American Heart Journal
Volume 151, Issue 2 , Pages 288-294 , February 2006

Rationale and design of a randomized controlled trial to assess the safety and efficacy of cardiac resynchronization therapy in patients with asymptomatic left ventricular dysfunction with previous symptoms or mild heart failure—the REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) study

  • Cecilia Linde, MD, PhD

      Affiliations

    • Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
    • Corresponding Author InformationReprint requests: Cecilia Linde, MD, PhD, Department of Cardiology, Karolinska University Hospital, S-17176 Stockholm, Sweden.
    • ,
  • Michael Gold, MD

      Affiliations

    • Division of Cardiology, Medical University of South Carolina, Charleston, SC
    • ,
  • William T. Abraham, MD

      Affiliations

    • Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, The Ohio State University, Columbus, Ohio
    • ,
  • Jean-Claude Daubert, MD

      Affiliations

    • Département de Cardiologie, CHU, Rennes, France
    • ,
  • for the REVERSE Study Group

Received 18 November 2004 ,Accepted 1 March 2005.

References 

  1. Cazeau S, Leclercq C, Lavergne T, et al. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001;344:873–880
  2. Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002;346:1845–1853
  3. Linde C, Leclercq C, Rex S, et al. Long-term benefits of biventricular pacing in congestive heart failure: results from the MUltisite STimulation In Cardiomyopathy (MUSTIC) study. J Am Coll Cardiol. 2002;40:111–118
  4. St John Sutton MG, Plappert T, Abraham WT, et al. Effect of cardiac resynchronization therapy on left ventricular size and function in chronic heart failure. Circulation. 2003;107:1985–1990
  5. Abraham WT, Young JB, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. Circulation. 2004;110:2864–2868
  6. Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: executive summary. J Heart Lung Transplant. 2002;21:189–203
  7. Packer M. Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure. J Card Fail. 2001;7:176–182
  8. Remme WJ, Swedberg K. Guidelines for the diagnosis and treatment of chronic heart failure. Eur Heart J. 2001;22:1527–1560
  9. Felker GM, Shaw LK, O'Connor CM. A standardized definition of ischemic cardiomyopathy for use in clinical research. J Am Coll Cardiol. 2002;39:210–218
  10. Gregoratos E, Abrams J, Epstein AE, et al. ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2002;40:1703–1719
  11. Connolly SJ, Talajic M, Cairns JA, et al. Prevention of sudden death from ventricular arrhythmia. Canadian cardiovascular society 1999 consensus conference. Can J Cardiol. 2000;16(Suppl C):1C–94C
  12. Priori SG, Aliot E, Blomstrom-Lundqvist C, et al. Update of the guidelines on sudden cardiac death of the European Society of Cardiology. Eur Heart J. 2003;24:13–15
  13. Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877–883
  14. Buxton AE, Lee KL, Fisher JD, et al. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999;341:1882–1890
  15. Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225–237
  16. Cleland JGF, Daubert JC, Erdmann E, et al. for the CARE-HF Steering Committee and Investigators The CARE-HF study (Cardiac Resynchronisation in Heart Failure study) rationale, design and end-points. Eur Heart Fail. 2001;3:481–489
  17. Konstam MA, Udelson JE, Anand IS, et al. Ventricular remodeling in heart failure: a credible surrogate endpoint. J Card Fail. 2003;9:350–353
  18. Carson P, Tognoni G, Cohn JN. Effect of valsartan on hospitalization: results from the Val-HeFT. J Card Fail. 2003;9:164–171
  19. Wong M, Staszewsky L, Latini R, et al. Severity of left ventricular remodelling defines outcomes and response to therapy in heart failure: Valsartan Heart Failure Trial (Val-HeFT) echocardiographic data. J Am Coll Cardiol. 2004;43:2022–2027
