Status:
COMPLETED
A Study Comparing Blood Flow and Clinical and Safety Effects of the Addition of Natrecor (Nesiritide), Placebo or Intravenous Nitroglycerin to Standard Care for the Treatment of Worsening Congestive Heart Failure.
Lead Sponsor:
Scios, Inc.
Conditions:
Symptomatic Decompensated Congestive Heart Failure
Congestive Heart Failure in Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the hemodynamic (blood flow) and clinical effects of the study drug, Natrecor (nesiritide, a recombinant form of the natural human peptide normally secreted by ...
Detailed Description
Advanced congestive heart failure (CHF) accounts for over 1 million hospital admissions yearly in the U.S. and is also associated with a high rate of readmission to the hospital within a short turn-ar...
Eligibility Criteria
Inclusion
- Patients with dyspnea (difficulty breathing and shortness of breath) at rest, while supine, or immediately upon minimal activity such as talking, eating, or bathing
- having evidence of heart disease, rather than pulmonary disease, as the primary cause for the dyspnea (by demonstrating at least two of the following: jugular venous distension, paroxysmal nocturnal dyspnea or 2-pillow orthopnea within 72 hours before the start of study drug, abdominal discomfort due to hepatosplanchnic congestion, chest x-ray with findings indicative of heart failure)
- having elevated cardiac filling pressures either by clinical estimate in non-catheterized patients, or a measured pulmonary capillary wedge pressure (PCWP) \>= 20 mm Hg in catheterized patients
- requiring hospitalization and intravenous therapy for at least 24 hours for the treatment of acutely decompensated heart failure.
Exclusion
- NPatients 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 an intravenous agent with potent vasodilating properties
- having their most recent pulmonary capillary wedge pressure (PCWP) \< 20 mm Hg within 24 hours before randomization
- having a clinical status so acutely unstable that the potential subject could not tolerate placement of a right heart catheter or the 3-hour placebo period
- unable to have intravenous nitroglycerin withheld (e.g., intravenous nitroglycerin for management of an acute coronary syndrome).
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2000
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT00270374
Start Date
October 1 1999
End Date
August 1 2000
Last Update
June 10 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.