Routine vs Selective Cardiac Magnetic Resonance in Non-Ischemic Heart Failure

NCT ID: NCT01281384

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 518 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2018-12-31

Brief 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 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard imaging (echocardiography)

Subjects will undergo their clinically indicated echocardiogram as ordered by their attending physician.

Group Type: ACTIVE_COMPARATOR

Standard Imaging

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Advanced Imaging

Intervention Type: OTHER

Interventions

Advanced Imaging

Intervention Type: OTHER

Standard Imaging

Intervention Type: OTHER

Other Intervention Names

Cardiac Magnetic Resonance Imaging (CMR); Echocardiography

Eligibility Criteria

Inclusion Criteria

1. Age > 18

2. 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%)

3. Documented history of Class II-IV NYHA HF symptoms within the past 12 months

Exclusion Criteria

1. Prior CMR and no major change in clinical condition

2. Well-documented specific etiology (eg known amyloidosis or hemochromatosis)

3. MD considers cause of heart failure is attributable to obstructive CAD.

4. Documented previous STEMI (any territory) or NSTEMI in LAD territory

5. Severe medical conditions that significantly affect the patient's outcome (eg. active malignancy)

6. Ongoing need for advanced cardiac life support (eg IABP)

7. Severe valvular heart disease requiring surgery within the next 6 months

8. Contraindications to CMR (e.g. certain metallic implants, severe claustrophobia)

9. Contraindications to gadolinium contrast agent (GFR < 30ml/min/1,72m2, pregnancy)

10. Inability to give informed consent

11. Evidence of multivessel ischemia on stress imaging

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

The Finnish Funding Agency for Technology and Innovation (TEKES)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Rob Beanlands

Rob S. Beanlands, MD, FRCPC, Chief of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rob SB Beanlands, MD, FRCP C

Role: STUDY_DIRECTOR

Universityof Ottawa Heart Institute

Ian Paterson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Dalhousie University

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

University of Laval

Québec, Quebec, Canada

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Helsinki University Central Hospital,

Helsinki, , Finland

University of Kuopio

Kuopio, , Finland

University of Turku

Turku, , Finland

Countries

Canada; Finland

References

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.

Reference Type: BACKGROUND

PMID: 21297464 (View on PubMed)

Paterson 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.

Reference Type: BACKGROUND

PMID: 24119686 (View on PubMed)

Paterson 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.

Reference Type: DERIVED

PMID: 31910649 (View on PubMed)

Other Identifiers

CIF-99470

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Project I-B

Identifier Type: -

Identifier Source: org_study_id