Routine vs Selective Cardiac Magnetic Resonance in Non-Ischemic Heart Failure (OUTSMART)
Heart Failure
About this trial
This is an interventional other trial for Heart Failure focused on measuring cardiac magnetic resonance imaging, echocardiography, heart failure, imaging, cost effectiveness, quality of life, definitive diagnosis, prospective comparative effectiveness randomized clinical trial
Eligibility Criteria
The study population includes patients with either
Newly diagnosed HF within the past 12 months
OR
- Established HF patients with deterioration/decompensation within the past 12 months
Inclusion Criteria: Patients with new or worsening HF as above AND
- Age > 18
- Working clinical diagnosis (known or highly suspected) of non-ischemic cardiomyopathy (NICM) OR Clinical diagnosis of HFPEF (Signs or symptoms of heart failure with a LVEF ≥ 40%)
- Documented history of Class II-IV NYHA HF symptoms within the past 12 months
Exclusion Criteria:
- Prior CMR and no major change in clinical condition
- Well-documented specific etiology (eg known amyloidosis or hemochromatosis)
- MD considers cause of heart failure is attributable to obstructive CAD.
- Documented previous STEMI (any territory) or NSTEMI in LAD territory
- Severe medical conditions that significantly affect the patient's outcome (eg. active malignancy)
- Ongoing need for advanced cardiac life support (eg IABP)
- Severe valvular heart disease requiring surgery within the next 6 months
- Contraindications to CMR (e.g. certain metallic implants, severe claustrophobia)
- Contraindications to gadolinium contrast agent (GFR < 30ml/min/1,72m2, pregnancy)
- Inability to give informed consent
- Evidence of multivessel ischemia on stress imaging
Sites / Locations
- University of Calgary
- University of Alberta
- Dalhousie University
- Hamilton Health Sciences Centre
- London Health Sciences Centre
- University of Ottawa Heart Institute
- St. Michael's Hospital
- Sunnybrook Health Sciences Centre
- Montreal Heart Institute
- University of Laval
- Université de Sherbrooke
- Helsinki University Central Hospital,
- University of Kuopio
- University of Turku
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Standard imaging (echocardiography)
Advanced Imaging (Cardiac MRI)
Subjects will undergo their clinically indicated echocardiogram as ordered by their attending physician.
Subjects will undergo their clinically indicated echo as ordered by their attending physician, plus a cardiac MRI, which will be scheduled within 14 days of the echo.