Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03224156

Acronym

PREDICT-DCM

Enrollment

150

Registered

2017-07-21

Start date

2017-07-31

Completion date

2019-07-31

Last updated

2017-07-27

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

Conditions

Cardiomyopathy, Dilated, Sudden Cardiac Death

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

Interventions

DIAGNOSTIC_TESTCardiac Magnetic Resonance Imaging

Patients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Combined Endpoint	18 months	Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT

Secondary

Measure	Time frame	Description
Mortality	18 months	Cardiac Death

Countries

Germany

Contacts

Primary ContactMarco M Ochs, Dr. med.

marco.ochs@med.uni-heidelberg.de00496221-568611

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026