HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy.

HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy. - HCMR (2222/0003)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41965

Enrollment

140

Registered

2014-09-10

Start date

2014-12-30

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

enlargement of the heart thickness of heart muscle

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Male or Female, aged 18-65 • Established diagnosis of HCM defined as unexplained LVH defined as any segment >= 15mm thick • Signed informed consent • Able (in the investigator's opinion) and willing to comply with all study requirements

Exclusion criteria

Exclusion criteria: • Uncontrolled hypertension as judged by the investigator • Uncontrolled atrial fibrillation at time of enrollment • Angiographically documented >50% coronary stenosis • Prior septal myectomy or alcohol septal ablation • Prior myocardial infarction • Incessant ventricular arrhythmias • Diabetes with end organ damage • Stage IV/V chronic kidney disease (eGFR

Design outcomes

Primary

Measure	Time frame
Primary outcomes Using exploratory data mining methods to identify demographic, clinical, and novel cardiac magnetic resonance imaging, genetic and biomarker variables associated with the outcomes. Risk Markers 1. CMR to measure cardiac volumes, mass, function and fibrosis 2. Genotyping 3. Serum biomarkers of fibrosis 4. Clinical risk factors Clinical outcome Primary 1. The composite of cardiac death due to sudden cardiac death (SCD) and congestive heart failure (CHF) 2. Aborted SCD including appropriate intracardiac defibrillator (ICD) firing 3. Need for heart transplantation Secondary 1. All-cause mortality 2. Ventricular tachyarrhythmias 3. Hospitalisation for heart failure 4. Atrial fibrillation 5. Stroke	—

Measure

Time frame

Primary outcomes Using exploratory data mining methods to identify demographic, clinical, and novel cardiac magnetic resonance imaging, genetic and biomarker variables associated with the outcomes. Risk Markers 1. CMR to measure cardiac volumes, mass, function and fibrosis 2. Genotyping 3. Serum biomarkers of fibrosis 4. Clinical risk factors Clinical outcome Primary 1. The composite of cardiac death due to sudden cardiac death (SCD) and congestive heart failure (CHF) 2. Aborted SCD including appropriate intracardiac defibrillator (ICD) firing 3. Need for heart transplantation Secondary 1. All-cause mortality 2. Ventricular tachyarrhythmias 3. Hospitalisation for heart failure 4. Atrial fibrillation 5. Stroke

—

Secondary

Measure	Time frame
Secondary outcomes Using the demographic, clinical, imaging, biomarker and genetic measures, plus any interactions, identified in the tree analysis, Cox proportional hazards regression will be used to develop a predictive model.	—

Countries

Netherlands

Outcome results