Advertisement






Click here for more guidelines.
CME Topic Collections Past Issues Search Current Issue Home
     

J Am Coll Cardiol, 2002; 39:1414-1421
© 2002 by the American College of Cardiology Foundation
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Anand, I. S.
Right arrow Articles by Fisher, L.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Anand, I. S.
Right arrow Articles by Fisher, L.

REVIEW ARTICLE

Surrogate end points in heart failure

Inder S. Anand, MD, FRCP, DPhil (Oxon), FACC*,*, Viorel G. Florea, MD, PhD, DSc* and Lloyd Fisher, PhD, FACC{dagger}

* University of Minnesota Medical School and Veterans Affairs Medical Center, Minneapolis, Minnesota, USA
{dagger} Department of Biostatistics, University of Washington, Seattle, Washington, USA

Manuscript received December 27, 2000; revised manuscript received January 31, 2002, accepted February 6, 2002.

* Reprint requests and correspondence: Professor Inder S. Anand, Director of Heart Failure Program, Veterans Affairs Medical Center, One Veterans Drive 111-C, Minneapolis, Minnesota 55417, USA.
anand001{at}tc.umn.edu

Because of the increasing number of pharmacologic strategies available for treatment of heart failure (HF), the time has come to reassess the adequacy of end points used to evaluate therapeutic efficacy. Interest in the use of surrogate end points in clinical studies is increasing. A surrogate end point is defined as a measurement that can substitute for a true end point for the purpose of comparing specific interventions or treatments in a clinical trial. A true end point is one that is of clinical importance to the patient (e.g., mortality or quality of life), whereas a surrogate end point is one biologically closer to the disease process (e.g., ejection fraction or left ventricular volume in HF). The prime motivation for the use of a surrogate end point concerns the possible reduction in sample size or trial duration. Such reductions have important cost implications and in some cases may influence trial feasibility. Another, perhaps more important, aspect of measuring surrogate end points is that they increase our understanding of the mechanism of action of drugs and thus may help physicians to take a more enlightened approach in managing their patients. In this article we have analyzed the possible potentials of the surrogate end points in clinical studies of patients with chronic HF. Other uses of possible surrogates are discussed, and the limitations in finding true surrogates are mentioned. At this time we conclude there is no well established surrogate in HF.

Abbreviations and Acronyms
  BEST
  Beta-blocker Evaluation of Survival Trial
  BNP
  brain natriuretic peptide
  CONSENSUS
  Cooperative North Scandinavian Enalapril Survival Study
  EF
  ejection fraction
  FDA
  Food and Drug Administration
  HF
  heart failure
  LV
  left ventricular/ventricle
  MOXCON
  Effect of Sustained Release Moxonidine on Mortality and Morbidity in Patients with Congestive Heart Failure
  NE
  norepinephrine
  NYHA
  New York Heart Association
  Peak VO2
  maximal oxygen intake
  PRIME II
  Second Prospective Randomized Study of Ibopamine on Mortality and Efficacy
  PROMISE
  Prospective Randomized Milrinone Survival Evaluation trial
  QOL
  quality of life
  REFLECT
  Randomized Evaluation of FLosequinan on ExerCise Tolerance
  SAVE
  Survival And Ventricular Enlargement trial
  Val-HeFT
  Valsartan Heart Failure Trial
  V-HeFT
  Vasodilator-Heart Failure Trial




This article has been cited by other articles:


Home page
EuropaceHome page
P. W.X. Foley, F. Leyva, and M. P. Frenneaux
What is treatment success in cardiac resynchronization therapy?
Europace, November 1, 2009; 11(suppl_5): v58 - v65.
[Abstract] [Full Text] [PDF]


Home page
CirculationHome page
S. Goldman, M. McCarren, E. Morkin, P. W. Ladenson, R. Edson, S. Warren, J. Ohm, H. Thai, L. Churby, J. Barnhill, et al.
DITPA (3,5-Diiodothyropropionic Acid), a Thyroid Hormone Analog to Treat Heart Failure: Phase II Trial Veterans Affairs Cooperative Study
Circulation, June 23, 2009; 119(24): 3093 - 3100.
[Abstract] [Full Text] [PDF]


Home page
J Am Coll CardiolHome page
N. M. Hawkins, M. C. Petrie, M. I. Burgess, and J. J.V. McMurray
Selecting patients for cardiac resynchronization therapy: the fallacy of echocardiographic dyssynchrony.
J. Am. Coll. Cardiol., May 26, 2009; 53(21): 1944 - 1959.
[Abstract] [Full Text] [PDF]


Home page
ANN INTERN MEDHome page
J. A. Spertus, P. G. Jones, F. A. Masoudi, J. S. Rumsfeld, and H. M. Krumholz
Factors Associated With Racial Differences in Myocardial Infarction Outcomes
Ann Intern Med, March 3, 2009; 150(5): 314 - 324.
[Abstract] [Full Text] [PDF]


