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

Hypertrophic Cardiomyopathy (HCM) Clinical Trial

— COLLIGO-HCM  

Official title:

mavaCamten ObservationaL evIdence Global cOnsortium in HCM (COLLIGO-HCM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06372457
• Other study ID #: CV027-1107
• Status: Active, not recruiting
• Start date: December 1, 2023
• Est. completion date: June 15, 2025

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 15, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy (HCM)
• Hypertrophy

Intervention

Drug:
• Approved Hypertrophic Cardiomyopathy drug treatments
As per product label
• Mavacamten
As per product label

Locations

Country	Name	City	State
United States	IQVIA	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline, index date
Primary	Participant age at mavacamten treatment initiation		Index date
Primary	Participant sex		Baseline
Primary	Participant race/ethnicity		Baseline
Primary	Participant insurance coverage		Baseline
Primary	Participant employment status		Baseline
Primary	Participant educational level		Baseline
Primary	Date of Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline or index date
Primary	Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline or index date
Primary	Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis		Baseline or index date
Primary	Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline or index date, and up to 33 months
Primary	Participant New York Heart Association (NYHA) class		Baseline or index date, and up to 33 months
Primary	Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline
Primary	Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline
Primary	Participant height		Baseline
Primary	Participant weight		Baseline
Primary	Participant blood pressure		Baseline
Primary	Participant heart rate		Baseline
Primary	Participant Hypertrophic Cardiomyopathy (HCM) symptoms		Baseline or index date, and up to 33 months
Primary	European participant CYP2C19 genotype		Baseline or index date, and up to 33 months
Primary	Participant family history of Hypertrophic Cardiomyopathy (HCM)		Baseline or index date
Primary	Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM)		Baseline or index date
Primary	Participant family history of sudden cardiac death (SCD)		Baseline or index date
Primary	Participant smoking status		Baseline or index date
Primary	Participant alcohol use		Baseline or index date
Primary	Participant recreational drug use		Baseline or index date
Primary	Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT)		Baseline or index date, and up to 33 months
Primary	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)	Baseline and index date
Primary	Participant non-cardiovascular (CV)-related comorbidities	Including: Anxiety/panic attacks; Asthma; COPD; Depression; Diabetes; Liver diseases	Baseline or index date
Primary	Participant electrocardiogram (ECG) rhythm results		Baseline or index date
Primary	Participant cardiac magnetic resonance imaging (MRI) results		Baseline or index date
Primary	Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results		Baseline or index date
Primary	Participant cardiac troponin results		Baseline or index date
Primary	Participant cardiopulmonary exercise test (CPET) results		Baseline or index date
Primary	Participant cardiac monitoring results		Baseline or index date
Primary	Participant exercise test results		Baseline or index date
Primary	Participant blood creatine levels		Baseline or index date
Primary	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	Baseline
Primary	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)	Baseline or index date, and up to 33 months
Primary	Cardiovascular treatments prescribed to participants		Baseline, and up to 33 months
Primary	Date of mavacamten prescription		Baseline
Primary	Date of mavacamten treatment initiation		Index date
Primary	Date of mavacamten dosage change		Up to 33 months
Primary	Reason for mavacamten dosage change		Up to 33 months
Primary	Occurrence of mavacamten stable dose (a period of 6-months with the same dose)		Up to 33 months
Primary	Dates of follow-up after mavacamten treatment initiation		Up to 33 months
Primary	Date of mavacamten treatment interuption or discontinuation		Up to 33 months
Primary	Reason for mavacamten treatment interuption or discontinuation		Up to 33 months
Primary	Supportive care provided to participants		Up to 33 months
Primary	Heath care resource utilization (HCRU)		Up to 33 months
Primary	Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation		Up to 33 months
Secondary	Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms		Baseline and index date
Secondary	Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM)		Baseline, index date, and up to 33 months
Secondary	Participant family history of sudden cardiac death (SCD)		Baseline, index date, and up to 33 months
Secondary	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)	Baseline
Secondary	Non-cardiovascular (non-CV) comorbidities	Including: Anxiety/panic attacks; Asthma; COPD; Depression; Diabetes; Liver disease	Baseline
Secondary	Participant electrocardiogram (ECG) rhythm results		Baseline
Secondary	Participant echocardiogram (ECHO) results		Baseline and index date
Secondary	Participant cardiac MRI results		Baseline
Secondary	Participant NT-proBNP results		Baseline
Secondary	Participant cardiac tropin results		Baseline
Secondary	Participant cardiopulmonary exercise test (CPET) results		Baseline
Secondary	Participant cardiac monitoring results		Baseline
Secondary	Participant exercise test results		Baseline
Secondary	Hypertrophic Cardiomyopathy (HCM) subtype		Baseline, index date, and up to 33 months
Secondary	Participant symptoms at Hypertrophic Cardiomyopathy (HCM)		Baseline, index date, and up to 33 months
Secondary	Participant New York Heart Association (NYHA) class		Baseline, index date, and up to 33 months
Secondary	Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline
Secondary	Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis		Baseline

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls