Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy

Sudden Cardiac Death Clinical Trial

— PREDICT-DCM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03224156
• Other study ID #: S-281/2017
• 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
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

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

External Links

•   University Hospital Heidelberg