Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy

• Conditions: Cardiomyopathy, Dilated; Sudden Cardiac Death
• Interventions: Diagnostic Test: Cardiac Magnetic Resonance Imaging

• Registration Number: NCT03224156
• Lead Sponsor: University Hospital Heidelberg

Brief 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

Study Timeline

• Status Verified: 2017-07
• Study Start: 2017-07
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-27
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dilated Cardiomyopathy	Cardiac Magnetic Resonance Imaging	-

Primary Outcome Measures

Name	Time	Method
Primary Combined Endpoint	18 months	Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT

Secondary Outcome Measures

Name	Time	Method
Mortality	18 months	Cardiac Death

Trial Locations

Locations (2)

University Hospital Heidelberg, Krehl Klinik, Department of Cardiology; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

GRN Hospital Weinheim; 🇩🇪 Weinheim, Baden-Württemberg, Germany