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 Paterson, George A Wells, Justin A Ezekowitz, James A White, Matthias G Friedrich, Lisa M Mielniczuk, Eileen O'Meara, Benjamin Chow, Rob A DeKemp, Ran Klein, Carole Dennie, Alexander Dick, Doug Coyle, Girish Dwivedi, Miroslaw Rajda, Graham A Wright, Mika Laine, Helena Hanninen, Eric Larose, Kim A Connelly, Howard Leong-Poi, Andrew G Howarth, Ross A Davies, Lloyd Duchesne, Seppo Yla-Herttuala, Antti Saraste, Paul Farand, Linda Garrard, Jean-Claude Tardif, Malcolm Arnold, Juhani Knuuti, Rob Beanlands, Kwan L Chan, Ian Paterson, George A Wells, Justin A Ezekowitz, James A White, Matthias G Friedrich, Lisa M Mielniczuk, Eileen O'Meara, Benjamin Chow, Rob A DeKemp, Ran Klein, Carole Dennie, Alexander Dick, Doug Coyle, Girish Dwivedi, Miroslaw Rajda, Graham A Wright, Mika Laine, Helena Hanninen, Eric Larose, Kim A Connelly, Howard Leong-Poi, Andrew G Howarth, Ross A Davies, Lloyd Duchesne, Seppo Yla-Herttuala, Antti Saraste, Paul Farand, Linda Garrard, Jean-Claude Tardif, Malcolm Arnold, Juhani Knuuti, Rob Beanlands, Kwan L Chan

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.

Figures

Figure 1
Figure 1
Flow diagram for OUTSMART-HF. Abbreviations: HF = heart failure and CMR = cardiac magnetic resonance.

References

    1. Shaw LJ, Narula J. Cardiovascular imaging quality-more than a pretty picture! JACC Cardiovasc Imaging. 2008;14:266–269. doi: 10.1016/j.jcmg.2008.01.005.
    1. Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC Jr. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA. 2009;14:831–841. doi: 10.1001/jama.2009.205.
    1. Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006;14:251–259. doi: 10.1056/NEJMoa052256.
    1. Tribouilloy C, Rusinaru D, Mahjoub H, Souliere V, Levy F, Peltier M, Slama M, Massy Z. Prognosis of heart failure with preserved ejection fraction: a five year prospective population-based study. Eur Heart J. 2008;14:339–347. doi: 10.1093/eurheartj/ehm554.
    1. Bhatia RS, Tu JV, Lee DS, Austin PC, Fang J, Haouzi A, Gong Y, Liu PP. Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med. 2006;14:260–269. doi: 10.1056/NEJMoa051530.
    1. Horwich TB, MacLellan WR, Fonarow GC. Statin therapy is associated with improved survival in ischemic and non-ischemic heart failure. J Am Coll Cardiol. 2004;14:642–648. doi: 10.1016/j.jacc.2003.07.049.
    1. Felker GM, Thompson RE, Hare JM, Hruban RH, Clemetson DE, Howard DL, Baughman KL, Kasper EK. Underlying causes and long-term survival in patients with initially unexplained cardiomyopathy. N Engl J Med. 2000;14:1077–1084. doi: 10.1056/NEJM200004133421502.
    1. Stein GY, Kremer A, Shochat T, Bental T, Korenfeld R, Abramson E, Ben-Gal T, Sagie A, Fuchs S. The diversity of heart failure in a hospitalized population: the role of age. J Card Fail. 2012;14:645–653. doi: 10.1016/j.cardfail.2012.05.007.
    1. Nagueh SF, Middleton KJ, Kopelen HA, Zoghbi WA, Quinones MA. Doppler tissue imaging: a noninvasive technique for evaluation of left ventricular relaxation and estimation of filling pressures. J Am Coll Cardiol. 1997;14:1527–1533. doi: 10.1016/S0735-1097(97)00344-6.
    1. Dokainish H, Sengupta R, Pillai M, Bobek J, Lakkis N. Assessment of left ventricular systolic function using echocardiography in patients with preserved ejection fraction and elevated diastolic pressures. Am J Cardiol. 2008;14:1766–1771. doi: 10.1016/j.amjcard.2008.02.070.
    1. Yip GW, Zhang Q, Xie JM, Liang YJ, Liu YM, Yan B, Lam YY, Yu CM. Resting global and regional left ventricular contractility in patients with heart failure and normal ejection fraction: insights from speckle-tracking echocardiography. Heart. 2011;14:287–294. doi: 10.1136/hrt.2010.205815.
    1. Bursi F, Weston SA, Redfield MM, Jacobsen SJ, Pakhomov S, Nkomo VT, Meverden RA, Roger VL. Systolic and diastolic heart failure in the community. JAMA. 2006;14:2209–2216. doi: 10.1001/jama.296.18.2209.
    1. Senni M, Rodeheffer RJ, Tribouilloy CM, Evans JM, Jacobsen SJ, Bailey KR, Redfield MM. Use of echocardiography in the management of congestive heart failure in the community. J Am Coll Cardiol. 1999;14:164–170. doi: 10.1016/S0735-1097(98)00523-3.
    1. Arnold JM, Liu P, Demers C, Dorian P, Giannetti N, Haddad H, Heckman GA, Howlett JG, Ignaszewski A, Johnstone DE, Jong P, McKelvie RS, Moe GW, Parker JD, Rao V, Ross HJ, Sequeira EJ, Svendsen AM, Teo K, Tsuyuki RT, White M. Canadian Cardiovascular Society consensus conference recommendations on heart failure 2006: diagnosis and management. Can J Cardiol. 2006;14:23–45. doi: 10.1016/S0828-282X(06)70237-9.
    1. Lindenfeld J, Albert NM, Boehmer JP, Collins SP, Ezekowitz JA, Givertz MM, Katz SD, Klapholz M, Moser DK, Rogers JG, Starling RC, Stevenson WG, Tang WH, Teerlink JR, Walsh MN. HFSA 2010 comprehensive heart failure practice guideline. J Card Fail. 2010;14:e1–e194. doi: 10.1016/j.cardfail.2010.04.004.
    1. McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: the task force for the diagnosis and treatment of acute and chronic heart failure 2012 of the European society of cardiology. Developed in collaboration with the heart failure association (HFA) of the ESC. Eur Heart J. 2012;14:1787–1847.
    1. Kramer CM, Budoff MJ, Fayad ZA, Ferrari VA, Goldman C, Lesser JR, Martin ET, Rajagopalan S, Reilly JP, Rodgers GP, Wechsler L, Creager MA, Holmes DR Jr, Merli G, Newby LK, Pina I, Rodgers GP, Weitz HH. ACCF/AHA 2007 clinical competence statement on vascular imaging with computed tomography and magnetic resonance. A report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training. J Am Coll Cardiol. 2007;14:1097–1114. doi: 10.1016/j.jacc.2007.07.006.
    1. Strohm O, Schulz-Menger J, Pilz B, Osterziel KJ, Dietz R, Friedrich MG. Measurement of left ventricular dimensions and function in patients with dilated cardiomyopathy. J Magn Reson Imaging. 2001;14:367–371. doi: 10.1002/jmri.1052.
    1. McCrohon JA, Moon JC, Prasad SK, McKenna WJ, Lorenz CH, Coats AJ, Pennell DJ. Differentiation of heart failure related to dilated cardiomyopathy and coronary artery disease using gadolinium-enhanced cardiovascular magnetic resonance. Circulation. 2003;14:54–59. doi: 10.1161/01.CIR.0000078641.19365.4C.
    1. Friedrich MG, Abdel-Aty H, Taylor A, Schulz-Menger J, Messroghli D, Dietz R. The salvaged area at risk in reperfused acute myocardial infarction as visualized by cardiovascular magnetic resonance. J Am Coll Cardiol. 2008;14:1581–1587. doi: 10.1016/j.jacc.2008.01.019.
    1. Assomull RG, Shakespeare C, Kalra PR, Lloyd G, Gulati A, Strange J, Bradlow WM, Lyne J, Keegan J, Poole-Wilson P, Cowie MR, Pennell DJ, Prasad SK. Role of cardiovascular magnetic resonance as a gatekeeper to invasive coronary angiography in patients presenting with heart failure of unknown etiology. Circulation. 2011;14:1351–1360. doi: 10.1161/CIRCULATIONAHA.110.011346.
