Cardiomyopathy, Hypertrophic
Conditions
Keywords
BMS-986427, MYK-461, Mavacamten, Obstructive Hypertrophic Cardiomyopathy (oHCM), Camyzos, Cardiac Magnetic Resonance Imaging (CMR)
Brief summary
The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) \[New York Heart Association (NYHA) Functional Class II or III\].
Interventions
DRUGMavacamten
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:. * Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mmHg and ≥ 50 mmHg after Valsalva or after exercise. * Left ventricular ejection fraction (LVEF) ≥ 55% at rest. * New York Heart Association (NYHA) functional class II or III symptoms.
Exclusion criteria
* A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM. * Documented obstructive coronary artery disease or history of myocardial infarction. * A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening. * An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR). * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48 | At week 48 | Participants achieving both of the following criteria at Week 48 cardiac magnetic resonance imaging (CMR) assessment: * A decrease of at least 5 mL/m2 in maximum LAVI from baseline * A decrease of at least 5 g/m2 in LVMI from baseline |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48 | At week 48 |
| Change from baseline in maximum left atrial volume index (LAVI) at Week 48 | At week 48 |
| Change from baseline in left ventricular mass index (LVMI) at Week 48 | At week 48 |
| Incidence of major adverse cardiac events (MACE) | Up to 48 weeks |
| Incidence of MACE-expanded events | Up to 48 weeks |
| All-cause mortality | Up to 48 weeks |
| Incidence of heart failure (HF) events | Up to 48 weeks |
| Incidence of HF events with systolic dysfunction | Up to 48 weeks |
| Incidence of atrial fibrillation (AF)/atrial flutter | Up to 48 weeks |
| Incidence of cardiovascular (CV) mortality | Up to 48 weeks |
| Incidence of ventricular tachyarrhythmias | Up to 48 weeks |
| Incidence of nonvasovagal syncope and seizures | Up to 48 weeks |
| Incidence of treatment emergent adverse events (TEAEs) | Up to 48 weeks |
| Severity of TEAEs | Up to 48 weeks |
| Incidence of treatment emergent serious adverse events (SAEs) | Up to 48 weeks |
| TEAEs leading to discontinuation from study intervention | Up to 48 weeks |
| TEAEs leading to laboratory abnormalities | Up to 48 weeks |
Countries
Argentina, Australia, Canada, Switzerland, United Kingdom, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed