Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy (PREDICT-DCM)
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|ClinicalTrials.gov Identifier: NCT03224156|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 27, 2017
|Condition or disease||Intervention/treatment|
|Cardiomyopathy, Dilated Sudden Cardiac Death||Diagnostic Test: Cardiac Magnetic Resonance Imaging|
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
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy: The PREDICT-DCM Trial.|
|Estimated Study Start Date :||July 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Diagnostic Test: Cardiac Magnetic Resonance Imaging
Patients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation.
- Primary Combined Endpoint [ Time Frame: 18 months ]Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT
- Mortality [ Time Frame: 18 months ]Cardiac Death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224156
|Contact: Marco M Ochs, Dr. email@example.com|
|University Hospital Heidelberg, Krehl Klinik, Department of Cardiology||Recruiting|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Contact: Marco M Ochs, Dr. med.|
|GRN Hospital Weinheim||Not yet recruiting|
|Weinheim, Baden-Württemberg, Germany, 69469|
|Contact: Sorin Giusca, Dr. med.|