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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03224156
Other study ID # S-281/2017
Secondary ID
Status Recruiting
Phase N/A
First received July 18, 2017
Last updated July 25, 2017
Start date July 2017
Est. completion date July 2019

Study information

Verified date July 2017
Source University Hospital Heidelberg
Contact Marco M Ochs, Dr. med.
Phone 00496221-568611
Email marco.ochs@med.uni-heidelberg.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Intervention

Diagnostic Test:
Cardiac Magnetic Resonance Imaging
Patients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation.

Locations

Country Name City State
Germany University Hospital Heidelberg, Krehl Klinik, Department of Cardiology Heidelberg Baden-Württemberg
Germany GRN Hospital Weinheim Weinheim Baden-Württemberg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

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