A Study of Short-Term Outcomes and Economic Impact For Patients With Worsening Congestive Heart Failure When Natrecor (Nesiritide) is Added to Standard-Care Therapy, Compared to Administration of Placebo With Standard-Care Therapy

• Status: Completed
• Trial end date: 2002-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study is to compare the clinical effects, safety profile, and economic impact of standard therapy plus Natrecor® (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) to standard therapy plus placebo in patients who present to the Emergency Department with worsening congestive heart failure (CHF) and are treated in the Emergency Department /Observation Unit.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scios, Inc.
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• Patients with a history consistent with congestive heart failure (either chronic or new onset) with fluid overload or elevated cardiac filling pressures by clinical diagnosis

• having a need for observation and intravenous therapy for at least 12 hours, primarily for the treatment of acutely worsening heart failure

• having dyspnea (difficulty breathing and shortness of breath) at rest, while supine, or immediately upon minimal exertion, and evidence of heart failure rather than pulmonary disease as the primary cause for the dyspnea

• having jugular venous distension, abdominal discomfort (such as decreased appetite or nausea) and a weight gain of at least 5 pounds in the previous month

• having chest x-ray findings indicative of heart failure, or rales (sounds associated with fluid in the lung cavity) heard on physical examination.

Exclusion Criteria:

• Patients having a clinical status so acutely unstable that invasive monitoring or mechanical ventilation is required

• admitted to Emergency Department/Observation Unit primarily for a diagnostic evaluation (such as ruling out myocardial infarction or to diagnose irregular heart beats)

• having systolic blood pressure consistently less than 90 mm Hg

• having cardiogenic shock (a sudden decrease in blood pressure that results in decreased perfusion of body tissues and organs), volume depletion, or any other clinical condition that would contraindicate the administration of intravenous diuretics, ACE inhibitors, or an intravenous agent with potent vasodilating properties

• having a circumstance recognized at baseline evaluation that would definitely prohibit discharge to home from the Emergency Department/Observation Unit in less than 24 hours.