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

N/AActive Not RecruitingNCT06372457

Bristol-Myers Squibb500 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Hypertrophic Cardiomyopathy (HCM)

Interventions

Approved Hypertrophic Cardiomyopathy drug treatmentsDRUG

As per product label

MavacamtenDRUG

As per product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

IQVIA

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis

Time frame: Baseline, index date

Participant age at mavacamten treatment initiation

Time frame: Index date

Participant sex

Time frame: Baseline

Participant race/ethnicity

Time frame: Baseline

Participant insurance coverage

Time frame: Baseline

Participant employment status

Time frame: Baseline

Participant educational level

Time frame: Baseline

Date of Hypertrophic Cardiomyopathy (HCM) diagnosis

Time frame: Baseline or index date

Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis

Time frame: Baseline or index date

Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis

Time frame: Baseline or index date

Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis

Time frame: Baseline or index date, and up to 33 months

Participant New York Heart Association (NYHA) class

Time frame: Baseline or index date, and up to 33 months

Data from ClinicalTrials.gov

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Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis

Time frame: Baseline

Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis

Time frame: Baseline

Participant height

Time frame: Baseline

Participant weight

Time frame: Baseline

Participant blood pressure

Time frame: Baseline

Participant heart rate

Time frame: Baseline

Participant Hypertrophic Cardiomyopathy (HCM) symptoms

Time frame: Baseline or index date, and up to 33 months

European participant CYP2C19 genotype

Time frame: Baseline or index date, and up to 33 months

Participant family history of Hypertrophic Cardiomyopathy (HCM)

Time frame: Baseline or index date

Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM)

Time frame: Baseline or index date

Participant family history of sudden cardiac death (SCD)

Time frame: Baseline or index date

Participant smoking status

Time frame: Baseline or index date

Participant alcohol use

Time frame: Baseline or index date

Participant recreational drug use

Time frame: Baseline or index date

Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT)

Time frame: Baseline or index date, and up to 33 months

Participant cardiovascular (CV) and CV-related comorbidities

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)

Time frame: Baseline and index date

Participant non-cardiovascular (CV)-related comorbidities

Including: * Anxiety/panic attacks * Asthma * COPD * Depression * Diabetes * Liver diseases

Time frame: Baseline or index date

Participant electrocardiogram (ECG) rhythm results

Time frame: Baseline or index date

Participant cardiac magnetic resonance imaging (MRI) results

Time frame: Baseline or index date

Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results

Time frame: Baseline or index date

Participant cardiac troponin results

Time frame: Baseline or index date

Participant cardiopulmonary exercise test (CPET) results

Time frame: Baseline or index date

Participant cardiac monitoring results

Time frame: Baseline or index date

Participant exercise test results

Time frame: Baseline or index date

Participant blood creatine levels

Time frame: Baseline or index date

Participant cardiovascular (CV) events

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

Time frame: Baseline

Type of procedures received by participants

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)

Time frame: Baseline or index date, and up to 33 months

Cardiovascular treatments prescribed to participants

Time frame: Baseline, and up to 33 months

Date of mavacamten prescription

Time frame: Baseline

Date of mavacamten treatment initiation

Time frame: Index date

Date of mavacamten dosage change

Time frame: Up to 33 months

Reason for mavacamten dosage change

Time frame: Up to 33 months

Occurrence of mavacamten stable dose (a period of 6-months with the same dose)

Time frame: Up to 33 months

Dates of follow-up after mavacamten treatment initiation

Time frame: Up to 33 months

Date of mavacamten treatment interuption or discontinuation

Time frame: Up to 33 months

Reason for mavacamten treatment interuption or discontinuation

Time frame: Up to 33 months

Supportive care provided to participants

Time frame: Up to 33 months

Heath care resource utilization (HCRU)

Time frame: Up to 33 months

Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation

Time frame: Up to 33 months

Secondary Outcomes

Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms

Time frame: Baseline and index date

Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM)

Time frame: Baseline, index date, and up to 33 months

Participant family history of sudden cardiac death (SCD)

Time frame: Baseline, index date, and up to 33 months

Cardiovascular (CV) and CV-related comorbidities

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)

Time frame: Baseline

Non-cardiovascular (non-CV) comorbidities

Including: * Anxiety/panic attacks * Asthma * COPD * Depression * Diabetes * Liver disease

Time frame: Baseline

Participant electrocardiogram (ECG) rhythm results

Time frame: Baseline

Participant echocardiogram (ECHO) results

Time frame: Baseline and index date

Participant cardiac MRI results

Time frame: Baseline

Participant NT-proBNP results

Time frame: Baseline

Participant cardiac tropin results

Time frame: Baseline

Participant cardiopulmonary exercise test (CPET) results

Time frame: Baseline

Participant cardiac monitoring results

Time frame: Baseline

Participant exercise test results

Time frame: Baseline

Hypertrophic Cardiomyopathy (HCM) subtype

Time frame: Baseline, index date, and up to 33 months

Participant symptoms at Hypertrophic Cardiomyopathy (HCM)

Time frame: Baseline, index date, and up to 33 months

Participant New York Heart Association (NYHA) class

Time frame: Baseline, index date, and up to 33 months

Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis

Time frame: Baseline

Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis

Time frame: Baseline