  20. White HD, Norris RM, Brown MA, et al. Left ventricular end-systolic volume as the major determinant of survival after recovery from myocardial infarction. Circulation. 1987;76:44–51
  21. Duncan A, Wait D, Gibson D, et al. Left ventricular remodeling and hemodynamic effects of multisite biventricular pacing in patients with left ventricular systolic dysfunction and activation disturbances in sinus rhythm: sub-study of the MUSTIC (Multisite Stimulation In Cardiomyopathies) trial. Eur Heart J. 2003;24:430–441
  22. Yu CM, Chau E, Sanderson JE, et al. Tissue Doppler echocardiographic evidence of reverse remodeling and improved synchronicity by simultaneously delaying regional contraction after biventricular pacing therapy in heart failure. Circulation. 2002;105:438–445
  23. Green CP, Porter CB, Bresnahan DR, et al. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000;35:1245–1255
  24. Heart disease and stroke statistics—2004 update. Dallas (Tex): American Heart Association; 2003;
  25. Mosterd A, Hoes AW, de Bruyne MC, et al. Prevalence of heart failure and left ventricular dysfunction in the general population; The Rotterdam Study. Eur Heart J. 1999;20:447–455
  26. McDonagh TA, Robb SD, Murdoch DR, et al. Biochemical detection of left-ventricular systolic dysfunction. Lancet. 1998;351:9–13
  27. The SOLVD Investigators . Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. N Engl J Med. 1992;327:685–691
  28. Wang TJ, Evans JC, Benjamin EJ, et al. Natural history of asymptomatic left ventricular systolic dysfunction in the community. Circulation. 2003;108:977–982
  29. Levy D, Kenchaiah S, Larson MG, et al. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002;347:1397–1402
  30. Silvet H, Amit J, Padmanabhan S. Increased QRS-duration reduces survival in patients with left ventricular dysfunction: results form a cohort of 2263 patients. [abstract] J Am Coll Cardiol. 1999;33:145A
  31. Baldasseroni S, Opasich C, Gorini M, et al. Left bundle-branch block is associated with increased 1-year sudden and total mortality rate in 5517 outpatients with congestive heart failure: a report from the Italian network on congestive heart failure. Am Heart J. 2002;143:398–405
  32. McMurray J, McDonagh T, Morrison CE, et al. Trends in hospitalization for heart failure in Scotland 1980-1990. Eur Heart J. 1993;14:1158–1162
  33. Berry C, Murdoch DR, McMurray JJ. Economics of chronic heart failure. Eur J Heart Fail. 2001;3:283–291
  34. Cohn JN, Ferrari R, Sharpe N. Cardiac remodeling-concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling. Behalf of an international forum on cardiac remodeling. J Am Coll Cardiol. 2000;35:569–582
  35. Bristow MR, Gilbert EM, Abraham WT, et al. Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure. MOCHA Investigators. Circulation. 1996;94:2807–2816
  36. Kawai K, Takaoka H, Hata K, et al. Prevalence, predictors, and prognosis of reversal of maladaptive remodeling with intensive medical therapy in idiopathic dilated cardiomyopathy. Am J Cardiol. 1999;84:671–676
  37. Higgins SL, Hummel JD, Niazi IK, et al. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J Am Coll Cardiol. 2003;42:1454–1459
  38. Bristow MR, Saxon LA, Boehmer J, et al. Cardiac resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350:2140–2150
  39. Braunschweig F, Gras D, Mortensen P, et al. Do heart failure patients in NYHA class II improve by cardiac resynchronisation therapy?. Heart Rhythm. 2004;1:S247

 Supported by Medtronic Bakken Research Center BV, Maastricht, NL, Europe, and Medtronic Inc, Minneapolis, Minn.

PII: S0002-8703(05)00222-X

doi: 10.1016/j.ahj.2005.03.002

American Heart Journal
Volume 151, Issue 2 , Pages 288-294 , February 2006

Article Tools

* Image Usage & Resolution