title: 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).
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT01281384.
authors.affiliation: Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, AB, Canada. ip3@ualberta.ca.
authors.forename: Ian
authors.initials: I
authors.lastname: Paterson
authors.forename: George A
authors.initials: GA
authors.lastname: Wells
authors.forename: Justin A
authors.initials: JA
authors.lastname: Ezekowitz
authors.forename: James A
authors.initials: JA
authors.lastname: White
authors.forename: Matthias G
authors.initials: MG
authors.lastname: Friedrich
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Mielniczuk
authors.forename: Eileen
authors.initials: E
authors.lastname: O'Meara
authors.forename: Benjamin
authors.initials: B
authors.lastname: Chow
authors.forename: Rob A
authors.initials: RA
authors.lastname: DeKemp
authors.forename: Ran
authors.initials: R
authors.lastname: Klein
authors.forename: Carole
authors.initials: C
authors.lastname: Dennie
authors.forename: Alexander
authors.initials: A
authors.lastname: Dick
authors.forename: Doug
authors.initials: D
authors.lastname: Coyle
authors.forename: Girish
authors.initials: G
authors.lastname: Dwivedi
authors.forename: Miroslaw
authors.initials: M
authors.lastname: Rajda
authors.forename: Graham A
authors.initials: GA
authors.lastname: Wright
authors.forename: Mika
authors.initials: M
authors.lastname: Laine
authors.forename: Helena
authors.initials: H
authors.lastname: Hanninen
authors.forename: Eric
authors.initials: E
authors.lastname: Larose
authors.forename: Kim A
authors.initials: KA
authors.lastname: Connelly
authors.forename: Howard
authors.initials: H
authors.lastname: Leong-Poi
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Howarth
authors.forename: Ross A
authors.initials: RA
authors.lastname: Davies
authors.forename: Lloyd
authors.initials: L
authors.lastname: Duchesne
authors.forename: Seppo
authors.initials: S
authors.lastname: Yla-Herttuala
authors.forename: Antti
authors.initials: A
authors.lastname: Saraste
authors.forename: Paul
authors.initials: P
authors.lastname: Farand
authors.forename: Linda
authors.initials: L
authors.lastname: Garrard
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Tardif
authors.forename: Malcolm
authors.initials: M
authors.lastname: Arnold
authors.forename: Juhani
authors.initials: J
authors.lastname: Knuuti
authors.forename: Rob
authors.initials: R
authors.lastname: Beanlands
authors.forename: Kwan L
authors.initials: KL
authors.lastname: Chan
mesh_terms: D002170:Canada; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D015150:Echocardiography, Doppler; D005387:Finland; D017048:Health Care Costs; D006333:Heart Failure / Q000175:diagnosis* / Q000191:economics / Q000209:etiology / Q000503:physiopathology / Q000628:therapy; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000191:economics / Q000379:methods*; D011237:Predictive Value of Tests; D011379:Prognosis; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D062606:Tertiary Care Centers; D013997:Time Factors