COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Condition(s) studied

Investigational drug(s) / intervention(s)

Approved Hypertrophic Cardiomyopathy drug treatments: As per product label

Mavacamten: As per product label

Study summary

COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice.

Eligibility

Primary outcome measure(s)

• Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis — Baseline, index date
• Participant age at mavacamten treatment initiation — Index date
• Participant sex — Baseline
• Participant race/ethnicity — Baseline
• Participant insurance coverage — Baseline
• Participant employment status — Baseline
• Participant educational level — Baseline
• Date of Hypertrophic Cardiomyopathy (HCM) diagnosis — Baseline or index date
• Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis — Baseline or index date
• Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis — Baseline or index date
• Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis — Baseline or index date, and up to 33 months
• Participant New York Heart Association (NYHA) class — Baseline or index date, and up to 33 months
• Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis — Baseline
• Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis — Baseline
• Participant height — Baseline
• Participant weight — Baseline
• Participant blood pressure — Baseline
• Participant heart rate — Baseline
• Participant Hypertrophic Cardiomyopathy (HCM) symptoms — Baseline or index date, and up to 33 months
• European participant CYP2C19 genotype — Baseline or index date, and up to 33 months
• Participant family history of Hypertrophic Cardiomyopathy (HCM) — Baseline or index date
• Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM) — Baseline or index date
• Participant family history of sudden cardiac death (SCD) — Baseline or index date
• Participant smoking status — Baseline or index date
• Participant alcohol use — Baseline or index date
• Participant recreational drug use — Baseline or index date
• Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT) — Baseline or index date, and up to 33 months
• Participant cardiovascular (CV) and CV-related comorbidities — Baseline and index date
  Comorbidities include: * Aortic stenosis * Cardiomyopathies, other (dilated, restrictive, arrhythmogenic right ventricular dysplasia, takotsubo cardiomyopathy) * Chronic kidney disease * Coronary heart disease * Deep venous thrombosis (DVT) * Heart failure * Hyperlipidemia * Hypertension * Hypertensive renal disease * Mitral valve prolapse * Peripheral vascular disease * Pulmonary hypertension * Phenocopy disorders (athlete's heart, hypertensive heart disease, Fabry disease, Pompe disease, Danon disease, amyloidosis)
• Participant non-cardiovascular (CV)-related comorbidities — Baseline or index date
  Including: * Anxiety/panic attacks * Asthma * COPD * Depression * Diabetes * Liver diseases
• Participant electrocardiogram (ECG) rhythm results — Baseline or index date
• Participant cardiac magnetic resonance imaging (MRI) results — Baseline or index date
• Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results — Baseline or index date
• Participant cardiac troponin results — Baseline or index date
• Participant cardiopulmonary exercise test (CPET) results — Baseline or index date
• Participant cardiac monitoring results — Baseline or index date
• Participant exercise test results — Baseline or index date
• Participant blood creatine levels — Baseline or index date
• Participant cardiovascular (CV) events — Baseline
  Cardiovascular events include: * Atrial fibrillation * Atrial flutter * Myocardial infarction (MI) * Stroke * Transient ischemic attack (TIA) * Cardiac arrest * Sudden cardiac death (SCD) * Arrhythmia * Heart failure exacerbation * Incident heart failure * Ventricular fibrillation * Syncope
• Type of procedures received by participants — Baseline or index date, and up to 33 months
  Procedures include: * Septal reduction therapy (SRT) * Implantable cardioverter defibrillator (ICD), including CRT-D * Pacemaker * Cardiac resynchronization therapy (CRT) * Atrial fibrillation ablation * Cardioversion * Heart transplant/use of ventricular assist device * Heart failure monitoring (e.g., CardioMEMS) * Percutaneous cutaneous intervention (PCI)
• Cardiovascular treatments prescribed to participants — Baseline, and up to 33 months
• Date of mavacamten prescription — Baseline
• Date of mavacamten treatment initiation — Index date
• Date of mavacamten dosage change — Up to 33 months
• Reason for mavacamten dosage change — Up to 33 months
• Occurrence of mavacamten stable dose (a period of 6-months with the same dose) — Up to 33 months
• Dates of follow-up after mavacamten treatment initiation — Up to 33 months
• Date of mavacamten treatment interuption or discontinuation — Up to 33 months
• Reason for mavacamten treatment interuption or discontinuation — Up to 33 months
• Supportive care provided to participants — Up to 33 months
• Heath care resource utilization (HCRU) — Up to 33 months
• Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation — Up to 33 months

Trial sites (1)

More Bristol-Myers Squibb trials in the USA