Overview of randomized clinical trials in acute heart failure syndromes

American Journal of Cardiology

Volumn 96, Issue 6 SUPPL., 2005, Pages 59-67

  Teerlink, John R ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b SAN FRANCISCO VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCIUM SENSITIZER; CONIVAPTAN; DIURETIC AGENT; DOBUTAMINE; ENDOTHELIN RECEPTOR ANTAGONIST; GLYCERYL TRINITRATE; INOTROPIC AGENT; LEVOSIMENDAN; MILRINONE; NESIRITIDE; NITROPRUSSIDE SODIUM; PLACEBO; POTASSIUM CHANNEL STIMULATING AGENT; TEZOSENTAN; TOLVAPTAN; VASODILATOR AGENT; VASOPRESSIN ANTAGONIST;

ACUTE HEART FAILURE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; DISEASE EXACERBATION; DIZZINESS; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HEART ATRIUM ARRHYTHMIA; HEART FUNCTION; HUMAN; HYPOTENSION; KIDNEY DISEASE; LUNG EDEMA; NAUSEA; PATIENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; SHORT COURSE THERAPY; SURVIVAL;

EID: 25144434821     PISSN: 00029149     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.amjcard.2005.07.022     Document Type: Article

References (55)

1. J.G. Cleland, K. Swedberg, F. Follath, M. Komajda, A. Cohen-Solal, J.C. Aguilar, R. Dietz, A. Gavazzi, R. Hobbs, J. Korewicki The EuroHeart Failure survey programme: a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis Eur Heart J 24 2003 442 463
2. J.R. Teerlink Dyspnea as an end point in clinical trials of therapies for acute decompensated heart failure Am Heart J 145 2003 S26 S33
3. Committee for Proprietary Medicinal Products (CPMP), Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Cardiac Failure: Addendum on Acute Cardiac Failure 2004 European Medicines Agency London Document No. CPMP/EWP/2986/03
4. M.S. Cuffe, R.M. Califf, K.F. Adams Jr, R. Benza, R. Bourge, W.S. Colucci, B.M. Massie, C.M. O'Connor, I. Pina, R. Quigg, M.A. Silver, M. Gheorghiade Short-term intravenous milrinone for acute exacerbation of chronic heart failure a randomized controlled trial JAMA 287 2002 1541 1547
5. F. Follath, J.G. Cleland, H. Just, J.G. Papp, H. Scholz, K. Peuhkurinen, V.P. Harjola, V. Mitrovic, M. Abdalla, E.P. Sandell, L. Lehtonen Efficacy and safety of intravenous levosimendan compared with dobutamine in severe low-output heart failure (the LIDO study) a randomised double-blind trial Lancet 360 2002 196 202
6. A.P. Coletta, J.G. Cleland, N. Freemantle, A.L. Clark Clinical trials update from the European Society of Cardiology Heart Failure meeting SHAPE, BRING-UP 2 VAS, COLA II, FOSIDIAL, BETACAR, CASINO and meta-analysis of cardiac resynchronisation therapy Eur J Heart Fail 6 2004 673 676
7. Publication Committee for the VMAC Investigators (Vasodilation in the Management of Acute CHF). Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure a randomized controlled trial JAMA 287 2002 1531 1540
8. M. Packer, W.S. Colucci, L. Fisher, B.M. Massie, J.R. Teerlink, J.B. Young, C.J. Garratt Development of a comprehensive new endpoint for the evaluation of new treatments for acute decompensated heart failure results with levosimendan in the REVIVE-1 study [abstract] J Card Fail 9 2003 S61
9. G. Torre-Amione, J.B. Young, W.S. Colucci, B.S. Lewis, C. Pratt, G. Cotter, K. Stangl, U. Elkayam, J.R. Teerlink, A. Frey, M. Rainisio, I. Kobrin Hemodynamic and clinical effects of tezosentan, an intravenous dual endothelin receptor antagonist, in patients hospitalized for acute decompensated heart failure J Am Coll Cardiol 42 2003 140 147
10. J.R. Teerlink, B.M. Massie, J.G.F. Cleland, D. Tzivoni for the RITZ-1 Investigators. A double-blind, parallel-group, multi-center, placebo-controlled study to investigate the efficacy and safety of tezosentan in reducing symptoms in patients with acute decompensated heart failure [abstract] Circulation 104 2001 II-526
