Heart FailureOUTSMARTNCT01281384
Routine vs Selective Cardiac Magnetic Resonance in Non-Ischemic Heart Failure
A study testing Advanced Imaging and Standard Imaging in people with Heart Failure, run by Ottawa Heart Institute Research Corporation at 14 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Advanced Imaging and Standard Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jan 2011to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Canada11 sites
University of Calgary
Calgary, Alberta
University of Alberta
Edmonton, Alberta
Dalhousie University
Halifax, Nova Scotia
Hamilton Health Sciences Centre
Hamilton, Ontario
London Health Sciences Centre
London, Ontario
Montreal Heart Institute
Montreal, Quebec
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
University of Laval
Québec, Quebec
Université de Sherbrooke
Sherbrooke, Quebec
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
Finland3 sites
Helsinki University Central Hospital,
Helsinki
University of Kuopio
Kuopio
University of Turku
Turku
About this study
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)
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- Advanced Imaging, Standard Imaging
- Keywords
- cardiac magnetic resonance imaging, echocardiography, heart failure, imaging, cost effectiveness, quality of life, definitive diagnosis, prospective comparative effectiveness randomized clinical trial
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced ImagingOther
Also called Cardiac Magnetic Resonance Imaging (CMR)
Standard ImagingOther
Also called Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Standard imaging (echocardiography) | Active comparator | Subjects will undergo their clinically indicated echocardiogram as ordered by their attending physician. Receives: Other: Standard Imaging |
| Advanced Imaging (Cardiac MRI) | Active comparator | 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. Receives: Other: Advanced Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of definitive diagnoses
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.
Measured: 3 and 12 months
Secondary outcomes (5)
Treatment effects
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.
Measured: 3 and 12 months
Clinical Endpoints
CCE (Death, Cardiovascular (CV) death, HF admission), left ventricular (LV) Function, QoL, Referral to HF clinic, Costs and Safety) will be assessed.
Measured: 3 and 12 months
Resource utilization and costs
Regression methods will be used to assess the incremental costs associated with the routine use of CMR.
Measured: 3 and 12 months
HF Diagnosis Variability:
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.
Measured: 3 and 12 months
Echo/CMR variability:
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Finnish Funding Agency for Technology and Innovation
- Responsible party
- Principal investigator, Rob Beanlands, Ottawa Heart Institute Research Corporation
- Investigators
- Rob SB Beanlands, MD, FRCP C, Study director, Universityof Ottawa Heart InstituteIan Paterson, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281384
- Sponsor's protocol ID
- Project I-B
- Other IDs
- CIF-99470
- Acronym
- OUTSMART
- Status last verified
- Nov 2019
- First submitted
- 20 Jan 2011
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paterson DI, OMeara E, Chow BJ, Ukkonen H, Beanlands RS. Recent advances in cardiac imaging for patients with heart failure. Curr Opin Cardiol. 2011 Mar;26(2):132-43. doi: 10.1097/HCO.0b013e32834380e7.
PubMed 21297464Paterson I, Wells GA, Ezekowitz JA, White JA, Friedrich MG, Mielniczuk LM, O'Meara E, Chow B, DeKemp RA, Klein R, Dennie C, Dick A, Coyle D, Dwivedi G, Rajda M, Wright GA, Laine M, Hanninen H, Larose E, Connelly KA, Leong-Poi H, Howarth AG, Davies RA, Duchesne L, Yla-Herttuala S, Saraste A, Farand P, Garrard L, Tardif JC, Arnold M, Knuuti J, Beanlands R, Chan KL. Routine versus selective cardiac magnetic resonance in non-ischemic heart failure - OUTSMART-HF: study protocol for a randomized controlled trial (IMAGE-HF (heart failure) project 1-B). Trials. 2013 Oct 12;14:332. doi: 10.1186/1745-6215-14-332.
PubMed 24119686Paterson DI, Wells G, Erthal F, Mielniczuk L, O'Meara E, White J, Connelly KA, Knuuti J, Radja M, Laine M, Chow BJW, Kandolin R, Chen L, Dick A, Dennie C, Garrard L, Ezekowitz J, Beanlands R, Chan KL; IMAGE-HF Investigators. OUTSMART HF: A Randomized Controlled Trial of Routine Versus Selective Cardiac Magnetic Resonance for Patients With Nonischemic Heart Failure (IMAGE-HF 1B). Circulation. 2020 Mar 10;141(10):818-827. doi: 10.1161/CIRCULATIONAHA.119.043964. Epub 2020 Jan 8.
PubMed 31910649
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01281384
- Acronym / sponsor ID
- OUTSMART / Project I-B
- Conditions
- Heart Failure
- Keywords
- cardiac magnetic resonance imaging, echocardiography, heart failure, imaging, cost effectiveness, quality of life, definitive diagnosis, prospective comparative effectiveness randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Finnish Funding Agency for Technology and Innovation
- Study start
- Jan 2011
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard imaging (echocardiography) | Active comparator | Other: Standard ImagingSubjects will undergo their clinically indicated echocardiogram as ordered by their attending physician. |
| Advanced Imaging (Cardiac MRI) | Active comparator | Other: Advanced ImagingSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced ImagingAlso: Cardiac Magnetic Resonance Imaging (CMR) | Other | Advanced Imaging (Cardiac MRI) |
| Standard ImagingAlso: Echocardiography | Other | Standard imaging (echocardiography) |
Primary outcome
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.
5 secondary outcomes
Treatment effects
Time frame: 3 and 12 months
Clinical Endpoints
Time frame: 3 and 12 months
Resource utilization and costs
Time frame: 3 and 12 months
HF Diagnosis Variability:
Time frame: 3 and 12 months
Echo/CMR variability:
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Background: PubMed 21297464Paterson DI, OMeara E, Chow BJ, Ukkonen H, Beanlands RS. Recent advances in cardiac imaging for patients with heart failure. Curr Opin Cardiol. 2011 Mar;26(2):132-43. doi: 10.1097/HCO.0b013e32834380e7.
- Background: PubMed 24119686Paterson I, Wells GA, Ezekowitz JA, White JA, Friedrich MG, Mielniczuk LM, O'Meara E, Chow B, DeKemp RA, Klein R, Dennie C, Dick A, Coyle D, Dwivedi G, Rajda M, Wright GA, Laine M, Hanninen H, Larose E, Connelly KA, Leong-Poi H, Howarth AG, Davies RA, Duchesne L, Yla-Herttuala S, Saraste A, Farand P, Garrard L, Tardif JC, Arnold M, Knuuti J, Beanlands R, Chan KL. Routine versus selective cardiac magnetic resonance in non-ischemic heart failure - OUTSMART-HF: study protocol for a randomized controlled trial (IMAGE-HF (heart failure) project 1-B). Trials. 2013 Oct 12;14:332. doi: 10.1186/1745-6215-14-332.
- Derived from this study: PubMed 31910649Paterson DI, Wells G, Erthal F, Mielniczuk L, O'Meara E, White J, Connelly KA, Knuuti J, Radja M, Laine M, Chow BJW, Kandolin R, Chen L, Dick A, Dennie C, Garrard L, Ezekowitz J, Beanlands R, Chan KL; IMAGE-HF Investigators. OUTSMART HF: A Randomized Controlled Trial of Routine Versus Selective Cardiac Magnetic Resonance for Patients With Nonischemic Heart Failure (IMAGE-HF 1B). Circulation. 2020 Mar 10;141(10):818-827. doi: 10.1161/CIRCULATIONAHA.119.043964. Epub 2020 Jan 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob SB Beanlands, MD, FRCP C study director
Universityof Ottawa Heart Institute
Ian Paterson, MD principal investigator
University of Alberta
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Imaging and Standard Imaging in people with Heart Failure, run by Ottawa Heart Institute Research Corporation at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of definitive diagnoses (time frame: 3 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01281384, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.