Routine vs Selective Cardiac Magnetic Resonance in Non-Ischemic Heart Failure (OUTSMART)
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| ClinicalTrials.gov Identifier: NCT01281384 |
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Recruitment Status :
Completed
First Posted : January 21, 2011
Last Update Posted : November 21, 2019
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Uncovering the underlying cause of heart failure can be quite challenging and doctors often rely on imaging tests such as echo (heart ultrasound) to provide the answers. Cardiac MRI is emerging as another promising test because it gives very precise information on heart function and the amount of scarring in the muscle. Heart failure patients are increasingly being sent for cardiac MRI but the potential advantage that this test offers over others such as echo has not been fully explored.
The purpose of this study is to determine if cardiac MRI provides more information on the cause of heart failure than traditional tests such as echo. In addition, if the information provided by this test always leads to an overall improvement in a patient's heart condition over time.
This is a randomized study where subjects referred for clinically indicated heart failure workup to determine the best clinical management will undergo standard heart failure testing (including echo) OR standard testing PLUS cardiac MRI.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure | Other: Advanced Imaging Other: Standard Imaging | Not Applicable |
Primary objective: to compare the effect of routine cardiac magnetic resonance (CMR) versus standard care (i.e. echocardiography with only selective use of CMR) on the etiological diagnosis in patients with a non-ischemic heart failure (HF). The proposed categories of HF to be considered in this study include: idiopathic dilated cardiomyopathy, infiltrative cardiomyopathy, inflammatory, hypertrophic cardiomyopathy, heart failure with preserved ejection fraction (HFPEF), ischemic cardiomyopathy, mixed etiology and other (eg. pericardial, congenital, non-compaction, right ventricular failure).
Primary hypothesis: Routine use of CMR (vs. selective use) will lead to a more specific diagnostic characterization of the underlying etiology of non-ischemic heart failure. This will lead to a reduction in the diagnosis of idiopathic dilated cardiomyopathy and HFPEF.
Secondary objectives: Determine the effects that routine use of CMR in non-ischemic HF has on therapeutic decisions, on the Composite Clinical Endpoint (CCE), cardiac function, symptoms, quality of life (QoL), and costs. Ancillary measurements will include the safety of imaging tests and adverse reactions to gadolinium contrast agent.
Secondary hypothesis: Routine use of CMR will have significant impact on treatment decisions, (1) lead to more disease specific therapies and/or (2) cause a significant change in the number and class of HF meds, during follow-up. The routine CMR group will also have improved clinical outcomes (CCE), symptoms and QoL and decreased costs to the standard of care group during follow-up.
Design
Methods: Randomized controlled trial comparing i) routine CMR vs. ii) echocardiography with selective CMR in patient with HF due to NICM and/or HFPEF.
Among patients enrolled in Level I of IMAGE-HF, it is expected that 504 will have known NICM (or strongly suspected based on young age, absent risk factors and presenting history) and/or HFPEF.
Tertiary care sites (in Canada and Finland) with dedicated HF programs will participate in the study. Consecutive patients will be enrolled at sites with dedicated CMR programs (defined as minimum 200 cases/year and maximum 2 weeks waiting time in the majority of patients) and randomized to routine CMR or selective CMR. Non-ischemic HF patients from sites without dedicated CMR programs will be included in a registry of patients undergoing routine HF care (i.e. selective use of CMR). Participants in the selective CMR arm may ONLY undergo CMR for a suspicion of: 1) infiltrative myocardial disease, 2) arrhythmogenic right ventricular cardiomyopathy, 3) adult congenital heart disease or 4) pericardial disease following standard HF care including echocardiography. Other tertiary sites may be added in year 2-3 depending on recruitment needs and registry sites may become randomization sites if the experience and wait-time criteria are met.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 518 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Routine vs Selective Cardiac Magnetic Resonance in Non-Ischemic Heart Failure (OUTSMART-HF) Project I-B of Imaging Modalities to Assist With Guiding Therapy and the Evaluation of Patients With Heart Failure (IMAGE-HF) |
| Study Start Date : | January 2011 |
| Actual Primary Completion Date : | December 31, 2017 |
| Actual Study Completion Date : | December 31, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard imaging (echocardiography)
Subjects will undergo their clinically indicated echocardiogram as ordered by their attending physician.
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Other: Standard Imaging
Other Name: Echocardiography |
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Active Comparator: Advanced Imaging (Cardiac MRI)
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.
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Other: Advanced Imaging
Other Name: Cardiac Magnetic Resonance Imaging (CMR) |
- Frequency of definitive diagnoses [ Time Frame: 3 and 12 months ]
Following the completion of all baseline testing (including echo) in the selective arm and baseline testing + CMR in the routine arm, the treating physician will assign a diagnosis on a standardized template using all available information. The diagnosis of non-ischemic cardiomyopathies will be based upon recent Canadian Consensus Statement.
Expected Result - The routine CMR group will have a significantly higher rate of specific diagnoses for (a) heart failure with preserved systolic function (HFPSF) and (b) dilated cardiomyopathy (DCM) diagnoses (i.e. fewer idiopathic DCM) than the selective CMR group.
- Treatment effects [ Time Frame: 3 and 12 months ]Telephone follow up will be conducted. The presence of each HF medication class will be re-assessed in addition to the overall number of cardiac medications. The presence of advanced HF therapies will additionally be recorded at each follow-up visit including: implantable device, electrophysiologic study/ablation, cardiac surgery/transplantation, and disease specific therapies (eg. phlebotomy for hemochromatosis; steroids for sarcoidosis). The HF specialist supervising the follow-up visits will also be asked to reassess the HF etiology during each encounter.
- Clinical Endpoints [ Time Frame: 3 and 12 months ]CCE (Death, Cardiovascular (CV) death, HF admission), left ventricular (LV) Function, QoL, Referral to HF clinic, Costs and Safety) will be assessed.
- Resource utilization and costs [ Time Frame: 3 and 12 months ]Regression methods will be used to assess the incremental costs associated with the routine use of CMR.
- HF Diagnosis Variability: [ Time Frame: 3 and 12 months ]A local independent blinded heart failure expert will also be asked to diagnose the HF etiology in a subset of 100 patients (~10%) in order to determine inter-observer variability in each of the CMR selective and standard arms.
- Echo/CMR variability: [ Time Frame: baseline ]An anonymized copy of each CMR and each available echo will be sent to a core lab. A second interpretation will occur at the core lab in 10% of cases in order to assess reproducibility and quality assurance of the results.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
The study population includes patients with either
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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
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): NCT01281384
| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada | |
| University of Alberta | |
| Edmonton, Alberta, Canada | |
| Canada, Nova Scotia | |
| Dalhousie University | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Hamilton Health Sciences Centre | |
| Hamilton, Ontario, Canada | |
| London Health Sciences Centre | |
| London, Ontario, Canada | |
| University of Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada | |
| University of Laval | |
| Quebec City, Quebec, Canada | |
| Université de Sherbrooke | |
| Sherbrooke, Quebec, Canada | |
| Finland | |
| Helsinki University Central Hospital, | |
| Helsinki, Finland | |
| University of Kuopio | |
| Kuopio, Finland | |
| University of Turku | |
| Turku, Finland | |
| Study Director: | Rob SB Beanlands, MD, FRCP C | Universityof Ottawa Heart Institute | |
| Principal Investigator: | Ian Paterson, MD | University of Alberta |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rob Beanlands, Rob S. Beanlands, MD, FRCPC, Chief of Cardiology, Ottawa Heart Institute Research Corporation |
| ClinicalTrials.gov Identifier: | NCT01281384 |
| Other Study ID Numbers: |
Project I-B CIF-99470 ( Other Grant/Funding Number: Canadian Institutes of Health Research ) |
| First Posted: | January 21, 2011 Key Record Dates |
| Last Update Posted: | November 21, 2019 |
| Last Verified: | November 2019 |
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cardiac magnetic resonance imaging echocardiography heart failure imaging |
cost effectiveness quality of life definitive diagnosis prospective comparative effectiveness randomized clinical trial |
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Heart Failure Heart Diseases Cardiovascular Diseases |