NCT03224156

Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy

Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy: The PREDICT-DCM Trial.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Cardiomyopathy, Dilated
• Sudden Cardiac Death

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiac Magnetic Resonance Imaging	Patients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation.

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2017-07-21
• Last updated: 2017-07-27

Locations

2 sites across 1 country: Germany