Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy

NCT ID: NCT03224156

Last Updated: 2017-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cardiomyopathy, Dilated Sudden Cardiac Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dilated Cardiomyopathy

Cardiac Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Cardiac Magnetic Resonance Imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Marco Ochs

Dr. med. Marco Ochs

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Heidelberg, Krehl Klinik, Department of Cardiology

Heidelberg, Baden-Wurttemberg, Germany

Site Status RECRUITING

GRN Hospital Weinheim

Weinheim, Baden-Wurttemberg, Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Marco M Ochs, Dr. med.

Role: CONTACT

00496221-568611

Facility Contacts

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Marco M Ochs, Dr. med.

Role: primary

Sorin Giusca, Dr. med.

Role: primary

Related Links

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Other Identifiers

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S-281/2017

Identifier Type: -

Identifier Source: org_study_id

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