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

NCT01281384 | Completed DMC

• 2 other identifiers: Project I-BCIF-99470
• Study Type: interventional
• Target: 518
• Locations: 2 countries
• Sites: 14

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 and 12 months

Secondary Outcomes (5)

• Treatment effects

  3 and 12 months

• Clinical Endpoints

  3 and 12 months

• Resource utilization and costs

  3 and 12 months

• HF Diagnosis Variability:

  3 and 12 months

• Echo/CMR variability:

  baseline

Study Arms (2)

Standard imaging (echocardiography)

ACTIVE COMPARATOR

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

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.

Other: Advanced Imaging

Interventions

Advanced Imaging OTHER

Also known as: Cardiac Magnetic Resonance Imaging (CMR)

Advanced Imaging (Cardiac MRI)

Standard Imaging OTHER

Also known as: Echocardiography

Standard imaging (echocardiography)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Finnish Funding Agency for Technology and Innovation (TEKES): collaborator

Study Sites (14)

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Dalhousie University

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

University of Laval

Québec, Quebec, Canada

Location

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Helsinki University Central Hospital,

Helsinki, Finland

Location

University of Kuopio

Kuopio, Finland

Location

University of Turku

Turku, Finland

Location

Related Publications (3)

• 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.

  PMID: 21297464 BACKGROUND

• 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.

  PMID: 24119686 BACKGROUND

• 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.

  PMID: 31910649 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rob SB Beanlands, MD, FRCP C

  Universityof Ottawa Heart Institute

  STUDY DIRECTOR

• Ian Paterson, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rob S. Beanlands, MD, FRCPC, Chief of Cardiology

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 21, 2011
• Study Start: January 1, 2011
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

FI (3); CA (11)