Open Access Study protocol

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)

Ian Paterson1*, George A Wells23, Justin A Ezekowitz1, James A White5, Matthias G Friedrich6, Lisa M Mielniczuk23, Eileen O’Meara6, Benjamin Chow234, Rob A deKemp23, Ran Klein23, Carole Dennie234, Alexander Dick234, Doug Coyle23, Girish Dwivedi2, Miroslaw Rajda7, Graham A Wright8, Mika Laine9, Helena Hanninen9, Eric Larose10, Kim A Connelly14, Howard Leong-Poi14, Andrew G Howarth11, Ross A Davies234, Lloyd Duchesne23, Seppo Yla-Herttuala15, Antti Saraste12, Paul Farand13, Linda Garrard23, Jean-Claude Tardif6, Malcolm Arnold5, Juhani Knuuti12131415, Rob Beanlands234 and Kwan L Chan234

Author Affiliations

1 Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, AB, Canada

2 Division of Cardiology, (including Cardiac Imaging, The National Cardiac PET Center, The Heart Failure Program, and the Cardiac Research Methods Center), Department of Medicine, University of Ottawa Heart Institute, Ottawa, ON, Canada

3 University of Ottawa, Ottawa, ON, Canada

4 Department of Radiology, The Ottawa Hospital, Ottawa, ON, Canada

5 London Health Sciences Center, London, ON, Canada

6 Montreal Heart Institute, Departments of Medicine and Radiology, Université de Montréal, Montreal, QC, Canada

7 Dalhousie University, Halifax, NS, Canada

8 Sunnybrook Health Sciences Center, Toronto, ON, Canada

9 Helsinki University Central Hospital, Helsinki, Finland

10 Université de Québec, Québec City, QC, Canada

11 University of Calgary, Calgary, AB, Canada

12 Turku PET Center, Turku, Finland

13 Université de Sherbrooke, Sherbrooke, QC, Canada

14 St. Michael’s Hospital, Toronto, ON, Canada

15 Heart Center, Kuopio University Hospital, Kuopio, Finland

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Trials 2013, 14:332  doi:10.1186/1745-6215-14-332

Published: 12 October 2013

Abstract

Background

Imaging has become a routine part of heart failure (HF) investigation. Echocardiography is a first-line test in HF given its availability and it provides valuable diagnostic and prognostic information. Cardiac magnetic resonance (CMR) is an emerging clinical tool in the management of patients with non-ischemic heart failure. Current ACC/AHA/CCS/ESC guidelines advocate its role in the detection of a variety of cardiomyopathies but there is a paucity of high quality evidence to support these recommendations.

The primary objective of this study is to compare the diagnostic yield of routine cardiac magnetic resonance versus standard care (that is, echocardiography with only selective use of CMR) in patients with non-ischemic heart failure. The primary hypothesisis that the routine use of CMR 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 HF with preserved ejection fraction.

Design

Tertiary care sites in Canada and Finland, with dedicated HF and CMR programs, will randomize consecutive patients with new or deteriorating HF to routine CMR or selective CMR. All patients will undergo a standard clinical echocardiogram and the interpreter will assign the most likely HF etiology. Those undergoing CMR will also have a standard examination and will be assigned a HF etiology based upon the findings. The treating physician’s impression about non-ischemic HF etiology will be collected following all baseline testing (including echo ± CMR). Patients will be followed annually for 4 years to ascertain clinical outcomes, quality of life and cost. The expected outcome is that the routine CMR arm will have a significantly higher rate of infiltrative, inflammatory, hypertrophic, ischemic and ‘other’ cardiomyopathy than the selective CMR group.

Discussion

This study will be the first multicenter randomized, controlled trial evaluating the role of CMR in non-ischemic HF. Non-ischemic HF patients will be randomized to routine CMR in order to determine whether there are any gains over management strategies employing selective CMR utilization. The insight gained from this study should improve appropriate CMR use in HF.

Trial registration

NCT01281384.

Keywords:
Heart failure; Echocardiography; Cardiac magnetic resonance; Randomized controlled trial