Congestive Heart FailurePhase 2NCT00119691
Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction
A Phase 2 study testing Nesiritide in people with Congestive Heart Failure and Renal Insufficiency, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Renal Insufficiency
- What is being tested?
- Nesiritide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Nov 2005
- Phase
- Phase 2
- 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
- Decompensated heart failure hospitalization with at least 1 symptom and 1 sign of elevated filling pressures
- Admission estimated creatinine clearance =< 50 cc/min.
Who cannot join
- Systolic blood pressure < 85 mm Hg
- Cardiogenic shock
- Volume depletion
- Myocardial infarction, unstable angina within last 30 days
- Significant valvular stenosis, hypertrophic/restrictive cardiomyopathy, or constrictive pericarditis
- Chronic hemodialysis
- Anticipated major procedure during hospitalization i.e. left heart catheterization, surgery, or transplantation
- Enrolled in another research protocol within last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.
- Conditions
- Congestive Heart Failure, Renal Insufficiency
- Being tested
- Nesiritide
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NesiritideDrug
Also called Natrecor
Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved.
| Study group | Role | What they receive |
|---|---|---|
| Nesiritide + standard of care | Experimental | Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved. Receives: Drug: Nesiritide |
| Standard of care | Active comparator | Standard of care until adequate diuresis achieved Receives: Drug: Nesiritide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Measured: within 7 days after randomization
Secondary outcomes (5)
Weight loss
Measured: Within 7 days from randomization
Days to optimal volume status
Measured: From randomization till day 7 or sooner
Concomitant diuretic use
Measured: Within 7 days from randomization
Global symptom assessment
Measured: 24 hrs and 3 days after randomization
Length of stay
Measured: From admission to discharge or day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startApr 2003
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Scios, Inc.
- Responsible party
- Principal investigator, Anju Nohria, Brigham and Women's Hospital
- Investigators
- Anju Nohria, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119691
- Sponsor's protocol ID
- 2003-P00235
- Status last verified
- Sep 2013
- First submitted
- 7 Jul 2005
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction
- ClinicalTrials.gov ID
- NCT00119691
- Acronym / sponsor ID
- 2003-P00235
- Conditions
- Congestive Heart Failure, Renal Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Scios, Inc.
- Study start
- Apr 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 14 Jul 2005 (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 researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nesiritide + standard of care | Experimental | Drug: NesiritideNesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved. |
| Standard of care | Active comparator | Drug: NesiritideStandard of care until adequate diuresis achieved |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Decompensated heart failure hospitalization with at least 1 symptom and 1 sign of elevated filling pressures
- Admission estimated creatinine clearance =< 50 cc/min.
Key exclusion criteria (8 listed)
- Systolic blood pressure < 85 mm Hg
- Cardiogenic shock
- Volume depletion
- Myocardial infarction, unstable angina within last 30 days
- Significant valvular stenosis, hypertrophic/restrictive cardiomyopathy, or constrictive pericarditis
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 |
|---|---|---|
| NesiritideAlso: NatrecorNesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved. | Drug | Nesiritide + standard of care, Standard of care |
Primary outcome
Renal function
Time frame: within 7 days after randomization
5 secondary outcomes
Weight loss
Time frame: Within 7 days from randomization
Days to optimal volume status
Time frame: From randomization till day 7 or sooner
Concomitant diuretic use
Time frame: Within 7 days from randomization
Global symptom assessment
Time frame: 24 hrs and 3 days after randomization
Length of stay
Time frame: From admission to discharge or day 7
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 12 Sep 2013.
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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.
Anju Nohria, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nesiritide in people with Congestive Heart Failure and Renal Insufficiency, run by Brigham and Women's Hospital at 1 site in United States.
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 8 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 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Renal function (time frame: within 7 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2013.