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

• Published in: The American heart journal 2009-02, Vol.157 (2), p.271-277
• Main Authors: Hernandez, Adrian F., MD, MHS, O'Connor, Christopher M., MD, Starling, Randall C., MD, MPH, Reist, Craig J., PhD, Armstrong, Paul W., MD, Dickstein, Kenneth, MD, Lorenz, Todd J., MD, Gibler, W. Brian, MD, Hasselblad, Vic, PhD, Komajda, Michel, MD, Massie, Barry, MD, McMurray, John J.V., MD, Nieminen, Markku, MD, Rouleau, Jean L., MD, Swedberg, Karl, MD, Califf, Robert M., MD
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Biomarkers; Brain/therapeutic use; Cardiac and Cardiovascular Systems; Cardiology. Vascular system; Cardiovascular; Clinical outcomes; Clinical trials; Comorbidity; Disease; Drug dosages; Drug therapy; Dyspnea - drug therapy; Dyspnea - etiology; Dyspnea/drug therapy/etiology; Heart; Heart attacks; Heart failure; Heart Failure - drug therapy; Heart Failure - epidemiology; Heart failure, cardiogenic pulmonary edema, cardiac enlargement; Heart Failure/drug therapy/epidemiology; Hospitalization; Humans; Kardiologi; Likert scale; Medical sciences; Morbidity; Mortality; Natriuretic Agents - therapeutic use; Natriuretic Peptide; Natriuretic Peptide, Brain - therapeutic use; Public health; Research Design; Studies; Substance abuse treatment; Survival Analysis; Treatment Outcome
• ISSN: 0002-8703; 1097-6744; 1097-6744
• DOI: 10.1016/j.ahj.2008.07.031

Background Acute decompensated heart failure (ADHF) is a major public health burden with significant mortality and morbidity. Nesiritide is a recombinantly produced intravenous formulation of human B-type natriuretic peptide that promotes vasodilation and increases salt and water excretion, which results in reduced cardiac filling pressures. Prior studies have shown that dyspnea is improved in patients with ADHF 3 hours after nesiritide infusion with significant dose-related reductions in cardiac filling pressures and systemic vascular resistance without significant arrhythmias. However, the effect of nesiritide on dyspnea at 6 or 24 hours is unknown, and no clinical outcome trials have been done to provide a reliable estimate of the effect of nesiritide on morbidity and mortality. Methods The Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure trial (ASCEND-HF) is a phase III study evaluating the efficacy and safety of nesiritide in patients with ADHF. Patients hospitalized for hear failure will be randomly assigned to receive either intravenous nesiritide or matching placebo for 24 hours to 7 days. The 2 coprimary end points are (1) assessment of acute dyspnea at 6 or 24 hours and (2) death or rehospitalization for hear failure within 30 days. A total of 7,000 patients will be enrolled worldwide between 2007 and 2010. Conclusions The data from the ASCEND-HF trial will establish whether nesiritide safely improves acute dyspnea as well as morbidity and mortality at 30 days.