ASCEND-HF Trial

Trial Details

Acronym: Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure

Purpose: Evaluated the effect of nesiritide, in addition to standard care, on rates of self-reported dyspnea at 6 and 24 hours, rehospitalization, death and renal dysfunction

Format: randomized, double-blind, placebo-controlled

Treatment Group: nesiritide

Control Group: placebo

Number of Patients: 7,141

Inclusion Criteria: hospitalized with acute heart failure

Exclusion Criteria:

• High risk of hypotension
• Other contraindications for vasodilators
• Treatment with dobutamine
• Treatment with milrinone or levosimendan within the previous 30 days
• Persistent uncontrolled hypertension
• Acute coronary syndrome
• Normal level of bnp or n-terminal pro-bnp
• Severe pulmonary disease
• End-stage renal disease during receipt of renal-replacement therapy
• Clinically significant anemia

Primary Endpoints:

• Change in dyspnea at 6 and 24 hours
• Composite end point of rehospitalization for heart failure or death within 30 days

Summary:

In the ASCEND-HF trial, while nesiritide did improve the symptom of dyspnea better than placebo, there was no reduction in 30 day rehospitalization and no mortality benefit. Hypotension was significant in the nesiritide group.

Original Publication:

O’Conner CM, et al. N Engl J Med. 2011;doi: 10.1056/NEJMoa1100171.