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Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy

ConditionsDilated CardiomyopathyLeft Ventricular Systolic DysfunctionFibrosis Myocardial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlinders University

About this trial

CMR GUIDE DCM is a randomized controlled trial with a registry for non-randomized patients.

Patients enrolled will have non-ischemic cardiomyopathy (NICM) with mild to severe Left Ventricular (LV) systolic dysfunction with replacement fibrosis identified on Cardiac Magnetic Resonance (CMR).

954 patients will be randomised from 50 sites across 4-6 countries worldwide to receive an implantable defibrillator (ICD) or implantable loop recorder (ILR).

Device and clinical follow-up will be performed at 3, 6, 12, 24, 36 months and at end of study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than/equal to 18 years old

Non-ischemic cardiomyopathy of dilated type

Left Ventricular Ejection Fraction < 45%

Able and willing to comply with all pre, post and follow-up testing and requirements

Disqualifiers

Known coronary artery disease (CAD) (History of Myocardial Infarction or Significant Epicardial CAD on Angiography)

Hypertrophic Cardiomyopathy

Cardiomyopathy related to sarcoidosis

Arrhythmogenic Right Ventricular Dysplasia

Trial design

Design model

Parallel

Treatments tested in this trial

  • ICD

    Device

    Insertion of ICD in patients with LVEF \<45% and LGE on CMR.

  • ILR

    Device

    Insertion of ILR in patients with LVEF \<45% and LGE on CMR.

Treatment groups

1,880 Participants
are divided into 2 treatment groups
Group A: Device ImplantationOther 2 interventions
Group B: Observational RegistryNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

All-Cause Mortality

Time frame
Through to study completion, an average of 4 years

Secondary outcomes

1

Number of Participants who have Sudden Cardiac Death

Time frame
Through to study completion, an average of 4 years
2

Number of Participants who have a Haemodynamically significant ventricular arrhythmia event

Time frame
Through to study completion, an average of 4 years
3

Quality of life assessed by Kansas City Cardiomyopathy Questionnaire

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the above 23 items which will be between 0-100. A higher score reflects a better health status.

Time frame
Measured at 3, 6, 12, 24, 36 months through to study completion
4

Number of Participants who have a Heart Failure related hospitalisation

Time frame
Through to study completion, an average of 4 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Flinders University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: