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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Ottawa Heart Institute
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by (Responsible Party):
Rob Beanlands, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01281384
First received: January 20, 2011
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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 Intervention
Heart Failure
Other: Advanced Imaging
Other: Standard Imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • Frequency of definitive diagnoses [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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) HFPSF and (b) dilated cardiomyopathy (DCM) diagnoses (i.e. fewer idiopathic DCM) than the selective CMR group.



Secondary Outcome Measures:
  • Treatment effects [ Time Frame: 3 months, 1, 2 and 3 years ] [ Designated as safety issue: No ]
    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 months, 1, 2 and 3 years ] [ Designated as safety issue: No ]
    CCE (Death, CV death, HF admission), LV Function, QoL, Referral to HF clinic, Costs and Safety) will be assessed.

  • Resource utilization and costs [ Time Frame: 3 months, 1,2 and 3 years ] [ Designated as safety issue: No ]
    Regression methods will be used to assess the incremental costs associated with the routine use of CMR.

  • HF Diagnosis Variability: [ Time Frame: 3 months, 1,2 and 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 504
Study Start Date: January 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard imaging (echocardiography)
Subjects will undergo their clinically indicated echocardiogram as ordered by their attending physician.
Other: Standard Imaging
Other Name: Echocardiography
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.
Other: Advanced Imaging
Other Name: Cardiac Magnetic Resonance Imaging (CMR)

Detailed Description:

Primary objective: Compare the diagnostic yield of routine cardiac magnetic resonance versus standard care (i.e. echocardiography with only selective use of CMR) in patients with non-ischemic heart failure. The diagnostic categories of HF to be considered in this study include: idiopathic dilated cardiomyopathy, infiltrative cardiomyopathy, inflammatory cardiomyopathy, hypertrophic cardiomyopathy, heart failure with preserved ejection fraction (HFPEF), ischemic cardiomyopathy, mixed etiology and other (e.g. pericardial, congenital, non-compaction, right ventricular failure).

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.

Hypotheses:

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 non-specific diagnoses of idiopathic dilated cardiomyopathy and HFPEF.

Secondary hypotheses: Routine use of CMR will have a 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

Randomized controlled trial comparing i) routine CMR vs. ii) echocardiography with selective CMR in patient with HF due to a non-ischemic cardiomyopathy (NICM) and/or heart failure with preserved ejection fraction (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. (Figure 1).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients with new or worsening HF as above AND

  1. age > 18
  2. working clinical diagnosis (known or highly suspected) of non-ischemic cardiomyopathy (NICM) (ie. no significant obstructive CAD; no prior MI; negative non-invasive tests; and/or clinical scenario strongly suspicious for NICM) OR clinical diagnosis of HFPSF (Signs or symptoms of heart failure with a LVEF ≥ 40%)
  3. Class II-IV NYHA HF symptoms

Exclusion Criteria:

  1. Prior CMR and no major change in clinical condition
  2. well-documented specific etiology (eg known amyloidosis or hemochromatosis)
  3. documented obstructive CAD (at least one stenosis >50% in major epicardial vessels)
  4. documented previous MI
  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281384

Contacts
Contact: Linda M Garrard, RN, BScN 613-761-4192 lgarrard@ottawaheart.ca
Contact: Cathy Kelly, RN 613-761-4809 ckelly@ottawaheart.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Contact: Andrew Howarth, MD    Tel: (403) 944-8806    ahowarth@ucalgary.ca   
Principal Investigator: Andrew Howarth, MD         
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Ian Paterson, MD         
Principal Investigator: Ian Paterson, MD         
Canada, Nova Scotia
Dalhousie University Recruiting
Halifax, Nova Scotia, Canada
Contact: Miroslaw Rajda, MD       Miroslaw.Rajda@cdha.nshealth.ca   
Principal Investigator: Miroslaw Rajda, MD         
Sub-Investigator: James Clarke, MD         
Canada, Ontario
Hamilton Health Sciences Centre Recruiting
Hamilton, Ontario, Canada
Contact: Karen Gulenchyn, MD         
Principal Investigator: Karen Gulenchyn, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Malcolm Arnold, MD         
Principal Investigator: Malcolm Arnold, MD         
Sub-Investigator: Gerald Wisenberg, MD         
Sub-Investigator: James White, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Linda M Garrard, RN, BScN    613-761-4192    lgarrard@ottawaheart.ca   
Contact: Cathy Kelly, RN    613-761-4809    ckelly@ottawaheart.ca   
Sub-Investigator: Rob S. Beanlands, MD, FRCP C         
Principal Investigator: Lisa Mielniczuk, MD, FRCP C         
Sub-Investigator: George A Wells, PhD         
Sub-Investigator: Robert A. deKemp, PhD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Contact: Kim Connelly, MD    14168645201    connellyk@smh.ca   
Principal Investigator: Kim Connelly, MD         
Sub-Investigator: Michael Freeman, MD         
Sub-Investigator: Howard Leong-Poi, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Contact: Graham Wright, MD    (416)480-6869    gawright@sri.utoronto.ca   
Principal Investigator: Graham Wright, MD         
Principal Investigator: Kim Connelly, MD         
Sub-Investigator: Charles Cunningham Cunningham, MD         
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada
Contact: Eileen O'Meara, MD         
Principal Investigator: Eileen O'Meara, MD         
Sub-Investigator: Jean-Claude Tardif, MD         
University of Laval Recruiting
Quebec City, Quebec, Canada
Contact: Philippe Pibarot, MD         
Principal Investigator: Philippe Pibarot, MD         
Université de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada
Contact: Eric Turcotte, MD         
Principal Investigator: Eric Turcotte, MD         
Sub-Investigator: Serge Lepage, MD         
Sub-Investigator: Paul Pharand, MD         
Finland
Helsinki University Central Hospital, Recruiting
Helsinki, Finland
Contact: Mika Laine, MD    358 405 245735    Mika.Laine@hus.fi   
Principal Investigator: Mika Laine, MD         
University of Kuopio Recruiting
Kuopio, Finland
Contact: Juha Hartikainen, MD    044-711 3945    Juha.Hartikainen@kuh.fi   
Principal Investigator: Juha Hartikainen, MD         
Sub-Investigator: Satu Karkkainen, M D         
University of Turku Recruiting
Turku, Finland
Contact: Juhani Knuuti, MD         
Principal Investigator: Juhani Knuuti, MD         
Sub-Investigator: Heikki Ukkonen, MD         
Sponsors and Collaborators
University of Ottawa Heart Institute
Canadian Institutes of Health Research (CIHR)
The Finnish Funding Agency for Technology and Innovation (TEKES)
Investigators
Study Director: Rob SB Beanlands, MD, FRCP C Universityof Ottawa Heart Institute
Principal Investigator: Ian Paterson, MD University of Alberta
  More Information

No publications provided by University of Ottawa Heart Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rob Beanlands, Rob S. Beanlands, MD, FRCPC, Chief of Cardiology, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01281384     History of Changes
Other Study ID Numbers: Project I-B, CIF-99470
Study First Received: January 20, 2011
Last Updated: October 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa Heart Institute:
cardiac magnetic resonance imaging
echocardiography
heart failure
imaging
cost effectiveness
quality of life
definitive diagnosis

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014