Home page
J Am Coll CardiolHome page
C. Ypenburg, R. J. van Bommel, C. J. W. Borleffs, G. B. Bleeker, E. Boersma, M. J. Schalij, and J. J. Bax
Long-term prognosis after cardiac resynchronization therapy is related to the extent of left ventricular reverse remodeling at midterm follow-up.
J. Am. Coll. Cardiol., February 10, 2009; 53(6): 483 - 490.
[Abstract] [Full Text] [PDF]


Home page
CirculationHome page
J. A. Spertus
Evolving Applications for Patient-Centered Health Status Measures
Circulation, November 11, 2008; 118(20): 2103 - 2110.
[Abstract] [Full Text] [PDF]


Home page
The Annals of PharmacotherapyHome page
S. de Denus, M. Zakrzewski-Jakubiak, M.-P. Dube, F. Belanger, S. Lepage, M.-H. Leblanc, D. Gossard, A. Ducharme, N. Racine, L. Whittom, et al.
Effects of AGTR1 A1166C Gene Polymorphism in Patients with Heart Failure Treated with Candesartan
Ann. Pharmacother., July 1, 2008; 42(7): 925 - 932.
[Abstract] [Full Text] [PDF]


Home page
EuropaceHome page
M. Stockburger, S. Fateh-Moghadam, A. Nitardy, O. Celebi, A. Krebs, D. Habedank, and R. Dietz
Baseline Doppler parameters are useful predictors of chronic left ventricular reduction in size by cardiac resynchronization therapy
Europace, January 1, 2008; 10(1): 69 - 74.
[Abstract] [Full Text] [PDF]


Home page
JAMAHome page
R. E. Shaddy, M. M. Boucek, D. T. Hsu, R. J. Boucek, C. E. Canter, L. Mahony, R. D. Ross, E. Pahl, E. D. Blume, D. A. Dodd, et al.
Carvedilol for Children and Adolescents With Heart Failure: A Randomized Controlled Trial
JAMA, September 12, 2007; 298(10): 1171 - 1179.
[Abstract] [Full Text] [PDF]


Home page
HypertensionHome page
R. L. Schultz, J. G. Swallow, R. P. Waters, J. A. Kuzman, R. A. Redetzke, S. Said, G. M. de Escobar, and A. M. Gerdes
Effects of Excessive Long-Term Exercise on Cardiac Function and Myocyte Remodeling in Hypertensive Heart Failure Rats
Hypertension, August 1, 2007; 50(2): 410 - 416.
[Abstract] [Full Text] [PDF]


Home page
CirculationHome page
R. Arena, J. Myers, M. A. Williams, M. Gulati, P. Kligfield, G. J. Balady, E. Collins, and G. Fletcher
Assessment of Functional Capacity in Clinical and Research Settings: A Scientific Statement From the American Heart Association Committee on Exercise, Rehabilitation, and Prevention of the Council on Clinical Cardiology and the Council on Cardiovascular Nursing
Circulation, July 17, 2007; 116(3): 329 - 343.
[Full Text] [PDF]


Home page
EuropaceHome page
E. de Teresa, J. J. Gomez-Doblas, G. Lamas, J. Alzueta, I. Fernandez-Lozano, E. Cobo, X. Navarro, F. Navarro-Lopez, and M. Stockburger
Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: rationale and design of the PREVENT-HF study
Europace, June 1, 2007; 9(6): 442 - 446.
[Abstract] [Full Text] [PDF]


Home page
Clin. Chem.Home page
S. Masson, R. Latini, I. S. Anand, T. Vago, L. Angelici, S. Barlera, E. D. Missov, A. Clerico, G. Tognoni, J. N. Cohn, et al.
Direct Comparison of B-Type Natriuretic Peptide (BNP) and Amino-Terminal proBNP in a Large Population of Patients with Chronic and Symptomatic Heart Failure: The Valsartan Heart Failure (Val-HeFT) Data
Clin. Chem., August 1, 2006; 52(8): 1528 - 1538.
[Abstract] [Full Text] [PDF]


Home page
J Am Coll CardiolHome page
A. Hirashiki, H. Izawa, F. Somura, K. Obata, T. Kato, T. Nishizawa, A. Yamada, H. Asano, S. Ohshima, A. Noda, et al.
Prognostic Value of Pacing-Induced Mechanical Alternans in Patients With Mild-to-Moderate Idiopathic Dilated Cardiomyopathy in Sinus Rhythm
J. Am. Coll. Cardiol., April 4, 2006; 47(7): 1382 - 1389.
[Abstract] [Full Text] [PDF]