11. G.M. Felker, R.L. Benza, A.B. Chandler, J.D. Leimberger, M.S. Cuffe, R.M. Califf, M. Gheorghiade, C.M. O'Connor Heart failure etiology and response to milrinone in decompensated heart failure results from the OPTIME-CHF study J Am Coll Cardiol 41 2003 997 1003
12. A.J. Burger, U. Elkayam, M.T. Neibaur, H. Haught, J. Ghali, D.P. Horton, D. Aronson Comparison of the occurrence of ventricular arrhythmias in patients with acutely decompensated congestive heart failure receiving dobutamine versus nesiritide therapy Am J Cardiol 88 2001 35 39
13. A.J. Burger, D. Aronson, D.P. Horton, M.R. Burger Comparison of the effects of dobutamine and nesiritide (B-type natriuretic peptide) on ventricular ectopy in acutely decompensated ischemic versus nonischemic cardiomyopathy Am J Cardiol 91 2003 1370 1372
14. F. Oliva, R. Latini, A. Politi, L. Staszewsky, A.P. Maggioni, E. Nicolis, F. Mauri Intermittent 6-month low-dose dobutamine infusion in severe heart failure DICE multicenter trial Am Heart J 138 1999 247 253
15. C.M. O'Connor, W.A. Gattis, B.F. Uretsky, K.F. Adams Jr, S.E. McNulty, S.H. Grossman, W.J. McKenna, F. Zannad, K. Swedberg, M. Gheorghiade, R.M. Califf Continuous intravenous dobutamine is associated with an increased risk of death in patients with advanced heart failure insights from the Flolan International Randomized Survival Trial (FIRST) Am Heart J 138 1999 78 86
16. M.A. Silver, D.P. Horton, J.K. Ghali, U. Elkayam Effect of nesiritide versus dobutamine on short-term outcomes in the treatment of patients with acutely decompensated heart failure J Am Coll Cardiol 39 2002 798 803
17. A. Mebazaa, A. Cohen-Solal, F.X. Kleber, M. Nieminen, M. Packer, S.J. Pocock, P. Poder, T. Sarapohja, M. Kivikko Study design of a mortality trial with intravenous levosimendan (the SURVIVE study) in patients with acutely decompensated heart failure [abstract] Crit Care 8 suppl 1 2004 P87
18. M. Komajda, F. Follath, K. Swedberg, J. Cleland, J.C. Aguilar, A. Cohen-Solal, R. Dietz, A. Gavazzi, W.H. Van Gilst, R. Hobbs The EuroHeart Failure Survey programme: a survey on the quality of care among patients with heart failure in Europe. Part 2: treatment Eur Heart J 24 2003 464 474
19. G. Cotter, E. Metzkor, E. Kaluski, Z. Faigenberg, R. Miller, A. Simovitz, O. Shaham, D. Marghitay, M. Koren, A. Blatt Randomised trial of high-dose isosorbide dinitrate plus low-dose furosemide versus high-dose furosemide plus low-dose isosorbide dinitrate in severe pulmonary oedema Lancet 351 1998 389 393
20. N.H. Guiha, J.N. Cohn, E. Mikulic, J.A. Franciosa, C.J. Limas Treatment of refractory heart failure with infusion of nitroprusside N Engl J Med 291 1974 587 592
21. U.N. Khot, G.M. Novaro, Z.B. Popovic, R.M. Mills, J.D. Thomas, E.M. Tuzcu, D. Hammer, S.E. Nissen, G.S. Francis Nitroprusside in critically ill patients with left ventricular dysfunction and aortic stenosis N Engl J Med 348 2003 1756 1763
22. W. Johnson, T. Omland, C. Hall, C. Lucas, O.L. Myking, C. Collins, M. Pfeffer, J.L. Rouleau, L.W. Stevenson Neurohormonal activation rapidly decreases after intravenous therapy with diuretics and vasodilators for class IV heart failure J Am Coll Cardiol 39 2002 1623 1629
23. J.N. Cohn, J.A. Franciosa, G.S. Francis, D. Archibald, F. Tristani, R. Fletcher, A. Montero, G. Cintron, J. Clarke, D. Hager Effect of short-term infusion of sodium nitroprusside on mortality rate in acute myocardial infarction complicated by left ventricular failure results of a Veterans Administration cooperative study N Engl J Med 306 1982 1129 1135
24. D.J. Wang, T.C. Dowling, D. Meadows, T. Ayala, J. Marshall, S. Minshall, N. Greenberg, E. Thattassery, M.L. Fisher, K. Rao, S.S. Gottlieb Nesiritide does not improve renal function in patients with chronic heart failure and worsening serum creatinine Circulation 110 2004 1620 1625
