Timing and duration of interventions in clinical trials for patients with hospitalized heart failure

Circulation: Heart Failure

Volumn 6, Issue 5, 2013, Pages 1095-1101

  Marti, Catherine N ^a   Fonarow, Gregg C ^b   Gheorghiade, Mihai ^c   Butler, Javed ^a  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Clinical trial; Heart failure; Hospitalization; Prognosis

Indexed keywords

DIURETIC AGENT; NITRATE; VASODILATOR AGENT;

ACUTE CORONARY SYNDROME; ACUTE HEART INFARCTION; ARTICLE; CARDIAC RESYNCHRONIZATION THERAPY DEVICE; CLINICAL TRIAL; DEFIBRILLATOR; DYSPNEA; HEART ATRIUM FIBRILLATION; HEART FAILURE; HOSPITAL DISCHARGE; HOSPITAL PATIENT; HOSPITALIZATION; HUMAN; LONG TERM CARE; PATHOPHYSIOLOGY; PRIORITY JOURNAL;

CLINICAL TRIAL; HEART FAILURE; HOSPITALIZATION; PROGNOSIS;

CARDIOVASCULAR AGENTS; CLINICAL TRIALS AS TOPIC; DRUG ADMINISTRATION ROUTES; DRUG ADMINISTRATION SCHEDULE; HEART FAILURE; HOSPITALIZATION; HUMANS; PATIENT DISCHARGE; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME;

EID: 84887442731     PISSN: 19413289     EISSN: 19413297     Source Type: Journal    
DOI: 10.1161/CIRCHEARTFAILURE.113.000518     Document Type: Article

References (61)

1. Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J. Heart disease and stroke statistics-2010 update: A report from the american heart association. Circulation. 2010;121:e46-e215.
2. Fonarow GC, Stough WG, Abraham WT, Albert NM, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007;50:768-777.
3. Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005;149:209-216.
4. Cuffe MS, Califf RM, Adams KF Jr, Benza R, Bourge R, Colucci WS, Massie BM, O'Connor CM, Pina I, Quigg R, Silver MA, Gheorghiade M; Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) Investigators. Short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial. JAMA. 2002;287:1541-1547.
5. Gheorghiade M, Konstam MA, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Short-term clinical effects of tolvaptan, an oral vasopressin antagonist, in patients hospitalized for heart failure: the EVEREST Clinical Status Trials. JAMA. 2007;297:1332-1343.
6. Konstam MA, Gheorghiade M, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial. JAMA. 2007;297:1319-1331.
7. McMurray JJ, Teerlink JR, Cotter G, Bourge RC, Cleland JG, Jondeau G, Krum H, Metra M, O'Connor CM, Parker JD, Torre-Amione G, van Veldhuisen DJ, Lewsey J, Frey A, Rainisio M, Kobrin I; VERITAS Investigators. Effects of tezosentan on symptoms and clinical outcomes in patients with acute heart failure: the VERITAS randomized controlled trials. JAMA. 2007;298:2009-2019.
8. Mebazaa A, Nieminen MS, Packer M, Cohen-Solal A, Kleber FX, Pocock SJ, Thakkar R, Padley RJ, Põder P, Kivikko M; SURVIVE Investigators. Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial. JAMA. 2007;297:1883-1891.
9. Sackner-Bernstein JD, Kowalski M, Fox M, Aaronson K. Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials. JAMA. 2005;293:1900-1905.
10. Sackner-Bernstein JD, Skopicki HA, Aaronson KD. Risk of worsening renal function with nesiritide in patients with acutely decompensated heart failure. Circulation. 2005;111:1487-1491.
11. Packer M. Current perspectives on the design of phase II trials of new drugs for the treatment of heart failure. Am Heart J. 2000;139:S202-S206.
12. Gheorghiade M, Pang PS, O'Connor CM, Prasad K, McMurray J, Teerlink JR, Fiuzat M, Sabbah H, Komajda M. Clinical development of pharmacologic agents for acute heart failure syndromes: a proposal for a mechanistic translational phase. Am Heart J. 2011;161:224-232.
13. Gheorghiade M, Zannad F, Sopko G, Klein L, Piña IL, Konstam MA, Massie BM, Roland E, Targum S, Collins SP, Filippatos G, Tavazzi L; International Working Group on Acute Heart Failure Syndromes. Acute heart failure syndromes: current state and framework for future research. Circulation. 2005;112:3958-3968.
14. Schiff GD, Fung S, Speroff T, McNutt RA. Decompensated heart failure: symptoms, patterns of onset, and contributing factors. Am J Med. 2003;114:625-630.
15. Chaudhry SI, Wang Y, Concato J, Gill TM, Krumholz HM. Patterns of weight change preceding hospitalization for heart failure. Circulation. 2007;116:1549-1554.
16. Yamokoski LM, Haas GJ, Gans B, Abraham WT. OptiVol fluid status monitoring with an implantable cardiac device: a heart failure management system. Expert Rev Med Devices. 2007;4:775-780.
17. Conraads VM, Tavazzi L, Santini M, Oliva F, Gerritse B, Yu CM, Cowie MR. Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial. Eur Heart J. 2011;32:2266-2273.
18. Vollmann D, Nägele H, Schauerte P, Wiegand U, Butter C, Zanotto G, Quesada A, Guthmann A, Hill MR, Lamp B; European InSync Sentry Observational Study Investigators. Clinical utility of intrathoracic impedance monitoring to alert patients with an implanted device of deteriorating chronic heart failure. Eur Heart J. 2007;28:1835-1840.
19. Zile MR, Bennett TD, St John Sutton M, Cho YK, Adamson PB, Aaron MF, Aranda JM Jr, Abraham WT, Smart FW, Stevenson LW, Kueffer FJ, Bourge RC. Transition from chronic compensated to acute decompensated heart failure: pathophysiological insights obtained from continuous monitoring of intracardiac pressures. Circulation. 2008;118:1433-1441.
20. Ritzema J, Troughton R, Melton I, Crozier I, Doughty R, Krum H, Walton A, Adamson P, Kar S, Shah PK, Richards M, Eigler NL, Whiting JS, Haas GJ, Heywood JT, Frampton CM, Abraham WT; Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS) Study Group. Physician-directed patient self-management of left atrial pressure in advanced chronic heart failure. Circulation. 2010;121:1086-1095.
21. Solomon SD, Anavekar N, Skali H, McMurray JJ, Swedberg K, Yusuf S, Granger CB, Michelson EL, Wang D, Pocock S, Pfeffer MA; Candesartan in Heart Failure Reduction in Mortality (CHARM) Investigators. Influence of ejection fraction on cardiovascular outcomes in a broad spectrum of heart failure patients. Circulation. 2005;112:3738-3744.
