Current Heart Failure Reports

, Volume 10, Issue 4, pp 373–379 | Cite as

Similarities and Differences in Patient Characteristics Between Heart Failure Registries Versus Clinical Trials

  • Abhinav Sharma
  • Justin A. EzekowitzEmail author
Epidemiology of Heart Failure (J Butler, Section Editor)


Acute and chronic heart failure results in significant morbidity and mortality to patients and is a major concern for the healthcare systems. Various randomized controlled trials have demonstrated an improvement in morbidity and mortality for patients with heart failure. However, the findings of these trials are often applicable to a limited population. Several large-scale registries are now shedding insight as to the treatment, outcomes, and follow-up of patients in a real-life clinical setting. The objective of this review is to examine some of the heart failure therapies, such as cardiac resynchronization therapy, implantable cardioverter defibrillators and medications, in the context of randomized trials versus clinical registries. This review will also identify how registries are improving patient outcomes and how they are uncovering differences and gaps in treatment in non-randomized trial settings.


Clinical trials Epidemiology Registry Heart failure Pharmacologic therapy Implantable devices 


Compliance with Ethics Guidelines

Conflict of Interest

Abhinav Sharma declares that he has no conflict of interest.

Justin A. Ezekowitz is supported by grants from Johnson & Johnson (ASCEND Clinical Trial Steering Committee) and Amgen (ATOMIC Clinical Trial Steering Committee).

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.


Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. 1.
    McKelvie RS, Moe GW, Ezekowitz JA, Heckman GA, Costigan J, Ducharme A, et al. The 2012 Canadian Cardiovascular Society Heart Failure Management Guidelines Update: focus on acute and chronic heart failure. CJCA. 2013;29(2):168–81.Google Scholar
  2. 2.
    America HFSO. Executive summary: HFSA 2010 comprehensive heart failure practice guideline. J Card Fail. 2010;16(6):475–539.CrossRefGoogle Scholar
  3. 3.
    McMurray JJV, Adamopoulos S, Anker SD, Auricchio A, Bohm M, et al. 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;33(14):1787–847.PubMedCrossRefGoogle Scholar
  4. 4.
    Jessup M, Abraham WT, Casey DE, Feldman AM, Francis GS, et al. Focused update: ACCF/AHA guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation. 2009;119(14):1977–2016.PubMedCrossRefGoogle Scholar
  5. 5.
    Bala MM, Akl EA, Sun X, Bassler D, Mertz D, Mejza F, et al. Randomized trials published in higher vs. lower impact journals differ in design, conduct, and analysis. J Clin Epidemiol. 2013;66(3):286–95.PubMedCrossRefGoogle Scholar
  6. 6.
    Kulkarni AV, Busse JW, Shams I. Characteristics associated with citation rates of the medical literature. PLoS One. 2007;2:e403.PubMedCrossRefGoogle Scholar
  7. 7.
    Franciosa JA. The potential role of community-based registries to complement the limited applicability of clinical trial results to the community setting: heart failure as an example. Am J Manag Care. 2004;10(7 Pt 2):487–92.PubMedGoogle Scholar
  8. 8.
    Bourg CA, Phillips BB. Rosiglitazone, myocardial ischemic risk, and recent regulatory actions. Ann Pharmacother. 2012;46(2):282–9.PubMedCrossRefGoogle Scholar
  9. 9.
    Gastelurrutia P, Lupón J, de Antonio M, Urrutia A, Díez C, Coll R, et al. Statins in heart failure: the paradox between large randomized clinical trials and real life. JMCP. 2012;87(6):555–60.Google Scholar
  10. 10.
    Hong Y, LaBresh KA. Overview of the American Heart Association “Get With the Guidelines” programs: coronary heart disease, stroke, and heart failure. Crit Pathw Cardiol. 2006;5:179–86.PubMedCrossRefGoogle Scholar
  11. 11.
    Schwamm LH, Fonarow GC, Reeves MJ, Pan W, Frankel M, Smith EE, et al. Get with the guidelines: stroke is associated with sustained improvement in care for patients hospitalized with acute stroke or TIA. Circulation. 2009;119:107–15.PubMedCrossRefGoogle Scholar
  12. 12.
    LaBresh KA, Fonarow GC, Smith Jr SC, Bonow RO, Smaha LC, Tyler PA, et al. Improved treatment of hospitalized coronary artery disease patients with the Get With the Guidelines Program. Crit Pathw Cardiol. 2007;6:98–105.PubMedCrossRefGoogle Scholar
  13. 13.
    • Heidenreich PA, Hernandez AF, Yancy CW, Liang L, Peterson ED, Fonarow GC. Get with the guidelines program participation, process of care, and outcome for Medicare Patients Hospitalized With Heart Failure. Circ Cardiovasc Qual Outcomes. 2012;5(1):37–43. This reference highlights the feasibility of creating a large-scale registry that promotes adherence to clinical guidelines.PubMedCrossRefGoogle Scholar
  14. 14.
    Fonarow GC, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, et al. Improving evidence-based care for heart failure in outpatient cardiology practices: primary results of the registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF). Circulation. 2010;122(6):585–96.PubMedCrossRefGoogle Scholar
  15. 15.
    Maggioni AP, Dahlstrom U, Filippatos G, Chioncel O, Crespo Leiro M, Drozdz J, et al. EURObservational Research Programme: the Heart Failure Pilot Survey (ESC-HF Pilot). Eur J Heart Fail. 2010;12:1076–84.PubMedCrossRefGoogle Scholar
  16. 16.
    Cardinal H, Monfared AA, Dorais M, LeLorier J. A comparison between persistence to therapy in ALLHAT and in everyday clinical practice: a generalizability issue. Can J Cardiol. 2004;20(4):417–21.PubMedGoogle Scholar
  17. 17.
    Hordijk-Trion M, Lenzen M, Wijns W, et al. EHS-CR Investigators. Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results from the Euro Heart Survey on Coronary Revascularization. Eur Heart J. 2006;27(6):671–8.PubMedCrossRefGoogle Scholar
  18. 18.
    Badano LP, DiLenarda A, Bellotti P, Albanese MC, Sinagra G, Fioretti PM. Patients with chronic heart failure encountered in daily clinical practice are different from the “typical” patient enrolled in therapeutic trials. Ital Heart J. 2003;4(2):84–91.PubMedGoogle Scholar
  19. 19.
    Al-Khatib SM, Hellkamp A, Bardy GH, Hammill S, Hall WJ, Mark DB, et al. Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials. JAMA. 2013;309(1):55–62.PubMedCrossRefGoogle Scholar
  20. 20.
    Moss AJ, Zareba W, Hall WJ, et al. Multicenter Automatic Defibrillator Implantation Trial II Investigators (2002). Prophylactic implantation of a defibrillator in pa- tients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346(12):877–83.PubMedCrossRefGoogle Scholar
  21. 21.
    Bardy GH, Lee KL, Mark DB, et al. Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352(3):225–37.PubMedCrossRefGoogle Scholar
  22. 22.
    Al-Khatib SM, Mi X, Wilkoff BL, Qualls LG, Frazier-Mills C, Setoguchi S, et al. Follow-up of Patients With New Cardiovascular Implantable Electronic Devices: are experts' recommendations implemented in routine clinical practice? Circ Arrhythm Electrophysiol. 2013;6(1):108–16.PubMedCrossRefGoogle Scholar
  23. 23.
    Daubert JP, Sesselberg HW, Huang DT. Implantable cardioverter-defibrillators for primary prevention: how do the data pertain to the aged? Am J Geriatr Cardiol. 2006;15(2):88–92.PubMedCrossRefGoogle Scholar
  24. 24.
    • McClellan MB, Tunis SR. Medicare coverage of ICDs. N Engl J Med. 2005;352(3):222–4. This reference provides excellent insight into the economic implications of ICDs.PubMedCrossRefGoogle Scholar
  25. 25.
