- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00271557
A Study to Develop Additional Safety and Clinical Experience With NATRECOR hBNP (Nesiritide) in the Treatment of Patients With Worsening Congestive Heart Failure Who Require Inpatient Intravenous Therapy With Medications That Influence the Tone and Caliber of Blood Vessels
March 3, 2011 updated by: Scios, Inc.
A Randomized, Open-Label, Active-Controlled, Multicenter Phase III Safety Study of Two Doses of NATRECOR hBNP (Nesiritide) Administered as a Continuous Infusion in the Treatment of Decompensated CHF
The purpose of this safety study is to evaluate NATRECOR® hBNP (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure), in subjects with worsening congestive heart failure for whom inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels is deemed appropriate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The data from these previous studies suggest that doses of NATRECOR® 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.
The purpose of this safety study is to evaluate NATRECOR® hBNP in subjects with symptomatic, decompensated congestive heart failure for whom inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels (other than, or in addition to, IV diuretics) is deemed appropriate.
This is a multi-center, randomized, open-label, safety study designed to compare two doses of NATRECOR® hBNP for the treatment of decompensated congestive heart failure.
One treatment group receives NATRECOR® hBNP fixed-dose infusion IV bolus of 0.3 µg/kg followed by a 0.015 µg/kg/min infusion; group two receives IV bolus of 0.6 µg/kg followed by a 0.03 µg/kg/min infusion.
The duration of NATRECOR® hBNP therapy is determined by the attending physician.
The study hypothesis is that doses of NATRECOR® hBNP in the range of 0.015 to 0.03 µg/kg/min provide an optimal safety/efficacy profile for the treatment of decompensated CHF.
One treatment group receives NATRECOR® hBNP fixed-dose infusion IV bolus of 0.3 µg/kg followed by a 0.015 µg/kg/min infusion; group two receives IV bolus of 0.6 µg/kg followed by a 0.03 µg/kg/min infusion.
The duration of NATRECOR® hBNP therapy is determined by the attending physician.
Study Type
Interventional
Enrollment (Actual)
305
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:
- Patients with a previous history of chronic congestive heart failure (CHF)
- presenting with symptomatic, decompensated CHF for inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels (other than, or in addition to, diuretics)
Exclusion Criteria:
- Patients with myocardial ischemia within the past 48 hours
- having significant valvular stenosis, obstructive cardiomyopathy, constrictive pericarditis or primary pulmonary hypertension
- being treated with intravenous (IV) therapy with medications that influence the tone and caliber of blood vessels for > 4 hours for this episode of CHF
- already being treated with IV therapy with medications that influence the tone and caliber of blood vessels that cannot be discontinued
- having cardiogenic shock, systolic blood pressure consistently < 90 mm Hg or other significant blood circulation instability.
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: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Changes in symptoms and signs of CHF after 6 hours and after 24 hours of treatment with NATRECOR® hBNP.
|
Secondary Outcome Measures
Outcome Measure |
---|
Adverse events, vital signs
|
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
January 1, 1997
Study Completion (Actual)
December 1, 1997
Study Registration Dates
First Submitted
December 30, 2005
First Submitted That Met QC Criteria
December 30, 2005
First Posted (Estimate)
January 2, 2006
Study Record Updates
Last Update Posted (Estimate)
March 4, 2011
Last Update Submitted That Met QC Criteria
March 3, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005203
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.
Clinical Trials on Heart Failure, Congestive
-
Adnan Kastrati, MDBiotronik SE & Co. KGCompleted
-
Signature Medical, Inc.WithdrawnHeart Failure,Congestive
-
Echosense Ltd.WithdrawnCongestive Heart Failure (CHF)United States
-
Corthera, Inc.(formerly BAS Medical, Inc.), a member...TerminatedCongestive Heart Failure (CHF)Russian Federation
-
Meir Medical CenterUnknown
-
Nihon KohdenTerminatedHeart Failure,CongestiveUnited States
-
ELA Medical, Inc.Approved for marketing
-
Abbott Medical DevicesCompletedCongestive Heart Failure TreatedItaly
-
Echosense Ltd.Terminated
-
Magenta Medical Ltd.TerminatedCongestive Heart Failure | Heart Failure, Congestive | Acute Heart FailureCroatia, Belgium, Serbia
Clinical Trials on nesiritide
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health... and other collaboratorsCompletedLeft Ventricular Diastolic DysfunctionUnited States
-
Janssen Pharmaceutical K.K.CompletedHeart Failure, CongestiveJapan
-
Mayo ClinicNational Institutes of Health (NIH)Completed
-
Xian-Janssen Pharmaceutical Ltd.CompletedCongestive Heart Failure | Heart DecompensationChina
-
Mayo ClinicScios, Inc.CompletedKidney Diseases | Congestive Heart Failure | CardiomyopathyUnited States
-
Ejaz, Abulate A, MDUnknownCardiovascular Disease | Death | Acute Renal FailureUnited States
-
University of Wisconsin, MadisonScios, Inc.CompletedHeart Failure, CongestiveUnited States
-
The Baruch Padeh Medical Center, PoriyaUnknownCoronary Artery DiseaseIsrael
-
Scios, Inc.CompletedHeart Failure, Congestive | Heart Decompensation
-
Shanghai Zhongshan HospitalUnknownCongestive Heart Failure | Mechanical Ventilation | Cardiac Function | Using Nesiritide | Venous ReturnChina