22. Tribouilloy C, Rusinaru D, Leborgne L, Mahjoub H, Szymanski C, Houpe D, Béguin M, Peltier M. In-hospital mortality and prognostic factors in patients admitted for new-onset heart failure with preserved or reduced ejection fraction: a prospective observational study. Arch Cardiovasc Dis. 2008;101:226-234.
23. Verhaert D, Mullens W, Borowski A, Popović ZB, Curtin RJ, Thomas JD, Tang WH. Right ventricular response to intensive medical therapy in advanced decompensated heart failure. Circ Heart Fail. 2010;3:340-346.
24. Nieminen MS, Brutsaert D, Dickstein K, Drexler H, Follath F, Harjola VP, Hochadel M, Komajda M, Lassus J, Lopez-Sendon JL, Ponikowski P, Tavazzi L; EuroHeart Survey Investigators; Heart Failure Association, European Society of Cardiology. EuroHeart Failure Survey II (EHFS II): a survey on hospitalized acute heart failure patients: description of population. Eur Heart J. 2006;27:2725-2736.
25. Binanay C, Califf RM, Hasselblad V, O'Connor CM, Shah MR, Sopko G, Stevenson LW, Francis GS, Leier CV, Miller LW; ESCAPE Investigators and ESCAPE Study Coordinators. Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial. JAMA. 2005;294:1625-1633.
26. Schrier RW, Abraham WT. Hormones and hemodynamics in heart failure. N Engl J Med. 1999;341:577-585.
27. Aronson D, Burger AJ. Neurohormonal prediction of mortality following admission for decompensated heart failure. Am J Cardiol. 2003;91:245-248.
28. Triposkiadis F, Karayannis G, Giamouzis G, Skoularigis J, Louridas G, Butler J. The sympathetic nervous system in heart failure physiology, pathophysiology, and clinical implications. J Am Coll Cardiol. 2009;54:1747-1762.
29. Potocki M, Breidthardt T, Reichlin T, Morgenthaler NG, Bergmann A, Noveanu M, Schaub N, Uthoff H, Freidank H, Buser L, Bingisser R, Christ M, Mebazaa A, Mueller C. Midregional pro-adrenomedullin in addition to b-type natriuretic peptides in the risk stratification of patients with acute dyspnea: an observational study. Crit Care. 2009;13:R122.
30. Horwich TB, Patel J, MacLellan WR, Fonarow GC. Cardiac troponin I is associated with impaired hemodynamics, progressive left ventricular dysfunction, and increased mortality rates in advanced heart failure. Circulation. 2003;108:833-838.
31. Peacock WF 4th, De Marco T, Fonarow GC, Diercks D, Wynne J, Apple FS, Wu AH; ADHERE Investigators. Cardiac troponin and outcome in acute heart failure. N Engl J Med. 2008;358:2117-2126.
32. Torre-Amione G, Kapadia S, Benedict C, Oral H, Young JB, Mann DL. Proinflammatory cytokine levels in patients with depressed left ventricular ejection fraction: a report from the Studies of Left Ventricular Dysfunction (SOLVD). J Am Coll Cardiol. 1996;27:1201-1206.
33. Mueller C, Laule-Kilian K, Christ A, Brunner-La Rocca HP, Perruchoud AP. Inflammation and long-term mortality in acute congestive heart failure. Am Heart J. 2006;151:845-850.
34. Sato Y, Takatsu Y, Kataoka K, Yamada T, Taniguchi R, Sasayama S, Matsumori A. Serial circulating concentrations of C-reactive protein, interleukin (IL)-4, and IL-6 in patients with acute left heart decompensation. Clin Cardiol. 1999;22:811-813.
35. Rehman SU, Mueller T, Januzzi JL Jr. Characteristics of the novel interleukin family biomarker ST2 in patients with acute heart failure. J Am Coll Cardiol. 2008;52:1458-1465.
36. Ungvári Z, Gupte SA, Recchia FA, Bátkai S, Pacher P. Role of oxidativenitrosative stress and downstream pathways in various forms of cardiomyopathy and heart failure. Curr Vasc Pharmacol. 2005;3:221-229.
37. Tang WH, Tong W, Troughton RW, Martin MG, Shrestha K, Borowski A, Jasper S, Hazen SL, Klein AL. Prognostic value and echocardiographic determinants of plasma myeloperoxidase levels in chronic heart failure. J Am Coll Cardiol. 2007;49:2364-2370.
38. Tamariz L, Harzand A, Palacio A, Verma S, Jones J, Hare J. Uric acid as a predictor of all-cause mortality in heart failure: a meta-analysis. Congest Heart Fail. 2011;17:25-30.
39. Pascual-Figal DA, Hurtado-Martínez JA, Redondo B, Antolinos MJ, Ruiperez JA, Valdes M. Hyperuricaemia and long-term outcome after hospital discharge in acute heart failure patients. Eur J Heart Fail. 2007;9:518-524.
40. Radauceanu A, Ducki C, Virion JM, Rossignol P, Mallat Z, McMurray J, Van Veldhuisen DJ, Tavazzi L, Mann DL, Capiaumont-Vin J, Li M, Hanriot D, Zannad F. Extracellular matrix turnover and inflammatory markers independently predict functional status and outcome in chronic heart failure. J Card Fail. 2008;14:467-474.
41. Shirakabe A, Asai K, Hata N, Yokoyama S, Shinada T, Kobayashi N, Mizuno K. Clinical significance of matrix metalloproteinase (MMP)-2 in patients with acute heart failure. Int Heart J. 2010;51:404-410.
42. Fonarow GC, Peacock WF, Horwich TB, Phillips CO, Givertz MM, Lopatin M, Wynne J; ADHERE Scientific Advisory Committee and Investigators. Usefulness of B-type natriuretic peptide and cardiac troponin levels to predict in-hospital mortality from ADHERE. Am J Cardiol. 2008;101:231-237.
