Rationale and design of the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure Trial (ASCEND-HF)

American Heart Journal

Volumn 157, Issue 2, 2009, Pages 271-277

  Hernandez, Adrian F ^a,l   O'Connor, Christopher M ^a,l   Starling, Randall C ^b,l   Reist, Craig J ^a,l   Armstrong, Paul W ^c,l   Dickstein, Kenneth ^d,l   Lorenz, Todd J ^e,l   Gibler, W Brian ^f,l   Hasselblad, Vic ^a,l   Komajda, Michel ^g,l   Massie, Barry ^h,l   McMurray, John J V ^i,l   Nieminen, Markku ^j,l   Rouleau, Jean L ^k,l   Swedberg, Karl ^a,l   Califf, Robert M ^a,l  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF ALBERTA   (Canada)

^d STAVANGER UNIVERSITY HOSPITAL   (Norway)

^e SCIOS INC   (United States)

^f UNIVERSITY OF CINCINNATI   (United States)

^g SORBONNE UNIVERSITÉ   (France)

^h UNIVERSITY OF CALIFORNIA   (United States)

ⁱ WESTERN INFIRMARY   (United Kingdom)

^j Meilahti Hospital   (Finland)

^k MONTREAL HEART INSTITUTE   (Canada)

^l UNIVERSITY OF GOTHENBURG   (Sweden)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BRAIN NATRIURETIC PEPTIDE; CREATINE KINASE MB; CREATININE; DIURETIC AGENT; DOBUTAMINE; GLYCERYL TRINITRATE; LEVOSIMENDAN; MILRINONE; NESIRITIDE; PLACEBO; TROPONIN; VASODILATOR AGENT;

ACUTE DECOMPENSATED HEART FAILURE; ACUTE HEART FAILURE; ARTICLE; BOLUS INJECTION; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIURESIS; DOUBLE BLIND PROCEDURE; DYSPNEA; HEART VENTRICLE PRESSURE; HOSPITALIZATION; HUMAN; HYPOTENSION; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MORBIDITY; MORTALITY; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SODIUM EXCRETION; VASODILATATION;

CLINICAL TRIALS, PHASE III AS TOPIC; DYSPNEA; HEART FAILURE; HOSPITALIZATION; HUMANS; MORBIDITY; NATRIURETIC AGENTS; NATRIURETIC PEPTIDE, BRAIN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 58649088449     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2008.07.031     Document Type: Article

References (22)

1. Rosamond W., Flegal K., Furie K., et al. Heart disease and stroke statistics-2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 117 (2008) e25-e146
2. McMurray J.J., and Stewart S. Epidemiology, aetiology, and prognosis of heart failure. Heart 83 (2000) 596-602
3. Krumholz H.M., Wang Y., Mattera J.A., et al. An administrative claims model suitable for profiling hospital performance based on 30-day mortality rates among patients with heart failure. Circulation 113 (2006) 1693-1701
4. Stewart S., Jenkins A., Buchan S., et al. The current cost of heart failure to the National Health Service in the UK. Eur J Heart Fail 4 (2002) 361-371
5. Adams Jr. K.F., Fonarow G.C., Emerman C.L., et al. 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 149 (2005) 209-216
6. Fonarow G.C., Adams Jr. K.F., Abraham W.T., et al. Risk stratification for in-hospital mortality in acutely decompensated heart failure: classification and regression tree analysis. JAMA 293 (2005) 572-580
7. Nieminen M.S., Brutsaert D., Dickstein K., et al. EuroHeart Failure Survey II (EHFS II): a survey on hospitalized acute heart failure patients: description of population. Eur Heart J 27 (2006) 2725-2736
8. Kosiborod M., Lichtman J.H., Heidenreich P.A., et al. National trends in outcomes among elderly patients with heart failure. Am J Med 119 (2006) 616-617
9. Thom T., Haase N., Rosamond W., et al. Heart disease and stroke statistics-2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 113 (2006) e85-e151
10. Felker G.M., Adams Jr. K.F., Konstam M.A., et al. The problem of decompensated heart failure: nomenclature, classification, and risk stratification. Am Heart J 145 (2003) S18-S25
11. Lucas C., Johnson W., Hamilton M.A., et al. Freedom from congestion predicts good survival despite previous class IV symptoms of heart failure. Am Heart J 140 (2000) 840-847
12. Adamson P.B., Magalski A., Braunschweig F., et al. Ongoing right ventricular hemodynamics in heart failure: clinical value of measurements derived from an implantable monitoring system. J Am Coll Cardiol 41 (2003) 565-571
13. Ramírez A., and Abelmann W.H. Cardiac decompensation. N Engl J Med 290 (1974) 499-501
14. Abraham W.T., Adams K.F., Fonarow G.C., et al. In-hospital mortality in patients with acute decompensated heart failure requiring intravenous vasoactive medications: an analysis from the Acute Decompensated Heart Failure National Registry (ADHERE). J Am Coll Cardiol 46 (2005) 57-64
15. The VMAC Investigators. Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial. JAMA 287 (2002) 1531-1540
16. Aaronson K.D., and Sackner-Bernstein J. Risk of death associated with nesiritide in patients with acutely decompensated heart failure. JAMA 296 (2006) 1465-1466
17. Sackner-Bernstein J.D., Kowalski M., Fox M., et al. 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
18. Mentzer Jr. R.M., Oz M.C., Sladen R.N., et al. Effect of perioperative nesiritide in patients with left ventricular dysfunction undergoing cardiac surgery. J Am Coll Cardiol 49 (2007) 716-726
19. LeLorier J., Grégoire G., Benhaddad A., et al. Discrepancies between meta-analyses and subsequent large, randomized, controlled trials. N Engl J Med 337 (1997) 536-542
20. Panel of Cardiology Experts Provides Recommendations to Scios Regarding NATRECOR [press release]. Fremont, Calif; June 13, 2005.
21. Colucci W.S., Elkayam U., Horton D.P., et al. Intravenous nesiritide, a natriuretic peptide, in the treatment of decompensated congestive heart failure. N Engl J Med 343 (2000) 246-253
22. Yancy C.W., Krum H., Massie B.M., et al. Safety and efficacy of outpatient nesiritide in patients with advanced heart failure: results of the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) Trial. Circ Heart Fail 1 (2008) 9-16