    1. Abdel-Aty H, Boye P, Zagrosek A, Wassmuth R, Kumar A, Messroghli D, Bock P, Dietz R, Friedrich MG, Schulz-Menger J. Diagnostic performance of cardiovascular magnetic resonance in patients with suspected acute myocarditis: comparison of different approaches. J Am Coll Cardiol. 2005;14:1815–1822. doi: 10.1016/j.jacc.2004.11.069.
    1. Mahrholdt H, Goedecke C, Wagner A, Meinhardt G, Athanasiadis A, Vogelsberg H, Fritz P, Klingel K, Kandolf R, Sechtem U. Cardiovascular magnetic resonance assessment of human myocarditis: a comparison to histology and molecular pathology. Circulation. 2004;14:1250–1258. doi: 10.1161/01.CIR.0000118493.13323.81.
    1. Friedrich MG, Sechtem U, Schulz-Menger J, Holmvang G, Alakija P, Cooper LT, White JA, Abdel-Aty H, Gutberlet M, Prasad S, Aletras A, Laissy JP, Paterson I, Filipchuk NG, Kumar A, Pauschinger M, Liu P. Cardiovascular magnetic resonance in myocarditis: a JACC White Paper. J Am Coll Cardiol. 2009;14:1475–1487. doi: 10.1016/j.jacc.2009.02.007.
    1. Smedema JP, Snoep G, van Kroonenburgh MP, van Geuns RJ, Dassen WR, Gorgels AP, Crijns HJ. Evaluation of the accuracy of gadolinium-enhanced cardiovascular magnetic resonance in the diagnosis of cardiac sarcoidosis. J Am Coll Cardiol. 2005;14:1683–1690. doi: 10.1016/j.jacc.2005.01.047.
    1. Choudhury L, Mahrholdt H, Wagner A, Choi KM, Elliott MD, Klocke FJ, Bonow RO, Judd RM, Kim RJ. Myocardial scarring in asymptomatic or mildly symptomatic patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 2002;14:2156–2164. doi: 10.1016/S0735-1097(02)02602-5.
    1. Anderson LJ, Holden S, Davis B, Prescott E, Charrier CC, Bunce NH, Firmin DN, Wonke B, Porter J, Walker JM, Pennell DJ. Cardiovascular T2-star (T2*) magnetic resonance for the early diagnosis of myocardial iron overload. Eur Heart J. 2001;14:2171–2179. doi: 10.1053/euhj.2001.2822.
    1. Maceira AM, Joshi J, Prasad SK, Moon JC, Perugini E, Harding I, Sheppard MN, Poole-Wilson PA, Hawkins PN, Pennell DJ. Cardiovascular magnetic resonance in cardiac amyloidosis. Circulation. 2005;14:186–193. doi: 10.1161/01.CIR.0000152819.97857.9D.
    1. Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJ, Michelson EL, Olofsson B, Ostergren J. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial. Lancet. 2003;14:777–781. doi: 10.1016/S0140-6736(03)14285-7.
    1. Ahmed A, Rich MW, Fleg JL, Zile MR, Young JB, Kitzman DW, Love TE, Aronow WS, Adams KF Jr, Gheorghiade M. Effects of digoxin on morbidity and mortality in diastolic heart failure: the ancillary digitalis investigation group trial. Circulation. 2006;14:397–403. doi: 10.1161/CIRCULATIONAHA.106.628347.
    1. Cleland JG, Tendera M, Adamus J, Freemantle N, Polonski L, Taylor J. The perindopril in elderly people with chronic heart failure (PEP-CHF) study. Eur Heart J. 2006;14:2338–2345. doi: 10.1093/eurheartj/ehl250.
    1. Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De KG, Leite-Moreira AF, Borbely A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007;14:2539–2550. doi: 10.1093/eurheartj/ehm037.
    1. Iles L, Pfluger H, Phrommintikul A, Cherayath J, Aksit P, Gupta SN, Kaye DM, Taylor AJ. Evaluation of diffuse myocardial fibrosis in heart failure with cardiac magnetic resonance contrast-enhanced T1 mapping. J Am Coll Cardiol. 2008;14:1574–1580. doi: 10.1016/j.jacc.2008.06.049.
