mavaCamten ObservationaL evIdence Global cOnsortium in HCM (COLLIGO-HCM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 331
- 试验地点
- 2
- 主要终点
- Date of mavacamten prescription
研究概览
简要总结
COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Participants treated with mavacamten.
干预措施: Mavacamten (Drug)
Participants with Hypertrophic Cardiomyopathy (HCM)
Participants with an available HCM diagnosis date and without evidence of an HCM phenocopy
干预措施: Approved Hypertrophic Cardiomyopathy drug treatments (Drug)
结局指标
主要结局
Date of mavacamten prescription
时间窗: Baseline
Participant age at mavacamten treatment initiation
时间窗: Index date
Participant sex
时间窗: Baseline
Participant race/ethnicity
时间窗: Baseline
Participant exercise test results
时间窗: Baseline or index date
Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis
时间窗: Baseline or index date
Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis
时间窗: Baseline or index date
Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis
时间窗: Baseline or index date, and up to 33 months
Participant New York Heart Association (NYHA) class
时间窗: Baseline or index date, and up to 33 months
Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis
时间窗: Baseline
Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis
时间窗: Baseline
Participant height
时间窗: Baseline
Participant weight
时间窗: Baseline
Participant blood pressure
时间窗: Baseline
Participant heart rate
时间窗: Baseline
Participant Hypertrophic Cardiomyopathy (HCM) symptoms
时间窗: Baseline or index date, and up to 33 months
European participant CYP2C19 genotype
时间窗: Baseline or index date, and up to 33 months
Participant family history of Hypertrophic Cardiomyopathy (HCM)
时间窗: Baseline or index date
Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM)
时间窗: Baseline or index date
Participant family history of sudden cardiac death (SCD)
时间窗: Baseline or index date
Participant recreational drug use
时间窗: Baseline or index date
Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT)
时间窗: Baseline or index date, and up to 33 months
Participant cardiovascular (CV) and CV-related comorbidities
时间窗: 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
时间窗: Baseline, index date
Participant employment status
时间窗: Baseline
Participant educational level
时间窗: Baseline
Date of Hypertrophic Cardiomyopathy (HCM) diagnosis
时间窗: Baseline or index date
Participant blood creatine levels
时间窗: Baseline or index date
Participant insurance coverage
时间窗: Baseline
Participant cardiac troponin results
时间窗: Baseline or index date
Participant cardiopulmonary exercise test (CPET) results
时间窗: Baseline or index date
Participant smoking status
时间窗: Baseline or index date
Participant alcohol use
时间窗: Baseline or index date
Date of mavacamten dosage change
时间窗: Up to 33 months
Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation
时间窗: Up to 33 months
Participant non-cardiovascular (CV)-related comorbidities
时间窗: Baseline or index date
Including: * Anxiety/panic attacks * Asthma * COPD * Depression * Diabetes * Liver diseases
Participant cardiac magnetic resonance imaging (MRI) results
时间窗: Baseline or index date
Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results
时间窗: Baseline or index date
Participant cardiac monitoring results
时间窗: Baseline or index date
Participant cardiovascular (CV) events
时间窗: 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
Participant electrocardiogram (ECG) rhythm results
时间窗: Baseline or index date
Occurrence of mavacamten stable dose (a period of 6-months with the same dose)
时间窗: Up to 33 months
Dates of follow-up after mavacamten treatment initiation
时间窗: Up to 33 months
Date of mavacamten treatment interuption or discontinuation
时间窗: Up to 33 months
Reason for mavacamten treatment interuption or discontinuation
时间窗: Up to 33 months
Supportive care provided to participants
时间窗: Up to 33 months
Heath care resource utilization (HCRU)
时间窗: Up to 33 months
Reason for mavacamten dosage change
时间窗: Up to 33 months
Type of procedures received by participants
时间窗: 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
时间窗: Baseline, and up to 33 months
Date of mavacamten treatment initiation
时间窗: Index date
次要结局
- Participant exercise test results(Baseline)
- Hypertrophic Cardiomyopathy (HCM) subtype(Baseline, index date, and up to 33 months)
- Non-cardiovascular (non-CV) comorbidities(Baseline)
- 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)
- 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)