Status:
COMPLETED
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
Lead Sponsor:
Scios, Inc.
Conditions:
Cardiomyopathies
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Congestive heart failure (CHF) is a public health epidemic in the U.S., affecting almost 5 million Americans. It is associated with a 5-year mortality rate of 50% (according to the American Heart Asso...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2002
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00270387
Start Date
January 1 2001
End Date
January 1 2002
Last Update
December 13 2012
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