43. Fonarow GC, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride ML, Inge PJ, Mehra MR, O'Connor CM, Reynolds D, Walsh MN, Yancy CW. 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;122:585-596.
44. Lee DS, Austin PC, Rouleau JL, Liu PP, Naimark D, Tu JV. Predicting mortality among patients hospitalized for heart failure: derivation and validation of a clinical model. JAMA. 2003;290:2581-2587.
45. Fonarow GC, Adams KF Jr, Abraham WT, Yancy CW, Boscardin WJ; ADHERE Scientific Advisory Committee, Study Group, and Investigators. Risk stratification for in-hospital mortality in acutely decompensated heart failure: classification and regression tree analysis. JAMA. 2005;293:572-580.
46. Fonarow GC, Yancy CW, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride ML, Mehra MR, O'Connor CM, Reynolds D, Walsh MN. Heart failure care in the outpatient cardiology practice setting: findings from IMPROVE HF. Circ Heart Fail. 2008;1:98-106.
47. Manzano-Fernandez S, Januzzi JL Jr, Boronat-Garcia M, Bonaque-Gonzalez JC, Truong QA, Pastor-Perez FJ, Munoz-Esparza C, Pastor P, Albaladejo-Oton MD, Casas T, Valdes M, Pascual-Figal DA. Beta-trace protein and cystatin c as predictors of long-term outcomes in patients with acute heart failure. J Am Coll Cardiol. 2011;57:849-858.
48. Aghel A, Shrestha K, Mullens W, Borowski A, Tang WH. Serum neutrophil gelatinase-associated lipocalin (NGAL) in predicting worsening renal function in acute decompensated heart failure. J Card Fail. 2010;16:49-54.
49. Solomon SD, Dobson J, Pocock S, Skali H, McMurray JJ, Granger CB, Yusuf S, Swedberg K, Young JB, Michelson EL, Pfeffer MA; Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) Investigators. Influence of nonfatal hospitalization for heart failure on subsequent mortality in patients with chronic heart failure. Circulation. 2007;116:1482-1487.
50. Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J. 2007;154:260-266.
51. Kaul P, McAlister FA, Ezekowitz JA, Grover VK, Quan H. Ethnic differences in 1-year mortality among patients hospitalised with heart failure. Heart. 2011;97:1048-1053.
52. Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Pieper K, Sun JL, Yancy C, Young JB; OPTIMIZE-HF Investigators and Hospitals. Association between performance measures and clinical outcomes for patients hospitalized with heart failure. JAMA. 2007;297:61-70.
53. Krantz MJ, Havranek EP, Haynes DK, Smith I, Bucher-Bartelson B, Long CS. Inpatient initiation of beta-blockade plus nurse management in vulnerable heart failure patients: a randomized study. J Card Fail. 2008;14:303-309.
54. Gattis WA, O'Connor CM, Gallup DS, Hasselblad V, Gheorghiade M; IMPACT-HF Investigators and Coordinators. Predischarge initiation of carvedilol in patients hospitalized for decompensated heart failure: results of the Initiation Management Predischarge: Process for Assessment of Carvedilol Therapy in Heart Failure (IMPACT-HF) trial. J Am Coll Cardiol. 2004;43:1534-1541.
55. Fonarow GC, Abraham WT, Albert NM, Stough WG, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy C, Young JB. Carvedilol use at discharge in patients hospitalized for heart failure is associated with improved survival: An analysis from organized program to initiate lifesaving treatment in hospitalized patients with heart failure (optimize-hf). Am Heart J. 2007;153:82 e81-11.
56. Swedberg K, Held P, Kjekshus J, Rasmussen K, Rydén L, Wedel H. Effects of the early administration of enalapril on mortality in patients with acute myocardial infarction. Results of the Cooperative New Scandinavian Enalapril Survival Study II (CONSENSUS II). N Engl J Med. 1992;327:678-684.
57. Peacock WFt, Fonarow GC, Emerman CL, Mills RM, Wynne J. Impact of early initiation of intravenous therapy for acute decompensated heart failure on outcomes in adhere. Cardiology. 2007;107:44-51.
58. Wong Y, Fonarow G, Mi X, Mills R, Peacock F, Curtis L, Qualls L, Klaskala W, Hernandez AF. Time to intravenous therapy and clinical outcomes in older patients presenting with acute decompensated heart failure: An analysis of the adhere registry emergency molule. J Am Coll Cardiol. 2013;61:E622.
59. Mitrovic V, Lüss H, Nitsche K, Forssmann K, Maronde E, Fricke K, Forssmann WG, Meyer M. Effects of the renal natriuretic peptide urodilatin (ularitide) in patients with decompensated chronic heart failure: a double-blind, placebo-controlled, ascending-dose trial. Am Heart J. 2005;150:1239.
60. Chen HH, Glockner JF, Schirger JA, Cataliotti A, Redfield MM, Burnett JC Jr. Novel protein therapeutics for systolic heart failure: chronic subcutaneous B-type natriuretic peptide. J Am Coll Cardiol. 2012;60:2305-2312.
61. Gheorghiade M, Albaghdadi M, Zannad F, Fonarow GC, Böhm M, Gimpelewicz C, Botha J, Moores S, Lewis EF, Rattunde H, Maggioni A; ASTRONAUT Investigators and Study Coordinators. Rationale and design of the multicentre, randomized, double-blind, placebo-controlled Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT). Eur J Heart Fail. 2011;13:100-106.