25. Natrecor Study Group R.M. Mills, T.H. LeJemtel, D.P. Horton, C. Liang, R. Lang, M.A. Silver, C. Lui, K. Chatterjee Sustained hemodynamic effects of an infusion of nesiritide (human b-type natriuretic peptide) in heart failure a randomized, double-blind, placebo-controlled clinical trial J Am Coll Cardiol 34 1999 155 162
26. Nesiritide Study Group W.S. Colucci, U. Elkayam, D.P. Horton, W.T. Abraham, R.C. Bourge, A.D. Johnson, L.E. Wagoner, M.M. Givertz, C.S. Liang, M. Neibaur, W.H. Haught, T.H. LeJemtel Intravenous nesiritide, a natriuretic peptide, in the treatment of decompensated congestive heart failure N Engl J Med 343 2000 246 253
27. VMAC Study Group J.B. Young Sustained symptom improvement with nesiritide (B-type natriuretic peptide) compared to IV nitroglycerin in patients with acute decompensated heart failure [abstract] Circulation 104 2001 II-525
28. J.D. Sackner-Bernstein, H.A. Skopicki, K.D. Aaronson Risk of worsening renal function with nesiritide in patients with acutely decompensated heart failure Circulation 111 2005 1487 1491
29. J.D. Sackner-Bernstein, M. Kowalski, M. Fox, K. Aaronson Short-term risk of death after treatment with nesiritide for decompensated heart failure a pooled analysis of randomized controlled trials JAMA 293 2005 1900 1905
30. M. Sharma, J.R. Teerlink A rational approach for the treatment of acute heart failure current strategies and future options Curr Opin Cardiol 19 2004 254 263
31. M.S. Nieminen, J. Akkila, G. Hasenfuss, F.X. Kleber, L.A. Lehtonen, V. Mitrovic, O. Nyquist, W.J. Remme Hemodynamic and neurohumoral effects of continuous infusion of levosimendan in patients with congestive heart failure J Am Coll Cardiol 36 2000 1903 1912
32. Study Investigators M.T. Slawsky, W.S. Colucci, S.S. Gottlieb, B.H. Greenberg, E. Haeusslein, J. Hare, S. Hutchins, C.V. Leier, T.H. LeJemtel, E. Loh Acute hemodynamic and clinical effects of levosimendan in patients with severe heart failure Circulation 102 2000 2222 2227
33. M. Kivikko, L. Lehtonen, W.S. Colucci Sustained hemodynamic effects of intravenous levosimendan Circulation 107 2003 81 86
34. V.S. Moiseyev, P. Poder, N. Andrejevs, M.Y. Ruda, A.P. Golikov, L.B. Lazebnik, Z.D. Kobalava, L.A. Lehtonen, T. Laine, M.S. Nieminen, K.I. Lie Safety and efficacy of a novel calcium sensitizer, levosimendan, in patients with left ventricular failure due to an acute myocardial infarction a randomized, placebo-controlled, double-blind study (RUSSLAN) Eur Heart J 23 2002 1422 1432
35. A. Mebazaa, D. Barraud, S. Welschbillig Randomized clinical trials with levosimendan Am J Cardiol 96 suppl 6A 2005 74G-79G
36. J.R. Teerlink The role of endothelin in the pathogenesis of heart failure Curr Cardiol Rep 4 2002 206 212
37. D. Aronson, A.J. Burger Neurohumoral activation and ventricular arrhythmias in patients with decompensated congestive heart failure role of endothelin PACE Pacing Clin Electrophysiol 26 2003 703 710
38. D. Aronson, A.J. Burger Neurohormonal prediction of mortality following admission for decompensated heart failure Am J Cardiol 91 2003 245 248
39. J.R. Teerlink, G. Torre-Amione A new strategy for a clinical development program in acute decompensated heart failure the Randomized Intravenous TeZosentan (RITZ) trials [abstract] J Cardiac Fail 6 suppl 2 2000 48
40. A.P. Coletta, J.G. Cleland Clinical trials update highlights of the scientific sessions of the XXIII Congress of the European Society of Cardiology: WARIS II, ESCAMI, PAFAC, RITZ-1, and TIME Eur J Heart Fail 3 2001 747 750
41. C.M. O'Connor, W.A. Gattis, K.F. Adams Jr, V. Hasselblad, B. Chandler, A. Frey, I. Kobrin, M. Rainisio, M.R. Shah, J. Teerlink, M. Gheorghiade Tezosentan in patients with acute heart failure and acute coronary syndromes results of the Randomized Intravenous TeZosentan Study (RITZ-4) J Am Coll Cardiol 41 2003 1452 1457
42. E. Kaluski, I. Kobrin, R. Zimlichman, A. Marmor, O. Krakov, O. Milo, A. Frey, S. Kaplan, R. Krakover, A. Caspi, Z. Vered, G. Cotter RITZ-5 randomized intravenous TeZosentan (an endothelin-A/B antagonist) for the treatment of pulmonary edema: a prospective, multicenter, double-blind, placebo-controlled study J Am Coll Cardiol 41 2003 204 210
43. G. Cotter, E. Kaluski, K. Stangl, R. Pacher, C. Richter, O. Milo-Cotter, L. Perchenet, I. Kobrin, S. Kaplan, M. Rainisio The hemodynamic and neurohormonal effects of low doses of tezosentan (an endothelin A/B receptor antagonist) in patients with acute heart failure Eur J Heart Fail 6 2004 601 609
44. J.R. Teerlink, J.J. McMurray, R.C. Bourge, J.G. Cleland, G. Cotter, G. Jondeau, H. Krum, M. Metra, C.M. O'Connor, J.D. Parker Tezosentan in patients with acute heart failure design of the Value of Endothelin Receptor Inhibition with Tezosentan in Acute heart failure Study (VERTIAS) Am Heart J 150 2005 46 53
45. G.S. Francis, C. Benedict, D.E. Johnstone, P.C. Kirlin, J. Nicklas, C.S. Liang, S.H. Kubo, E. Rudin-Toretsky, S. Yusuf Comparison of neuroendocrine activation in patients with left ventricular dysfunction with and without congestive heart failure a substudy of the Studies of Left Ventricular Dysfunction (SOLVD) Circulation 82 1990 1724 1729
46. S.R. Goldsmith Vasopressin antagonists in CHF ready for clinical trials? Cardiovasc Res 54 2002 13 15
47. 2 vasopressin receptor antagonist, in patients with advanced heart failure Circulation 104 2001 2417 2423
48. 2-receptor blockade with tolvaptan in patients with chronic heart failure results from a double-blind, randomized trial Circulation 107 2003 2690 2696
49. M. Gheorghiade, W.A. Gattis, C.M. O'Connor, K.F. Adams Jr, U. Elkayam, A. Barbagelata, J.K. Ghali, R.L. Benza, F.A. McGrew, J. Ouyang, C. Orlandi Effects of tolvaptan, a vasopressin antagonist, in patients hospitalized with worsening heart failure a randomized controlled trial JAMA 291 2004 1963 1971
50. M. Gheorghiade, C. Orlandi, J.C. Burnett, D. Demets, L. Grinfeld, A. Maggioni, K. Swedberg, J.E. Udelson, F. Zannad, C. Zimmer, M.A. Konstam Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the Efficacy of Vasopressin antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) J Card Fail 11 2005 260 269
51. M.S. Weinfeld, G.M. Chertow, L.W. Stevenson Aggravated renal dysfunction during intensive therapy for advanced chronic heart failure Am Heart J 138 1999 285 290
52. H.M. Krumholz, Y.T. Chen, V. Vaccarino, Y. Wang, M.J. Radford, W.D. Bradford, R.I. Horwitz Correlates and impact on outcomes of worsening renal function in patients <65 years of age with heart failure Am J Cardiol 85 2000 1110 1113
53. H. Funaya, M. Kitakaze, K. Node, T. Minamino, K. Komamura, M. Hori Plasma adenosine levels increase in patients with chronic heart failure Circulation 95 1997 1363 1365
54. S.S. Gottlieb, S.L. Skettino, A. Wolff, E. Beckman, M.L. Fisher, R. Freudenberger, T. Gladwell, J. Marshall, M. Cines, D. Bennett, E.B. Liittschwager Effects of BG9719 (CVT-124), an A1-adenosine receptor antagonist, and furosemide on glomerular filtration rate and natriuresis in patients with congestive heart failure J Am Coll Cardiol 35 2000 56 59
55. S.S. Gottlieb, D.C. Brater, I. Thomas, E. Havranek, R. Bourge, S. Goldman, F. Dyer, M. Gomez, D. Bennett, B. Ticho, E. Beckman, W.T. Abraham BG9719 (CVT-124), an A1 adenosine receptor antagonist, protects against the decline in renal function observed with diuretic therapy Circulation 105 2002 1348 1353