Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy (PREDICT-DCM)

University Hospital Heidelberg

Status: Unknown

Conditions: Cardiomyopathy, Dilated; Sudden Cardiac Death

Treatments: Diagnostic Test: Cardiac Magnetic Resonance Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT03224156

S-281/2017

Details and patient eligibility

About

PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.

Full description

Prophylactic ICD implantation was recently found to be non-beneficial over usual clinical care in non-ischemic systolic heart failure (LVEF≤35%) and 60-70% percent of SCD cases even occur in individuals with LEVF>35%. A growing evidence, that emphasizes the urgent need to improve the prediction of sudden cardiac death (SCD) in dilated cardiomyopathy (DCM).

CMR provides unique information on myocardial mechanics, fibrotic burden, inflammation and microvascular dysfunction, thereby allowing to quantify key substrates for myocardial arrhythmogenic potential.

PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.

Acquired candidate predictors are among others:

• Global and regional T1/T2
• T1/T2 inhomogeneity
• Extracellular volume fraction
• Microvascular dysfunction
• LA function and filling fraction
• Global and regional circumferential, radial or longitudinal myocardial strain
• Biomarkers

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dilated Cardiomyopathy
• ICD Indication
• age ≥ 18 years
• signed informed consent

Exclusion criteria

• severe claustrophobia
• rest dyspnea
• tachycardia or severe arrhythmia
• intolerance to gadolinium-based contrast agent

Trial design

150 participants in 1 patient group

Dilated Cardiomyopathy

Treatment:

Diagnostic Test: Cardiac Magnetic Resonance Imaging