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Trial record 1 of 1 for:    NCT01918215
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Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction. (CMR_GUIDE)

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ClinicalTrials.gov Identifier: NCT01918215
Recruitment Status : Recruiting
First Posted : August 7, 2013
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
South Australian Health and Medical Research Institute
Information provided by (Responsible Party):
Joseph Selvanayagam, Flinders University

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.


Condition or disease Intervention/treatment Phase
Heart Failure Left Ventricular Systolic Dysfunction Device: ICD Device: ILR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1055 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction
Actual Study Start Date : July 2015
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Arm Intervention/treatment
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
Device: ICD
Device: ILR
No Intervention: Observational Registry
A prospective observational registry of patients with LVEF 36-50% and no LGE on CMR



Primary Outcome Measures :
  1. Composite of Sudden Cardiac Death or haemodynamically significant ventricular arrhythmia [ Time Frame: Through to study completion, an average of 4 years ]
    Defined as: ventricular arrhythmia producing syncope (loss of consciousness) or associated with hypotension (SBP<90mmHg) except directly associated with device implant procedure.


Secondary Outcome Measures :
  1. Sudden Cardiac Death [ Time Frame: Through to study completion, an average of 4 years ]
  2. Haemodynamically significant ventricular arrhythmia [ Time Frame: Through to study completion, an average of 4 years ]
  3. All-cause mortality [ Time Frame: Through to study completion, an average of 4 years ]
  4. Change in New York Heart Association Functional class [ Time Frame: 3, 6,12, 24, 36, 48 months ]
  5. Heart failure related hospitalizations [ Time Frame: Through to study completion, an average of 4 years ]
  6. Health economic evaluation of cost [ Time Frame: At study completion, average of 4 years ]
    Australia only

  7. Quality of life assessed by Minnesota Living with Heart Failure Questionnaire [ Time Frame: 3, 6,12, 24, 36, 48 months ]
  8. Quality of life assessed by EuroQol-5D-5L questionnaire [ Time Frame: 3, 6,12, 24, 36, 48 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918215


Contacts
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Contact: Joseph B Selvanayagam, MBBS +61 8 8404 2195 joseph.selvanayagam@flinders.edu.au

Locations
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Sponsors and Collaborators
Flinders University
South Australian Health and Medical Research Institute
Investigators
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Principal Investigator: Joseph B Selvanayagam, MBBS Flinders Medical Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joseph Selvanayagam, Professor Joseph Selvanayagam, Flinders University
ClinicalTrials.gov Identifier: NCT01918215    
Other Study ID Numbers: CMRG-HF-1
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction