Hypertrophic Cardiomyopathy Clinical Trial

A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Summary

The purpose of this study is to characterize the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MYK-224 in participants with obstructive Hypertrophic Cardiomyopathy (oHCM)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has adequate acoustic windows, to enable accurate TTEs as determined by the echocardiography core laboratory.

Men or women diagnosed with oHCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines, satisfying both of the following criteria:

Has unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 millimeter (mm) (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy or with a known disease-causing mutation), as determined by core laboratory interpretation.

AND

-- Has a LVOT peak gradient during screening as assessed by echocardiography of ≥ 50 millimeters of mercury (mm Hg) at rest, or ≥ 30 mm Hg at rest and ≥ 50 mm Hg after Valsalva maneuver (confirmed by echocardiography core laboratory interpretation).

Has documented LVEF ≥ 60% at the Screening visit as determined by echocardiography core laboratory.
New York Heart Association (NYHA) functional class II or III symptoms at screening.
Has a valid measurement of LVOT post-exercise peak gradient at screening as determined by echocardiography core laboratory.

Exclusion Criteria:

Presence of any medical condition that precludes exercise stress testing.
History of syncope or sustained ventricular tachyarrhythmia within 6 months prior to screening.
Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with left ventricular hypertrophy.
Prior treatment with mavacamten or aficamten. An exception may be made in cases where myosin inhibitor use was not within 4 months of the Screening visit, and with the agreement of both the Investigator and the Sponsor Medical Monitor.
Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) within 6 months prior to Screening or plans to have either of these treatments during the study (Note: Individuals with an unsuccessful myectomy or percutaneous ASA procedure performed > 6 months prior to Screening may be enrolled if study eligibility criteria for LVOT gradient criteria are met).
Implantable cardioverter-defibrillator (ICD) placement or pulse generator change within 2 months prior to screening or planned new ICD placement during the study (pulse generator changes, if needed during the study are allowed).
Has a history of resuscitated sudden cardiac arrest (any time) or known history of appropriate implantable cardioverter-defibrillator (ICD discharge for life-threatening ventricular arrhythmia within 6 months prior to screening.
Has paroxysmal, intermittent atrial fibrillation with atrial fibrillation present per the Investigator's evaluation of the participant's ECG at the time of Screening.
Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening (Note: Participants with persistent or permanent atrial fibrillation who are anticoagulated and adequately rate-controlled are allowed).
Has QT interval with Fridericia correction (QTcF) > 500 msec when QRS interval < 120 msec or QTcF > 520 msec when QRS ≥ 120 msec if participant has left bundle branch block or any other 12-lead ECG abnormality considered by the investigator to pose a risk to participant safety (eg, second-degree atrioventricular block type II).
Has known moderate or severe (per investigator's judgment) aortic valve stenosis at screening.
History of LV systolic dysfunction (LVEF < 45%) at any time during their clinical course.
Has pulmonary disease that limits exercise capacity.
History of obstructive coronary artery disease (stenosis of > 70% of luminal diameter in one or more coronary arteries).
Prior treatment with cardiotoxic agents such as anthracyclines (eg, doxorubicin) or similar

Other protocol-defined criteria apply.

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

36

Study ID:

NCT05556343

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 19 Locations for this study

See Locations Near You

University of California San Diego - Sulpizio Cardiovascular Center
La Jolla California, 92037, United States More Info
Jorge Silva Enciso, Site 0026
Contact
858-246-2969
UCSF Medical Center - Adult Congenital Heart Disease Clinic
San Francisco California, 94158, United States More Info
Theodore Abraham, Site 0016
Contact
University of Kansas Medical Center (KUMC)
Kansas City Kansas, 66103, United States More Info
Loren Berenbom, Site 0001
Contact
+910771569
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York New York, 10029, United States More Info
Bette Kim, Site 0033
Contact
212-492-5550
Columbia Weill Cornell Cancer Centers - Herbert Irving Comprehensive Cancer Center (HICCC)
New York New York, 10032, United States More Info
Yuichi Shimada, Site 0032
Contact
Oregon Health & Science University (OHSU) - Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Ahmad Masri, Site 0024
Contact
503-494-7551
University of Utah, University Hospital
Salt Lake City Utah, 84132, United States More Info
Omar Wever-Pinzon, Site 0006
Contact
801-581-7735
Local Institution - 0027
Bologna BO, 40138, Italy More Info
Site 0027
Contact
Local Institution - 0005
Firenze FI, 50134, Italy More Info
Site 0005
Contact
Local Institution - 0011
Katowice SL, 40-55, Poland More Info
Site 0011
Contact
Local Institution - 0004
Warszawa , 04-62, Poland
Local Institution - 0022
Granada GR, 18014, Spain More Info
Site 0022
Contact
Local Institution - 0010
Majadahonda Madrid, 28222, Spain More Info
Site 0010
Contact
Local Institution - 0008
Málaga MA, 29010, Spain More Info
Site 0008
Contact
Local Institution - 0002
El Palmar MU, 30120, Spain More Info
Site 0002
Contact
Local Institution - 0003
Valencia V, 46026, Spain More Info
Site 0003
Contact
Local Institution - 0009
A Coruña , 15006, Spain More Info
Site 0009
Contact
Local Institution - 0028
Alicante/alacant , 03010, Spain More Info
Site 0028
Contact
Local Institution - 0023
Barcelona , 08036, Spain More Info
Site 0023
Contact

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

36

Study ID:

NCT05556343

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.