Home page
Eur J Heart FailHome page
S. Capomolla, M. Ceresa, G. Pinna, R. Maestri, M. T. La Rovere, O. Febo, A. Rossi, V. Paganini, A. Caporotondi, G. Guazzotti, et al.
Echo-Doppler and clinical evaluations to define hemodynamic profile in patients with chronic heart failure: accuracy and influence on therapeutic management
Eur J Heart Fail, June 1, 2005; 7(4): 624 - 630.
[Abstract] [Full Text] [PDF]


Home page
HeartHome page
Y Sato, T Kita, Y Takatsu, and T Kimura
Biochemical markers of myocyte injury in heart failure
Heart, October 1, 2004; 90(10): 1110 - 1113.
[Abstract] [Full Text] [PDF]


Home page
J Am Coll CardiolHome page
M. Wong, L. Staszewsky, R. Latini, S. Barlera, R. Glazer, N. Aknay, A. Hester, I. Anand, and J. N. Cohn
Severity of left ventricular remodeling defines outcomes and response to therapy in heart failure: Valsartan heart failure trial (Val-HeFT) echocardiographic data
J. Am. Coll. Cardiol., June 2, 2004; 43(11): 2022 - 2027.
[Abstract] [Full Text] [PDF]


Home page
JCOHome page
S. E. Lipshultz and S. D. Colan
Cardiovascular Trials in Long-Term Survivors of Childhood Cancer
J. Clin. Oncol., March 1, 2004; 22(5): 769 - 773.
[Full Text] [PDF]


Home page
Eur Heart JHome page
R. Latini, S. Masson, I. Anand, M. Salio, A. Hester, D. Judd, S. Barlera, A. P Maggioni, G. Tognoni, J. N Cohn, et al.
The comparative prognostic value of plasma neurohormones at baseline in patients with heart failure enrolled in Val-HeFT
Eur. Heart J., February 2, 2004; 25(4): 292 - 299.
[Abstract] [Full Text] [PDF]


Home page
J Am Coll CardiolHome page
A. Cittadini, J.o. Isgaard, M. G. Monti, C. Casaburi, A. Di Gianni, R. Serpico, G. Iaccarino, and L. Sacca
Growth hormone prolongs survival in experimental postinfarction heart failure
J. Am. Coll. Cardiol., June 18, 2003; 41(12): 2154 - 2163.
[Abstract] [Full Text] [PDF]


Home page
J Am Coll CardiolHome page
A. D'Aloia, P. Faggiano, G. Aurigemma, L. Bontempi, G. Ruggeri, M. Metra, S. Nodari, and L. Dei Cas
Serum levels of carbohydrate antigen 125 in patients with chronic heart failure: Relation to clinical severity, hemodynamic and Doppler echocardiographic abnormalities, and short-term prognosis
J. Am. Coll. Cardiol., May 21, 2003; 41(10): 1805 - 1811.
[Abstract] [Full Text] [PDF]


Home page
CirculationHome page
I. S. Anand, L. D. Fisher, Y.-T. Chiang, R. Latini, S. Masson, A. P. Maggioni, R. D. Glazer, G. Tognoni, J. N. Cohn, and for the Val-HeFT Investigators
Changes in Brain Natriuretic Peptide and Norepinephrine Over Time and Mortality and Morbidity in the Valsartan Heart Failure Trial (Val-HeFT)
Circulation, March 11, 2003; 107(9): 1278 - 1283.
[Abstract] [Full Text] [PDF]


Home page
J Am Coll CardiolHome page
A. Abbate, G. G. L. Biondi-Zoccai, R. Bussani, A. Dobrina, D. Camilot, F. Feroce, R. Rossiello, F. Baldi, F. Silvestri, L. M. Biasucci, et al.
Increased myocardial apoptosis in patients with unfavorable left ventricular remodeling and early symptomatic post-infarction heart failure
J. Am. Coll. Cardiol., March 5, 2003; 41(5): 753 - 760.
[Abstract] [Full Text] [PDF]


Home page
CirculationHome page
E. O. Weinberg, M. Shimpo, S. Hurwitz, S.-i. Tominaga, J.-L. Rouleau, and R. T. Lee
Identification of Serum Soluble ST2 Receptor as a Novel Heart Failure Biomarker
Circulation, February 11, 2003; 107(5): 721 - 726.
[Abstract] [Full Text] [PDF]


Home page
Eur Heart JHome page
K. Dickstein and S. Snapinn
How should we analyse hospitalizations in clinical trials?
Eur. Heart J., January 1, 2003; 24(1): 24 - 25.
[Full Text] [PDF]


Home page
Cardiovasc ResHome page
J. T Stark, D. J Schaeffer, and D. R Gross
Response to: endomyocardial nitric oxide synthase and the hemodynamic phenotypes of human dilated cardiomyopathy and of athlete's heart
Cardiovasc Res, August 1, 2002; 55(2): 225 - 228.
[Full Text] [PDF]



 
  CME Topic Collections Past Issues Search Current Issue Home

Advertisement