Clinical trial NCT06372457: COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Official title: mavaCamten ObservationaL evIdence Global cOnsortium in HCM (COLLIGO-HCM)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertrophic Cardiomyopathy (HCM)
Keywords: mavacamten, oHCM, cardiac myosin inhibitor, NYHA class, echocardiogram parameters, patient-reported outcomes
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult patients who have been diagnosed with Hypertrophic Cardiomyopathy (HCM).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis
timeFrame: Baseline, index date
measure: Participant age at mavacamten treatment initiation
timeFrame: Index date
measure: Participant sex
timeFrame: Baseline
measure: Participant race/ethnicity
timeFrame: Baseline
measure: Participant insurance coverage
timeFrame: Baseline
measure: Participant employment status
timeFrame: Baseline
measure: Participant educational level
timeFrame: Baseline
measure: Date of Hypertrophic Cardiomyopathy (HCM) diagnosis
timeFrame: Baseline or index date
measure: Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis
timeFrame: Baseline or index date
measure: Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis
timeFrame: Baseline or index date
measure: Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis
timeFrame: Baseline or index date, and up to 33 months
measure: Participant New York Heart Association (NYHA) class
timeFrame: Baseline or index date, and up to 33 months
measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis
timeFrame: Baseline
measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis
timeFrame: Baseline
measure: Participant height
timeFrame: Baseline
measure: Participant weight
timeFrame: Baseline
measure: Participant blood pressure
timeFrame: Baseline
measure: Participant heart rate
timeFrame: Baseline
measure: Participant Hypertrophic Cardiomyopathy (HCM) symptoms
timeFrame: Baseline or index date, and up to 33 months
measure: European participant CYP2C19 genotype
timeFrame: Baseline or index date, and up to 33 months
measure: Participant family history of Hypertrophic Cardiomyopathy (HCM)
timeFrame: Baseline or index date
measure: Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM)
timeFrame: Baseline or index date
measure: Participant family history of sudden cardiac death (SCD)
timeFrame: Baseline or index date
measure: Participant smoking status
timeFrame: Baseline or index date
measure: Participant alcohol use
timeFrame: Baseline or index date
measure: Participant recreational drug use
timeFrame: Baseline or index date
measure: Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT)
timeFrame: Baseline or index date, and up to 33 months
measure: Participant cardiovascular (CV) and CV-related comorbidities
timeFrame: Baseline and index date
measure: Participant non-cardiovascular (CV)-related comorbidities
timeFrame: Baseline or index date
measure: Participant electrocardiogram (ECG) rhythm results
timeFrame: Baseline or index date
measure: Participant cardiac magnetic resonance imaging (MRI) results
timeFrame: Baseline or index date
measure: Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results
timeFrame: Baseline or index date
measure: Participant cardiac troponin results
timeFrame: Baseline or index date
measure: Participant cardiopulmonary exercise test (CPET) results
timeFrame: Baseline or index date
measure: Participant cardiac monitoring results
timeFrame: Baseline or index date
measure: Participant exercise test results
timeFrame: Baseline or index date
measure: Participant blood creatine levels
timeFrame: Baseline or index date
measure: Participant cardiovascular (CV) events
timeFrame: Baseline
measure: Type of procedures received by participants
timeFrame: Baseline or index date, and up to 33 months
measure: Cardiovascular treatments prescribed to participants
timeFrame: Baseline, and up to 33 months
measure: Date of mavacamten prescription
timeFrame: Baseline
measure: Date of mavacamten treatment initiation
timeFrame: Index date
measure: Date of mavacamten dosage change
timeFrame: Up to 33 months
measure: Reason for mavacamten dosage change
timeFrame: Up to 33 months
measure: Occurrence of mavacamten stable dose (a period of 6-months with the same dose)
timeFrame: Up to 33 months
measure: Dates of follow-up after mavacamten treatment initiation
timeFrame: Up to 33 months
measure: Date of mavacamten treatment interuption or discontinuation
timeFrame: Up to 33 months
measure: Reason for mavacamten treatment interuption or discontinuation
timeFrame: Up to 33 months
measure: Supportive care provided to participants
timeFrame: Up to 33 months
measure: Heath care resource utilization (HCRU)
timeFrame: Up to 33 months
measure: Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation
timeFrame: Up to 33 months
Secondary outcomes:
measure: Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms
timeFrame: Baseline and index date
measure: Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM)
timeFrame: Baseline, index date, and up to 33 months
measure: Participant family history of sudden cardiac death (SCD)
timeFrame: Baseline, index date, and up to 33 months
measure: Cardiovascular (CV) and CV-related comorbidities
timeFrame: Baseline
measure: Non-cardiovascular (non-CV) comorbidities
timeFrame: Baseline
measure: Participant electrocardiogram (ECG) rhythm results
timeFrame: Baseline
measure: Participant echocardiogram (ECHO) results
timeFrame: Baseline and index date
measure: Participant cardiac MRI results
timeFrame: Baseline
measure: Participant NT-proBNP results
timeFrame: Baseline
measure: Participant cardiac tropin results
timeFrame: Baseline
measure: Participant cardiopulmonary exercise test (CPET) results
timeFrame: Baseline
measure: Participant cardiac monitoring results
timeFrame: Baseline
measure: Participant exercise test results
timeFrame: Baseline
measure: Hypertrophic Cardiomyopathy (HCM) subtype
timeFrame: Baseline, index date, and up to 33 months
measure: Participant symptoms at Hypertrophic Cardiomyopathy (HCM)
timeFrame: Baseline, index date, and up to 33 months
measure: Participant New York Heart Association (NYHA) class
timeFrame: Baseline, index date, and up to 33 months
measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis
timeFrame: Baseline
measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis
timeFrame: Baseline
Other outcomes:
Locations:
city: Durham
country: United States
facility: IQVIA
state: North Carolina
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: