Status:
UNKNOWN
Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction.
Lead Sponsor:
Flinders University
Collaborating Sponsors:
South Australian Health and Medical Research Institute
Conditions:
Heart Failure
Left Ventricular Systolic Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
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%) o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
449 Patients enrolled
Trial Details
Trial ID
NCT01918215
Start Date
July 1 2015
End Date
August 1 2025
Last Update
March 7 2023
Active Locations (18)
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1
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
2
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
3
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4029
4
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042