A Phase 2a, Open-label, Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-224 in Participants with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction (MERCUTIO)

Conditions

Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

Brief summary

Incidence, severity, and causality of AEs and SAEs, Incidence of symptomatic resting LVEF < 50% by TTE, Incidence of resting LVEF ≤ 30% by TTE, Incidence of MACE, including cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, Incidence of hospitalizations (due to cardiovascular and noncardiovascular events), Incidence of HF events (including hospitalizations and urgent emergency room/outpatient visits for HF), Incidence of atrial fibrillation/flutter (new from screening and recurrent), Incidence of appropriate implantable cardioverter defibrillator therapy and resuscitated cardiac arrest, Incidence of ventricular tachyarrhythmias (includes ventricular XML File Identifier: 4aHMkMObTnpietQCrlOf/erzF34= Page 20/33 tachycardia, ventricular fibrillation, and Torsades de Pointes), Results of vital signs, physical exams, 12-lead ECG assessments (including HR), and clinical laboratory tests

Detailed description

Effect on LVOT gradient, PK/PD relationship, PK concentrations

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence, severity, and causality of AEs and SAEs, Incidence of symptomatic resting LVEF < 50% by TTE, Incidence of resting LVEF ≤ 30% by TTE, Incidence of MACE, including cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, Incidence of hospitalizations (due to cardiovascular and noncardiovascular events), Incidence of HF events (including hospitalizations and urgent emergency room/outpatient visits for HF), Incidence of atrial fibrillation/flutter (new from screening and recurrent), Incidence of appropriate implantable cardioverter defibrillator therapy and resuscitated cardiac arrest, Incidence of ventricular tachyarrhythmias (includes ventricular XML File Identifier: 4aHMkMObTnpietQCrlOf/erzF34= Page 20/33 tachycardia, ventricular fibrillation, and Torsades de Pointes), Results of vital signs, physical exams, 12-lead ECG assessments (including HR), and clinical laboratory tests	—

Measure

Time frame

Incidence, severity, and causality of AEs and SAEs, Incidence of symptomatic resting LVEF < 50% by TTE, Incidence of resting LVEF ≤ 30% by TTE, Incidence of MACE, including cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, Incidence of hospitalizations (due to cardiovascular and noncardiovascular events), Incidence of HF events (including hospitalizations and urgent emergency room/outpatient visits for HF), Incidence of atrial fibrillation/flutter (new from screening and recurrent), Incidence of appropriate implantable cardioverter defibrillator therapy and resuscitated cardiac arrest, Incidence of ventricular tachyarrhythmias (includes ventricular XML File Identifier: 4aHMkMObTnpietQCrlOf/erzF34= Page 20/33 tachycardia, ventricular fibrillation, and Torsades de Pointes), Results of vital signs, physical exams, 12-lead ECG assessments (including HR), and clinical laboratory tests

—

Secondary

Measure	Time frame
Effect on LVOT gradient, PK/PD relationship, PK concentrations	—

Countries

Italy, Poland, Spain

Outcome results