Heart Failure, CongestivePhase 3NCT00271557
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
A Phase 3 study testing nesiritide in people with Heart Failure, Congestive and Heart Decompensation, run by Scios, Inc..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Heart Decompensation
- What is being tested?
- nesiritide
- How many people
- 305 participants
- Where
- No sites listed yet
- Study dates
- Jan 1997to Dec 1997
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Congestive, Heart Decompensation
- Being tested
- nesiritide
- Keywords
- Heart Failure, Renal Dysfunction, Cardiomyopathy, Heart Decompensation, Dyspnea Paroxysmal.
- Medical subject headings
- Heart Failure, Renal Insufficiency, Cardiomyopathies, Dyspnea, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nesiritideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in symptoms and signs of CHF after 6 hours and after 24 hours of treatment with NATRECOR® hBNP.
Secondary outcomes (1)
Adverse events, vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2006 (estimated)
- Study startJan 1997
- Study completionDec 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scios, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scios, Inc. Clinical Trial, Study director, Scios, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271557
- Sponsor's protocol ID
- CR005203
- Status last verified
- Mar 2011
- First submitted
- 30 Dec 2005
- Last updated
- 4 Mar 2011
- Results posted
- No
Publications
Mills RM, LeJemtel TH, Horton DP, Liang C, Lang R, Silver MA, Lui C, Chatterjee K. Sustained hemodynamic effects of an infusion of nesiritide (human b-type natriuretic peptide) in heart failure: a randomized, double-blind, placebo-controlled clinical trial. Natrecor Study Group. J Am Coll Cardiol. 1999 Jul;34(1):155-62. doi: 10.1016/s0735-1097(99)00184-9.
PubMed 10400005
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00271557
- Acronym / sponsor ID
- CR005203
- Conditions
- Heart Failure, Congestive, Heart Decompensation
- Keywords
- Heart Failure, Renal Dysfunction, Cardiomyopathy, Heart Decompensation, Dyspnea Paroxysmal.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Scios, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 1997
- Study completion
- Dec 1997 (actual)
- First posted
- 2 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nesiritide | Drug | – |
Primary outcome
Changes in symptoms and signs of CHF after 6 hours and after 24 hours of treatment with NATRECOR® hBNP.
1 secondary outcome
Adverse events, vital signs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
- Results publication: PubMed 10400005Mills RM, LeJemtel TH, Horton DP, Liang C, Lang R, Silver MA, Lui C, Chatterjee K. Sustained hemodynamic effects of an infusion of nesiritide (human b-type natriuretic peptide) in heart failure: a randomized, double-blind, placebo-controlled clinical trial. Natrecor Study Group. J Am Coll Cardiol. 1999 Jul;34(1):155-62. doi: 10.1016/s0735-1097(99)00184-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scios, Inc. Clinical Trial study director
Scios, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nesiritide in people with Heart Failure, Congestive and Heart Decompensation, run by Scios, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in symptoms and signs of CHF after 6 hours and after 24 hours of treatment with NATRECOR® hBNP.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00271557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2011.