- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00288730
A Study of Two Doses of Intravenous NATRECOR hBNP (Nesiritide) in Patients With Worsening Congestive Heart Failure Who Have Difficulty Breathing at Rest
June 9, 2011 updated by: Scios, Inc.
A Randomized, Double-Blinded, Placebo-Controlled Study of Two Doses of NATRECOR hBNP (Nesiritide) Administered as a Continuous Infusion in Subjects With Decompensated CHF
The purpose of this study is to assess the safety and efficacy of two doses of intravenous NATRECOR® hBNP (a recombinant form of the natural human peptide normally secreted by the heart) versus placebo in the treatment of patients with symptomatic, decompressed congestive heart failure (CHF).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Human studies reported by SJ Holmes et al, 1993, AM Richards et al, 1993 and M. Yoshimara et al, 1991 show that administration of externally produced hBNP produces vasodilation; antagonism of the hormone system that helps regulate long term blood pressure and blood volume in the body; and an increase in urine output containing large amounts of salt.
These studies suggest hBNP may be a potent agent for the treatment of acute congestive heart failure (CHF) with a unique combination of desirable effects on the flow of blood throughout the body; the hormones secreted by the nervous system; and support of copious salt outputs by the renal system not provided by currently available therapies.
Plasma hBNP levels are elevated in CHF and hBNP may be one of the body's natural compensatory mechanisms to augment cardiac functions in a failing heart.
NATRECOR® hBNP is Scios' proprietary form of hBNP and it is identical to the amino acid sequence in the naturally occurring hormone.
This is a randomized, double-blinded, placebo-controlled, multicenter study to determine the efficacy of two distinct doses of NATRECOR® hBNP in patients with symptomatic, decompensated congestive heart failure to decrease pulmonary capillary wedge pressure, as measured by a blinded comparison to placebo after 6 hours of treatment.
Patients are randomized to receive either a placebo or one of two doses (0.015 or 0.03 µg/kg/min) of NATRECOR® hBNP.
The study hypothesis is that NATRECOR ® hBNP is well tolerated and an effective agent for the short-term management of hospitalized patients with symptomatic, decompensated CHF.
Patients are randomized to receive either a placebo or one of two doses (0.015 or 0.03 µg/kg/min) of NATRECOR® hBNP.
Doses are administered one time only, an intravenous loading bolus, followed by continuous intravenous infusion for 6 hours.
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- History of chronic congestive heart failure (CHF)
- symptomatic, decompensated CHF for which intravenous therapy is deemed appropriate for the hospitalized patient
- documentation of pulmonary capillary wedge pressure (PCWP) >= 18 mm Hg, Cl <= 2.7 mL/min/m² and systolic blood pressure >= 90 mm Hg with consistent baseline hemodynamic measurements.
Exclusion Criteria:
- Had a myocardial infarction within the previous 48 hours or unstable angina
- stroke within the previous 3 months or other evidence of significantly compromised central nervous system perfusion
- has significant valvular stenosis hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, biopsy-proven active myocarditis, or complex congenital heart disease
- receiving ongoing treatment with an intravenous vasostrictive agent for this episode of decompressed CHF that could not be discontinued for an appropriate washout period to permit the reassessment of baseline hemodynamic and clinical status prior to initiating drug study
- clinical status so unstable that the subject can not tolerate placement of a Swan-Ganz catheter.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
nesiritide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Hemodynamic effects assessed by an increase in cardiac output without an increase in heart rate, measured at 1.5, 3, 4.5 and 6 hours.
|
Secondary Outcome Measures
Outcome Measure |
---|
Hemodynamic improvements sustained throughout at least 24 hours of infusion: improvements in overall clinical status and specific signs and symptoms of CHF after 6 hours of treatment; reduction in plasma aldosterone levels.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1996
Study Completion (Actual)
August 1, 1997
Study Registration Dates
First Submitted
February 3, 2006
First Submitted That Met QC Criteria
February 3, 2006
First Posted (Estimate)
February 8, 2006
Study Record Updates
Last Update Posted (Estimate)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 9, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005197
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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