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

Sponsor

University Hospital Heidelberg (Other)

Overall Status

Unknown status

CT.gov ID

NCT03224156

Collaborator

(none)

150

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathy, Dilated Sudden Cardiac Death	Diagnostic Test: Cardiac Magnetic Resonance Imaging

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2017

Anticipated Primary Completion Date :

Jul 1, 2019

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Dilated Cardiomyopathy	Diagnostic Test: Cardiac Magnetic Resonance Imaging Patients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation.

Arm

Intervention/Treatment

Dilated Cardiomyopathy

Diagnostic Test: Cardiac Magnetic Resonance Imaging

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

Outcome Measures

Primary Outcome Measures

Primary Combined Endpoint [18 months]
Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT

Secondary Outcome Measures

Mortality [18 months]
Cardiac Death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Heidelberg, Krehl Klinik, Department of Cardiology	Heidelberg	Baden-Württemberg	Germany	69120
2	GRN Hospital Weinheim	Weinheim	Baden-Württemberg	Germany	69469

Sponsors and Collaborators

University Hospital Heidelberg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

University Hospital Heidelberg

Publications

None provided.

Responsible Party:

Marco Ochs, Dr. med. Marco Ochs, University Hospital Heidelberg

ClinicalTrials.gov Identifier:

NCT03224156

Other Study ID Numbers:

S-281/2017

First Posted:

Jul 21, 2017

Last Update Posted:

Jul 27, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiomyopathies

Cardiomyopathy, Dilated

Death, Sudden, Cardiac

Death

Study Results

No Results Posted as of Jul 27, 2017