Heart & Lung: The Journal of Acute and Critical Care
Volume 37, Issue 1 , Pages 28-35 , January 2008

Clinical exacerbations as a surrogate end point in heart failure research

  • Steven L. Sayers, PhD

      Affiliations

    • Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania
    • Department of Psychiatry of the University of Pennsylvania, Philadelphia, Pennsylvania
    • Corresponding Author InformationReprint requests: Steven L. Sayers, PhD, Philadelphia Veterans Affairs Medical Center, University and Woodland Avenues, Philadelphia, PA, 19104.
  • ,
  • Barbara Riegel, DNSc, RN, CS, FAAN

      Affiliations

    • School of Nursing of the University of Pennsylvania, Philadelphia, Pennsylvania
  • ,
  • Lee R. Goldberg, MD, MPH

      Affiliations

    • Division of Cardiology, Department of Internal Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania.
  • ,
  • James C. Coyne, PhD

      Affiliations

    • Department of Psychiatry of the University of Pennsylvania, Philadelphia, Pennsylvania
  • ,
  • Frederick F. Samaha, MD

      Affiliations

    • Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania
    • Division of Cardiology, Department of Internal Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania.

References 

  1. National Heart Lung and Blood Institute. (US Dept of Health and Human Services). Congestive Heart Failure in the United States: A New Epidemic. 1996;Bethesda, MD
  2. Anand IS, Florea VG, Fisher L. Surrogate end points in heart failure. J Am Coll Cardiol. 2002;39(9):1414–1421
  3. Zanolla L, Zardini P. Selection of endpoints for heart failure clinical trials. Eur J Heart Fail. 2003;5(6):717–723
  4. Lucas C, Johnson W, Hamilton MA, et al. Freedom from congestion predicts good survival despite previous class IV symptoms of heart failure. Am Heart J. 2000;140(6):840–847
  5. Torosoff M, Sullivan BP, Fein SA, et al. Determinants of long-term survival in patients with congestive heart failure: the independent prognostic value of physical signs and symptoms. J Card Fail. 2003;9(5):S81
  6. Kaye DM, Lambert GW, Lefkovits J, et al. Neurochemical evidence of cardiac sympathetic activation and increased central nervous system norepinephrine turnover in severe congestive heart failure. J Am Coll Cardiol. 1994;23(3):570–578
  7. Harding S, Sayers S, Dieke A, et al. Exacerbations of heart failure as an index of treatment outcome. (abstr.) Ann Behav Med. 2003;(Suppl):S141
  8. Charlson ME, Pompei P, Ales KL, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–383
  9. Schulz R, Beach SR, Ives DG, et al. Association between depression and mortality in older adults: the Cardiovascular Health Study. Arch Intern Med. 2000;160(12):1761–1768
  10. 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(5):1245–1255
  11. Guyatt GH, Sullivan MJ, Thompson PJ, et al. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. CMAJ. 1985;132(8):919–923
  12. Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37–46
  13. American Heart Association. Heart Disease and Stroke Statistics—2005 Update. 2005;Vol. 2005. Dallas, TX
  14. McCullough PA, Philbin EF, Spertus JA, et al. Confirmation of a heart failure epidemic: findings from the Resource Utilization Among Congestive Heart Failure (REACH) study. J Am Coll Cardiol. 2002;39(1):60–69
  15. Philbin EF, DiSalvo TG. Influence of race and gender on care process, resource use, and hospital-based outcomes in congestive heart failure. Am J Cardiol. 1998;82(1):76–81
  16. Alexander M, Grumbach K, Remy L, et al. Congestive heart failure hospitalizations and survival in California: patterns according to race/ethnicity. Am Heart J. 1999;137(5):919–927
  17. Exner DV, Dries DL, Domanski MJ, et al. Lesser response to angiotensin-converting-enzyme inhibitor therapy in black as compared with white patients with left ventricular dysfunction. N Engl J Med. 2001;344(18):1351–1357
  18. Gillum RF. The epidemiology of cardiovascular disease in black Americans. N Engl J Med. 1996;335(21):1597–1599
  19. Dries DL, Exner DV, Gersh BJ, et al. Racial differences in the outcome of left ventricular dysfunction. N Engl J Med. 1999;340(8):609–616
  20. Wong MD, Shapiro MF, Boscardin WJ, et al. Contribution of major diseases to disparities in mortality. N Engl J Med. 2002;347(20):1585–1592
  21. SAS. (SAS Institute Inc.). SASSTAT Software, Version 9.1. 2002;Cary, NC
  22. 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 (A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to revise the 1995 Guidelines for the Evaluation and Management of Heart Failure)). J Am Coll Cardiol. 2001;38(7):2101–2113
  23. Fleiss JL. Measuring nominal scale agreement among many raters. Psych Bull. 1971;76:378–382
  24. Spertus J, Peterson E, Conard MW, et al. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. 2005;150(4):707–715
  25. Wang CS, FitzGerald JM, Schulzer M, et al. Does this dyspneic patient in the emergency department have congestive heart failure?. JAMA. 2005;294(15):1944–1956

 This work was supported by grant 0265447U from the American Heart Association, a VISN 4 Competitive Pilot Project Fund grant from the Department of Veterans Affairs, and the Mental Illness Research, Education, and Clinical Center of VISN 4. The project was performed at the Philadelphia VA Medical Center and the University of Pennsylvania Health System.

PII: S0147-9563(07)00044-1

doi: 10.1016/j.hrtlng.2007.02.002

Heart & Lung: The Journal of Acute and Critical Care
Volume 37, Issue 1 , Pages 28-35 , January 2008