Scios Inc. has announced enrolment of the first patients in ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure), a trial which will involve heart failure experts and practitioners at approximately 600 sites in the United States and throughout the world.
ASCEND-HF is being conducted by the Duke Clinical Research Institute (DCRI), and is designed to further assess the long-term clinical outcomes and benefit/risk profile of Natrecor (nesiritide) in patients with acutely decompensated heart failure (ADHF).
"This landmark, 7,000-patient trial is a major advancement in adding to our collective understanding of ADHF, and it is a real privilege to be able to conduct such a robust study together with academic colleagues around the world," said Robert Califf, MD, chair of the trial, director of the Duke Translational Medicine Institute (DTMI) and vice chancellor for clinical research and professor of medicine in the division of cardiology at Duke University Medical Centre. "Given the fact that nesiritide is one of the few options in relieving the symptoms of these critically ill patients, we have the opportunity to gain a greater understanding of the overall profile of the drug."
In this randomised, double-blind, placebo-controlled, parallel-group, multi-centre outcomes trial, approximately 7,000 patients with ADHF will be randomised to receive placebo or Natrecor for a minimum of 24 hours up to a maximum of seven days, in addition to standard care.
The primary objective of the trial is to assess whether treatment with Natrecor in addition to standard care, compared with placebo plus standard care, improves patient outcomes, as measured by reduction in the composite of heart failure rehospitalization and all-cause mortality through 30 days; or improves heart failure symptoms, as measured by a patient self-assessed dyspnea, or shortness of breath, scale at six and 24 hours after Natrecor initiation.
Additional clinical endpoints include measuring improvement in patient self-assessed overall well-being at six or 24 hours after Natrecor initiation; increase in the number of days alive and outside of the hospital at 30 days; and reduction of 30-day composite cardiovascular rehospitalization and cardiovascular mortality.
DCRI, the academic clinical research organization within the DTMI at Duke University Medical Centre, will collaborate with the Cleveland Clinic Cardiovascular Coordinating Centre (C5) in managing the trial.