    1. Dass S, Suttie JJ, Piechnik SK, Ferreira VM, Holloway CJ, Banerjee R, Mahmod M, Cochlin L, Karamitsos TD, Robson MD, Watkins H, Neubauer S. Myocardial tissue characterization using magnetic resonance noncontrast t1 mapping in hypertrophic and dilated cardiomyopathy. Circ Cardiovasc Imaging. 2012;14:726–733. doi: 10.1161/CIRCIMAGING.112.976738.
    1. Hendel RC, Patel MR, Kramer CM, Poon M, Hendel RC, Carr JC, Gerstad NA, Gillam LD, Hodgson JM, Kim RJ, Kramer CM, Lesser JR, Martin ET, Messer JV, Redberg RF, Rubin GD, Rumsfeld JS, Taylor AJ, Weigold WG, Woodard PK, Brindis RG, Hendel RC, Douglas PS, Peterson ED, Wolk MJ, Allen JM, Patel MR. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. J Am Coll Cardiol. 2006;14:1475–1497. doi: 10.1016/j.jacc.2006.07.003.
    1. Arnold JM, Howlett JG, Dorian P, Ducharme A, Giannetti N, Haddad H, Heckman GA, Ignaszewski A, Isaac D, Jong P, Liu P, Mann E, McKelvie RS, Moe GW, Parker JD, Svendsen AM, Tsuyuki RT, O'Halloran K, Ross HJ, Rao V, Sequeira EJ, White M. Canadian Cardiovascular Society Consensus Conference recommendations on heart failure update 2007: prevention, management during intercurrent illness or acute decompensation, and use of biomarkers. Can J Cardiol. 2007;14:21–45. doi: 10.1016/S0828-282X(07)70211-8.
    1. Malcom J, Arnold O, Howlett JG, Ducharme A, Ezekowitz JA, Gardner MJ, Giannetti N, Haddad H, Heckman GA, Isaac D, Jong P, Liu P, Mann E, McKelvie RS, Moe GW, Svendsen AM, Tsuyuki RT, O'Halloran K, Ross HJ, Sequeira EJ, White M. Canadian Cardiovascular Society Consensus Conference guidelines on heart failure - 2008 update: best practices for the transition of care of heart failure patients, and the recognition, investigation and treatment of cardiomyopathies. Can J Cardiol. 2008;14:21–40. doi: 10.1016/S0828-282X(08)70545-2.
    1. Sanfilippo AJ, Bewick D, Chan KL, Cujec B, Dumesnil JG, Honos G, Munt B, Sasson Z, Tam J, Tomlinson C, Aboguddah A, Ahmed S, Ali M, Arsenault M, Ascah K, Ashton T, Baird M, Basmadjian A, Beique F, Blakeley M, Blais MJ, Burggraf G, Burwash I, Cochrane J, Fagan S, Giannoccaro P, Hughes W, Jones A, Jue J, Koilpillai C. et al.Guidelines for the provision of echocardiography in Canada: recommendations of a joint Canadian Cardiovascular Society/Canadian Society of Echocardiography Consensus Panel. Can J Cardiol. 2005;14:763–780.
    1. Chan KL, Teo K, Dumesnil JG, Ni A, Tam J. Effect of lipid lowering with rosuvastatin on progression of aortic stenosis: results of the aortic stenosis progression observation: measuring effects of rosuvastatin (ASTRONOMER) trial. Circulation. 2010;14:306–314. doi: 10.1161/CIRCULATIONAHA.109.900027.
    1. Gorcsan J III, Tanaka H. Echocardiographic assessment of myocardial strain. J Am Coll Cardiol. 2011;14:1401–1413. doi: 10.1016/j.jacc.2011.06.038.
    1. Hundley WG, Bluemke D, Bogaert JG, Friedrich MG, Higgins CB, Lawson MA, McConnell MV, Raman SV, van Rossum AC, Flamm S, Kramer CM, Nagel E, Neubauer S. Society for Cardiovascular Magnetic Resonance guidelines for reporting cardiovascular magnetic resonance examinations. J Cardiovasc Magn Reson. 2009;14:5. doi: 10.1186/1532-429X-11-5.
    1. Friedrich MG, Larose E, Patton D, Dick A, Merchant N, Paterson I. Canadian society for cardiovascular magnetic resonance (CanSCMR) recommendations for cardiovascular magnetic resonance image analysis and reporting. Can J Cardiol. 2013;14:260–265. doi: 10.1016/j.cjca.2012.07.007.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner