Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction.

NCT ID: NCT01918215

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2025-08-31

Brief Summary

Contemporary heart failure (HF) guidelines recommend insertion of a primary prevention implantable defibrillator (ICD) in patients with left ventricular ejection fraction less than 35% (LVEF < 35%) on maximally tolerated medical therapy. Nevertheless, there are a substantial number of HF patients who have LVEF>35% and hence do not qualify for ICD, who succumb to sudden cardiac death (SCD). At present our tools to reliably risk stratify these patients with mild-moderate systolic dysfunction (LVEF 36-50%) are poor. It is likely that these patients have ventricular scar and/or replacement fibrosis as a substrate for their malignant arrhythmia. Cardiovascular magnetic resonance imaging (CMR) can reliably identify and quantify both ventricular scar (seen in Ischaemic cardiomyopathy, ICM) and replacement myocardial fibrosis (seen in Non-Ischemic Cardiomyopathy, NICM).

Methods/Design: A multi-centre randomised controlled trial in which 428 patients with mild-moderate left-ventricular systolic dysfunction (either ICM or NICM) and ventricular scar/fibrosis on cardiovascular magnetic resonance are randomized to either ICD or implantable loop recorder (ILR) insertion and are followed up until the last patient recruited has been in the study for 3 years.

Potentially eligible patients will have a screening CMR and will be enrolled into the device arm of study based on the presence of any ventricular scar/fibrosis (CMR +). Patients who do not have ventricular scar/fibrosis will be followed up in an observational registry, and will not be randomised.

In both the device and registry arms, we aim to enrol 700 patients in Australia and 355 in Europe.

The primary hypothesis is that among patients with mild-moderate left ventricular systolic dysfunction, a routine CMR guided management strategy of ICD insertion is superior to a conservative strategy of standard care.

Conditions

Heart Failure; Left Ventricular Systolic Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Device Implantation

A prospective, blocked, randomised, placebo-controlled trial of primary prophylaxis ICD therapy or implantable loop recorder (ILR) insertion in patients with LVEF 36-50% and Late Gadolinium Enhancement(LGE)on CMR

Group Type: OTHER

ICD

Intervention Type: DEVICE

ILR

Intervention Type: DEVICE

Observational Registry

A prospective observational registry of patients with LVEF 36-50% and no LGE on CMR

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ICD

Intervention Type: DEVICE

ILR

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age equal or greater than 18 years
• Patients with coronary artery disease (CAD) or dilated cardiomyopathy (DCM) of the idiopathic, chronic post myocarditis or familial type.
• Left ventricular systolic impairment as defined by left ventricular ejection fraction 36-50% by any current standard technique (echocardiogram, multiple gated acquisition scan (MUGA), angiography or CMR taken in the last six months. If a LGE CMR has been taken within 2 months this scan can be used for inclusion
• Able and willing to comply with all pre-, post- and follow-up testing, and requirements
• On maximum tolerated doses of ACE inhibitors (or Angiotensin and Receptor Blockers if intolerant of ACE) and Beta Blockers

Exclusion Criteria

1. History of cardiac arrest or spontaneous or inducible sustained ventricular tachycardia or ventricular fibrillation unless within 48 hours of an acute MI

2. Cardiomyopathy related to sarcoidosis

3. Standard Cardiac Magnetic Resonance imaging contraindications (e.g. severe claustrophobia)

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

5. Clinical indication for ICD or Pacemaker or cardiac resynchronisation therapy.

6. CMR LVEF ≤35% or>50%

7. Severe renal insufficiency (eGFR< 30mls/min/1.73m2)

8. Recent Myocardial Infarction (MI) (<40 days) or cardiac revascularization (<90 days)

9. New York Heart Association HF functional class IV at baseline

10. Conditions associated with life expectancy <1 year

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Australian Health and Medical Research Institute

OTHER

Sponsor Role: collaborator

Flinders University

OTHER

Sponsor Role: lead

Responsible Party

Joseph Selvanayagam

Professor Joseph Selvanayagam

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph B Selvanayagam, MBBS

Role: PRINCIPAL_INVESTIGATOR

Flinders Medical Centre

Locations

John Hunter Hospital

New Lambton, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

St Vincent's Hospital

Fitzroy, Victoria, Australia

The Alfred

Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Coburg Hospital

Coburg, , Germany

Schwarzwald-Baar Klinikum

Villingen-Schwenningen, , Germany

University Hospital Wurzburg

Würzburg, , Germany

Belfast Health and Social Care Trust

Belfast, , United Kingdom

The Bristol Heart Institute

Bristol, , United Kingdom

Golden Jubilee National Hospital

Clydebank, , United Kingdom

Glenfield General Hospital

Leicester, , United Kingdom

University Hospital of South Manchester NHS Foundation Trust

Manchester, , United Kingdom

Countries

Australia; Germany; United Kingdom

References

Selvanayagam JB, Hartshorne T, Billot L, Grover S, Hillis GS, Jung W, Krum H, Prasad S, McGavigan AD. Cardiovascular magnetic resonance-GUIDEd management of mild to moderate left ventricular systolic dysfunction (CMR GUIDE): Study protocol for a randomized controlled trial. Ann Noninvasive Electrocardiol. 2017 Jul;22(4):e12420. doi: 10.1111/anec.12420. Epub 2017 Jan 24.

Reference Type: DERIVED

PMID: 28117536 (View on PubMed)

Other Identifiers

CMRG-HF-1

Identifier Type: -

Identifier Source: org_study_id