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

Dilated Cardiomyopathy Clinical Trial

— CMR GUIDE DCM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03993730
• Other study ID #: CMRG-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: June 2026

Study information

• Verified date: June 2019
• Source: Flinders University
• Contact: Joseph B Selvanayagam, MBBS
• Phone: +61 8 8404 2195
• Email: joseph.selvanayagam[@]flinders.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The planned research will have two components: A prospective, blocked, randomized, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and Late Gadolinium Enhancement (LGE) on CMR and

A prospective observational registry of patients with LVEF <45% and no LGE on CMR. Registry patients will not have an intervention but will have the same follow up frequency as the randomized patients.

The Primary objective is to determine if routine CMR guided management strategy of implantable defibrillator (ICD) insertion reduces total mortality compared to a conservative strategy of implantable loop recorder (ILR) insertion and standard care.

The secondary objectives include:

• To determine if routine CMR guided management strategy of ICD insertion reduces sudden cardiac death (SCD) compared to a conservative strategy of ILR insertion and standard care.

• To ascertain the rate of SCD in patients with DCM and LGE scar across a wide range of left ventricular ejection fraction (LVEF).

Statistical analysis will be performed on an intention-to-treat basis. The main analysis of time to death from any cause will be performed using a log- rank test.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1880
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• On maximum tolerated doses of angiotensin converting enzyme (ACE) inhibitors (or Angiotensin Receptor Blockers(ARB) or Neprilysin Inhibitors) and Beta Blockers

Exclusion Criteria:

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

2. Hypertrophic Cardiomyopathy

3. Cardiomyopathy related to sarcoidosis

4. Arrhythmogenic Right Ventricular Dysplasia

5. Standard LGE CMR contraindications (e.g. severe claustrophobia, metal)

6. Currently implanted permanent pacemaker and/or pacemaker/ICD lead

7. Clinical indication for ICD or pacemaker or Cardiac Resynchronisation Therapy

8. Contraindications to intravenous Gadolinium

9. Severe renal insufficiency (eGFR< 45mls/min/1.73m2 )

10. New York Heart Association Heart Failure functional class IV

11. Conditions associated with life expectancy <1 year

12. Pregnancy or in females of child-bearing potential, the non-use of accepted forms of contraception

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Fibrosis Myocardial
• Left Ventricular Systolic Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• ICD
Insertion of ICD in patients with LVEF <45% and LGE on CMR.
• ILR
Insertion of ILR in patients with LVEF <45% and LGE on CMR.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Flinders University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause Mortality		Through to study completion, an average of 4 years
Secondary	Number of Participants who have Sudden Cardiac Death		Through to study completion, an average of 4 years
Secondary	Number of Participants who have a Haemodynamically significant ventricular arrhythmia event		Through to study completion, an average of 4 years
Secondary	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.	Measured at 3, 6, 12, 24, 36 months through to study completion
Secondary	Number of Participants who have a Heart Failure related hospitalisation		Through to study completion, an average of 4 years
Secondary	Health economic evaluation of cost	Various different country jurisdictions will be chosen	At study completion, an average of 4 years