COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Interventions
- Drug: Approved Hypertrophic Cardiomyopathy drug treatments
- Registration Number
- NCT06372457
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
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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
• 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Hypertrophic Cardiomyopathy (HCM) Approved Hypertrophic Cardiomyopathy drug treatments Participants with an available HCM diagnosis date and without evidence of an HCM phenocopy Participants treated with mavacamten. Mavacamten -
- Primary Outcome Measures
Name Time Method Participant smoking status Baseline or index date Participant alcohol use Baseline or index date Participant age at mavacamten treatment initiation Index date Participant sex Baseline Participant race/ethnicity Baseline Participant heart rate Baseline 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 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 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 age at Hypertrophic Cardiomyopathy (HCM) diagnosis Baseline, index date Participant employment status Baseline Participant educational level Baseline Date of Hypertrophic Cardiomyopathy (HCM) diagnosis Baseline or index date Participant insurance coverage Baseline Participant cardiac troponin results Baseline or index date Participant cardiopulmonary exercise test (CPET) results Baseline or index date Participant exercise test results Baseline or index date Participant blood creatine levels Baseline or index date Date of mavacamten dosage change Up to 33 months Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation Up to 33 months Participant non-cardiovascular (CV)-related comorbidities Baseline or index date Including:
* Anxiety/panic attacks
* Asthma
* COPD
* Depression
* Diabetes
* Liver diseasesParticipant 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 monitoring results 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
* SyncopeParticipant electrocardiogram (ECG) rhythm results Baseline or index date Date of mavacamten prescription Baseline 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 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 treatment initiation Index date Reason for mavacamten dosage change Up to 33 months
- Secondary Outcome Measures
Name Time Method Participant exercise test results Baseline Hypertrophic Cardiomyopathy (HCM) subtype Baseline, index date, and up to 33 months Non-cardiovascular (non-CV) comorbidities Baseline Including:
* Anxiety/panic attacks
* Asthma
* COPD
* Depression
* Diabetes
* Liver diseaseParticipant 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)Participant electrocardiogram (ECG) rhythm results Baseline 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 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 symptoms at Hypertrophic Cardiomyopathy (HCM) Baseline, index date, and up to 33 months Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis Baseline
Trial Locations
- Locations (1)
IQVIA
🇺🇸Durham, North Carolina, United States