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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01918215

Registration number

NCT01918215

Ethics application status

Date submitted

19/04/2013

Date registered

7/08/2013

Date last updated

7/03/2023

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

CMRG-HF-1

Universal Trial Number (UTN)

Trial acronym

CMR_GUIDE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Heart Failure

Left Ventricular Systolic Dysfunction

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Other: 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

No intervention: Observational Registry - A prospective observational registry of patients with LVEF 36-50% and no LGE on CMR

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Composite of Sudden Cardiac Death or haemodynamically significant ventricular arrhythmia

Timepoint [1]

Through to study completion, an average of 4 years

Secondary outcome [1]

Sudden Cardiac Death

Timepoint [1]

Through to study completion, an average of 4 years

Secondary outcome [2]

Haemodynamically significant ventricular arrhythmia

Timepoint [2]

Through to study completion, an average of 4 years

Secondary outcome [3]

All-cause mortality

Timepoint [3]

Through to study completion, an average of 4 years

Secondary outcome [4]

Change in New York Heart Association Functional class

Timepoint [4]

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

Secondary outcome [5]

Heart failure related hospitalizations

Timepoint [5]

Through to study completion, an average of 4 years

Secondary outcome [6]

Health economic evaluation of cost

Timepoint [6]

At study completion, average of 4 years

Secondary outcome [7]

Quality of life assessed by Minnesota Living with Heart Failure Questionnaire

Timepoint [7]

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

Secondary outcome [8]

Quality of life assessed by EuroQol-5D-5L questionnaire

Timepoint [8]

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

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/07/2015

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/08/2025

Actual

Sample size

Target

Accrual to date

Final

449

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,TAS,VIC,WA

Recruitment hospital [1]

John Hunter Hospital - New Lambton

Recruitment hospital [2]

Princess Alexandra Hospital - Brisbane

Recruitment hospital [3]

Royal Brisbane & Women's Hospital - Herston

Recruitment hospital [4]

Flinders Medical Centre - Bedford Park

Recruitment hospital [5]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment hospital [6]

Royal Hobart Hospital - Hobart

Recruitment hospital [7]

St Vincent's Hospital - Fitzroy

Recruitment hospital [8]

The Alfred - Melbourne

Recruitment hospital [9]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [10]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

2305 - New Lambton

Recruitment postcode(s) [2]

4102 - Brisbane

Recruitment postcode(s) [3]

4029 - Herston

Recruitment postcode(s) [4]

5042 - Bedford Park

Recruitment postcode(s) [5]

5112 - Elizabeth Vale

Recruitment postcode(s) [6]

7000 - Hobart

Recruitment postcode(s) [7]

3065 - Fitzroy

Recruitment postcode(s) [8]

3004 - Melbourne

Recruitment postcode(s) [9]

6009 - Nedlands

Recruitment postcode(s) [10]

6000 - Perth

Recruitment outside Australia

Country [1]

Germany

State/province [1]

Coburg

Country [2]

Germany

State/province [2]

Villingen-Schwenningen

Country [3]

Germany

State/province [3]

Wurzburg

Country [4]

United Kingdom

State/province [4]

Belfast

Country [5]

United Kingdom

State/province [5]

Bristol

Country [6]

United Kingdom

State/province [6]

Clydebank

Country [7]

United Kingdom

State/province [7]

Leicester

Country [8]

United Kingdom

State/province [8]

Manchester

Funding & Sponsors

Primary sponsor type

Other

Name

Flinders University

Address

Country

Other collaborator category [1]

Other

Name [1]

South Australian Health and Medical Research Institute

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT01918215

Trial related presentations / publications

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.

Public notes

Contacts

Principal investigator

Name

Joseph B Selvanayagam, MBBS

Address

Flinders Medical Centre

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01918215

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01918215