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

NCT01918215 | Unknown DMC

• 1 other identifier: CMRG-HF-1
• Study Type: interventional
• Target: 449
• Locations: 3 countries
• Sites: 18

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

Outcome Measures

Primary Outcomes (1)

• Composite of Sudden Cardiac Death or haemodynamically significant ventricular arrhythmia

  Defined as: ventricular arrhythmia producing syncope (loss of consciousness) or associated with hypotension (SBP\<90mmHg) except directly associated with device implant procedure.

  Through to study completion, an average of 4 years

Secondary Outcomes (8)

• Sudden Cardiac Death

  Through to study completion, an average of 4 years

• Haemodynamically significant ventricular arrhythmia

  Through to study completion, an average of 4 years

• All-cause mortality

  Through to study completion, an average of 4 years

• Change in New York Heart Association Functional class

  3, 6,12, 24, 36, 48 months

• Heart failure related hospitalizations

  Through to study completion, an average of 4 years

Study Arms (2)

Device Implantation

OTHER

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

Device: ICD; Device: ILR

Observational Registry

NO INTERVENTION

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

Interventions

ICD DEVICE

Device Implantation

ILR DEVICE

Device Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• History of cardiac arrest or spontaneous or inducible sustained ventricular tachycardia or ventricular fibrillation unless within 48 hours of an acute MI
• Cardiomyopathy related to sarcoidosis
• Standard Cardiac Magnetic Resonance imaging contraindications (e.g. severe claustrophobia)
• Currently implanted permanent pacemaker and/or pacemaker/ICD lead
• Clinical indication for ICD or Pacemaker or cardiac resynchronisation therapy.
• CMR LVEF ≤35% or\>50%
• Severe renal insufficiency (eGFR\< 30mls/min/1.73m2)
• Recent Myocardial Infarction (MI) (\<40 days) or cardiac revascularization (\<90 days)
• New York Heart Association HF functional class IV at baseline
• Conditions associated with life expectancy \<1 year
• Pregnancy or in females of child-bearing potential, the non-use of accepted forms of contraception

Sponsors & Collaborators

• Flinders University: lead
• South Australian Health and Medical Research Institute: collaborator

Study Sites (18)

John Hunter Hospital

New Lambton, New South Wales, 2305, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4029, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

The Alfred

Melbourne, Victoria, 3004, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Coburg Hospital

Coburg, 96450, Germany

Location

Schwarzwald-Baar Klinikum

Villingen-Schwenningen, 78052, Germany

Location

University Hospital Wurzburg

Würzburg, 97080, Germany

Location

Belfast Health and Social Care Trust

Belfast, BT12 6NT, United Kingdom

Location

The Bristol Heart Institute

Bristol, BS2 8HW, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, G814DY, United Kingdom

Location

Glenfield General Hospital

Leicester, LE39QP, United Kingdom

Location

University Hospital of South Manchester NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28117536 DERIVED

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Study Officials

• Joseph B Selvanayagam, MBBS

  Flinders Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Joseph Selvanayagam

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: August 7, 2013
• Study Start: July 1, 2015
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

DE (3); GB (5); AU (10)