    Medical Advisory Secretariat. Implantable cardioverter defibrillators. Prophylactic use: an evidence-based analysis. Ontario Health Technology Assessment Series 2005;5(14).Google Scholar
  26. 26.
    Ezekowitz JA, Rowe BH, Dryden DM, Hooton N, Vandermeer B, Spooner C, et al. Systematic review: implantable cardioverter defibrillators for adults with left ventricular systolic dysfunction. Ann Intern Med. 2007;147(4):251–62.PubMedCrossRefGoogle Scholar
  27. 27.
    Al-Majed NS, McAlister FA, Bakal JA, Ezekowitz JA. Meta-analysis: cardiac resynchronization therapy for patients with less symptomatic heart failure. Ann Intern Med. 2011;154(6):401–12.PubMedCrossRefGoogle Scholar
  28. 28.
    • Boriani G, Diemberger I, Biffi M, Martignani C. Cost-effectiveness of cardiac resynchronisation therapy. Heart. 2012;98(24):1828–36. This reference provides a very comprehensive analysis of the cost effectiveness of CRT.Google Scholar
  29. 29.
    Fumagalli S, Valsecchi S, Boriani G, Gasparini M, Landolina M, Lunati M, et al. Comparison of the usefulness of cardiac resynchronization therapy in Three Age-Groups. AJC. 2011;107(10):1510–6.CrossRefGoogle Scholar
  30. 30.
    Curtis AB, Yancy CW, Albert NM, Stough WG, Gheorghiade M, Heywood JT, et al. Cardiac resynchronization therapy utilization for heart failure: findings from IMPROVE HF. Am Heart J. 2009;158(6):956–64.PubMedCrossRefGoogle Scholar
  31. 31.
    Shukla A, Curtis AB, Mehra MR, Albert NM, Gheorghiade M, Heywood JT, et al. Factors associated with improvement in utilization of cardiac resynchronization therapy in eligible heart failure patients: findings from IMPROVE HF. Pacing Clin Electrophysiol. 2013;36(4):433–43.PubMedCrossRefGoogle Scholar
  32. 32.
    Taubert G, Bergmeier C, Andresen H, Senges J, Potratz J. Clinical profile and management of heart failure: rural community hospital vs. metropolitan heart center. Eur J Heart Fail. 2001;3(5):611–7.PubMedCrossRefGoogle Scholar
  33. 33.
    Sanborn MD, Manuel DG, Ciechanska E, Lee DS. Potential gaps in congestive heart failure management in a rural hospital. Can J Rural Med. 2005;10(3):155–61.PubMedGoogle Scholar
  34. 34.
    Clark RA, Eckert KA, Stewart S, Phillips SM, Yallop JJ, Tonkin AM, et al. Rural and urban differentials in primary care management of chronic heart failure: new data from the CASE study. Med J Aust. 2007;186(9):441.PubMedGoogle Scholar
  35. 35.
    Muus KJ, Knudson A, Klug MG, Gokun J, Sarrazin M, Kaboli P. Effect of postdischarge follow-up care on re-admissions among US veterans with congestive heart failure: a rural–urban comparison. Rural Rem Health. 2010;10(2):1447.Google Scholar
  36. 36.
    Lenzen MJ. Under-utilization of evidence-based drug treatment in patients with heart failure is only partially explained by dissimilarity to patients enrolled in landmark trials: a report from the Euro Heart Survey on Heart Failure. Eur Heart J. 2005;26(24):2706–13.PubMedCrossRefGoogle Scholar
  37. 37.
    The SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med. 1991;325:293–302.CrossRefGoogle Scholar
  38. 38.
    The MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999;353:2001–7.CrossRefGoogle Scholar
  39. 39.
    Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, et al. The Randomized Aldactone Evaluation Study Investigators. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med. 1999;341:709–17.PubMedCrossRefGoogle Scholar
  40. 40.
    Sola S, Mir MQ, Lerakis S, Tandon N, Khan BV. Atorvastatin improves left ventricular systolic function and serum markers of inflammation in nonischemic heart failure. J Am Coll Cardiol. 2006;47(2):332–7.PubMedCrossRefGoogle Scholar
  41. 41.
    Node K, Fujita M, Kitakaze M, Hori M, Liao JK. Short-term statin therapy improves cardiac function and symptoms in patients with idiopathic dilated cardiomyopathy. Circulation. 2003;108(7):839–43.PubMedCrossRefGoogle Scholar
  42. 42.
    Mozaffarian D, Nye R, Levy WC. Statin therapy is associated with lower mortality among patients with severe heart failure. Am J Cardiol. 2004;93(9):1124–9.PubMedCrossRefGoogle Scholar
  43. 43.
    Krum H, Latini R, Maggioni AP, Anand I, Masson S, Carretta E, et al. Statins and symptomatic chronic systolic heart failure: a post-hoc analysis of 5010 patients enrolled in Val-HeFT. Int J Cardiol. 2007;119(1):48–53.PubMedCrossRefGoogle Scholar
  44. 44.
    Ramasubbu K, Estep J, White DL, et al. Experimental and clinical basis for the use of statins in patients with ischemic and nonischemic cardiomyopathy. J Am Coll Cardiol. 2008;51(4):415–26.PubMedCrossRefGoogle Scholar
  45. 45.
    Sumner AD, Boehmer JP, Saxon LA, Carson P, Feldman AM, Galle E, et al. Statin use is associated with improved survival in patients with advanced heart failure receiving resynchronization therapy. Congest Heart Fail. 2009;15(4):159–64.PubMedCrossRefGoogle Scholar
  46. 46.
    Kjekshus J, Apetrei E, Barrios V, Böhm M, Cleland JGF, Cornel JH, et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007;357(22):2248–61.PubMedCrossRefGoogle Scholar
  47. 47.
    GISSI-HF investigators. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. The Lancet. 2008;372(9645):1231–9.Google Scholar
  48. 48.
    Lavie CJ, Mehra MR. Statins and advanced heart failure-alive but barely breathing after CORONA and GISSI-HF. Congestive Heart Fail. 2009;15(4):157–8.CrossRefGoogle Scholar
  49. 49.
    •• Ezekowitz JA, Hu J, Delgado D, Hernandez AF, Kaul P, Leader R, et al. Acute heart failureclinical perspective perspectives from a randomized trial and a simultaneous registry. Circ Heart Fail. 2012;5(6):735–41. This excellent reference provides insight into the construction of a simultaneous RCT and registry.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  1. 1.University of AlbertaEdmontonCanada
  2. 2.Mazankowski Alberta Heart InstituteEdmontonCanada
  3. 3.Canadian VIGOUR CentreEdmontonCanada
  4. 4.EdmontonCanada

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