT obstruction aged 18-70 years.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosed with HCM (hypertrophied and non-dilated left ventricle in absence of systemic or other known cause), with LV wall thickness ≥ 15 mm at time of initial diagnosis or ≥ 13 mm with a positive family history of HCM.
•Age 18-70
•BMI 18-37kg/m2
•Documented LVEF ≥ 55% at the Screening visit as determined by the investigator and the investigational site's echocardiography laboratory.
•Resting LVOT gradient ≥ 30 mg Hg and post-exercise peak LVOT gradient ≥ 50 mm Hg
•NYHA functional class II or higher

Exclusion Criteria

•History of sustained ventricular tachyarrhythmia.
•History of syncope with exercise within past 6 months.
•Active infection.
•Persistent atrial fibrillation or atrial fibrillation at Screening or history of paroxysmal atrial fibrillation with resting rate document \> 100bpm within 1 year of screening.
•Has QTc Fridericia (QTcF) \> 500 ms, or any other ECG abnormality considered by the investigator to pose a risk to subject safety (e.g. second degree atrioventricular block type II).
•Aortic stenosis or fixed subaortic obstruction.
•History of LV systolic dysfunction (LVEF \< 45%) at any time during their clinical course.
•History of obstructive coronary artery disease.
•History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or MyoKardia physician, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
•Part A: Ongoing therapy with beta blockers, calcium channel blockers, or disopyramide. Subjects on any of these medications who, in the opinion of the investigator, can safely be withdrawn are eligible as long as medication is discontinued at least 14 days prior to the Screening visit.
+2 more criteria

Locations (7)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Tufts Medical Center

Boston, Massachusetts, United States

Washington University St. Louis

St Louis, Missouri, United States

Duke Health Center at Southpoint

Durham, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

Hospital of the University of Pennsylvania (Penn Heart and Vascular Center)

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

August 1, 2016

Primary Completion Date

November 1, 2017

Completion Date

November 1, 2017

Last Updated

June 8, 2021

Enrollment

ACTUAL participants

Conditions

Cardiomyopathy, Hypertrophic ObstructiveLeft Ventricular Outflow Tract Obstruction

Interventions

MYK-461

DRUG

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy

NCT04418297

Cardiomyopathy, Hypertrophic Obstructive

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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