Hypertrophic Cardiomyopathy (HCM)
Conditions
Keywords
mavacamten, oHCM, cardiac myosin inhibitor, NYHA class, echocardiogram parameters, patient-reported outcomes
Brief summary
COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice.
Detailed description
The mavaCamten ObservationaL evIdence Global cOnsortium in hypertrophic cardiomyopathy (COLLIGO-HCM) is a global observational research initiative aiming to describe the real-world outcomes of treatments for obstructive hypertrophic cardiomyopathy (HCM), including mavacamten. This retrospective study uses data from existing medical records and electronic registries from HCM centers around the world.
Interventions
DRUGApproved Hypertrophic Cardiomyopathy drug treatments
As per product label
DRUGMavacamten
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Source Cohort \- Have at least one recorded encounter with a Hypertrophic Cardiomyopathy (HCM) diagnosis during or after 2018 (the first is defined as the index) and aged ≥18 years on the index date. \- Disease-specific patient history documented in the medical record. * HCM Sub-Cohort \- Participants in the source cohort with a known HCM diagnosis * Mavacamten Sub-Cohort - Participants who have their first mavacamten prescription after the index date
Exclusion criteria
• HCM Sub-Cohort \- HCM phenocopy (athlete's heart, hypertensive heart disease, Fabry disease, Pompe disease, Danon disease, amyloidosis) observed after the first observed HCM-associated encounter in the medical record.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms | Baseline and index date | — |
| Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM) | Baseline, index date, and up to 33 months | — |
| Participant family history of sudden cardiac death (SCD) | Baseline, index date, and up to 33 months | — |
| Cardiovascular (CV) and CV-related comorbidities | Baseline | Including: * Aortic stenosis * Cardiomyopathies * Chronic kidney disease * Coronary heart disease * Heart failure * Hyperlipidemia * Hypertension (primary) * 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) |
| Non-cardiovascular (non-CV) comorbidities | Baseline | Including: * Anxiety/panic attacks * Asthma * COPD * Depression * Diabetes * Liver disease |
| Participant electrocardiogram (ECG) rhythm results | Baseline | — |
| Participant echocardiogram (ECHO) results | Baseline and index date | — |
| Participant cardiac MRI results | Baseline | — |
| Participant NT-proBNP results | Baseline | — |
| Participant cardiac tropin results | Baseline | — |
| Participant cardiopulmonary exercise test (CPET) results | Baseline | — |
| Participant cardiac monitoring results | Baseline | — |
| Participant exercise test results | Baseline | — |
| Hypertrophic Cardiomyopathy (HCM) subtype | Baseline, index date, and up to 33 months | — |
| Participant symptoms at Hypertrophic Cardiomyopathy (HCM) | Baseline, index date, and up to 33 months | — |
| Participant New York Heart Association (NYHA) class | Baseline, 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 | — |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed