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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
Sponsor:
Information provided by (Responsible Party):
Marco Ochs, 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.

Condition or disease Intervention/treatment
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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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


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




Primary Outcome Measures :
  1. Primary Combined Endpoint [ Time Frame: 18 months ]
    Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 18 months ]
    Cardiac Death



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Dilated Cardiomyopathy prior to ICD-implantation.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Marco M Ochs, Dr. med. 00496221-568611 marco.ochs@med.uni-heidelberg.de

Locations
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Germany
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.         
Sponsors and Collaborators
University Hospital Heidelberg

Additional Information:
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Responsible Party: Marco Ochs, Dr. med. Marco Ochs, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03224156     History of Changes
Other Study ID Numbers: S-281/2017
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cardiomyopathies
Death
Cardiomyopathy, Dilated
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiomegaly
Heart Arrest
Death, Sudden