Heart Failure, CongestivePhase 2NCT00091520
A Study of the Safety and Efficacy of Follow-up Serial Infusions of Natrecor(Nesiritide) for the Management of Patients With Heart Failure
A Phase 2 study testing Nesiritide in people with Heart Failure, Congestive, run by Scios, Inc..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Nesiritide administered as serial infusions to heart failure (HF) patients in the outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Nesiritide
- How many people
- 920 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Dec 2006
- 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
- Had at least two qualifying hospitalizations or hospitalization equivalents in the past year, with the most recent hospitalization or hospitalization equivalent within the past 60 days, but who has been out of the hospital at least 5 days (the day of discharge is day 0)
- Have documentation indicating that the patient was consistently New York Heart Association (NYHA) Class III or IV during the 60 days before randomization
- Have a Left Ventricular Ejection Fraction less than 40% (measured within 24 weeks before randomization)
- Are (1)NYHA Class IV or (2)NYHA Class III with highest calculated CrCl, 60mL/min within the previous 30 days
- Are receiving optimal treatment with long-term oral medications (e.g., diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and beta blockers, unless these are documented to be contraindicated or not tolerated)
- Agree to come to the clinic up to 2 times per week (according to randomization) for 16 weeks of study drug infusions and to participate in all required follow-up assessments through week 24. In addition, agree to be contacted monthly after week 24 for follow-up, until the entire study has been completed
Who cannot join
- Have systolic blood pressure consistently <90mm Hg
- Are unable or unwilling to discontinue intermittent or continuous infusions of dopamine, dobutamine, milrinone, nitroglycerin, or open-label Natrecor beginning at the time of the screening visit
- Have required recent outpatient IV vasoactive (milrinone, dobutamine, dopamine, nitroglycerin, or open-label Natrecor) therapy as defined as >2 outpatient (excluding emergency room or inpatient) infusions in the last 30 days without a subsequent hospitalization
- Had, or during the course of the study are anticipated to have, any organ transplantation (heart, liver, lung, kidney, or bone marrow)
- Had a biventricular pacemaker placed within the 45 days before randomization or a single or dual chamber pacemaker or an automatic implantable cardiac defibrillator placed within the 15 days before randomization
- Have cardiogenic shock, volume depletion, or any other clinical condition at the time of randomization that would contraindicate the administration of Natrecor
- Are currently receiving chronic dialysis or have the expectation that dialysis will be required during the next 12 months.
About this study
Official title: Follow-up Serial Infusions of Natrecor(Nesiritide) in the Management of Patients With Heart Failure-FUSION II
The purpose of this study is to evaluate the efficacy and safety of Nesiritide administered as serial infusions to heart failure (HF) patients in the outpatient setting.
Read the detailed description
Heart Failure (HF) is the inability of the heart to pump efficiently and the heart cannot perform the necessary circulation of blood through the body. This can result in symptoms like shortness of breath at rest or with minimal activity. Advanced heart failure is one of the leading causes of hospitalization and deaths in the United States. This is a prospective randomized, double-blind, placebo-controlled parallel group, multicenter study of the effectiveness of Nesiritide administered as serial infusions in the outpatient setting. Patients enrolled in this study will receive nesiritide or placebo for up to 12 weeks. Patients will then be followed for an additional 12 weeks. During the the first 17 weeks of the study patients will have multiple laboratory tests, have their vital signs (blood pressure and heart rate) assessed, and complete quality of life questionnaires. During the last few weeks of the study patients will be contacted to inquire how they are doing. The study hypothesis is that compared to placebo plus standard care, Nesiritide plus standard will reduce time to death or first occurrence of hospitalization due to heart or kidney problems. Safety will be assessed through the collection of adverse events, clinical laboratory tests and vital signs at various time points throughout the study. The patients assigned to the nesiritide group will receive a single 2.0mcg/kg bolus (one time injection) followed by serial IV infusions (4 to 6 hours) at a standard flow rate of 0.010 mcg/kg/min once or twice per week for 12 weeks. The patients assigned to the placebo group will receive matching placebo.
- Conditions
- Heart Failure, Congestive
- Being tested
- Nesiritide
- Keywords
- Congestive heart failure, Nesiritide
- Medical subject headings
- Heart Failure
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.
Time to all-cause death or first occurrence of hospitalization for cardiovascular and/or renal causes from the day of randomization through week 12.
Secondary outcomes (1)
Number of cardiovascular and/or renal hospital admissions adjusted for duration of observation period through the end of week 12. Days alive and out of the hospital from the day of randomization through the end of week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2004 (estimated)
- Study startApr 2004
- Study completionDec 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 920 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
- NCT00091520
- Sponsor's protocol ID
- CR003355
- Status last verified
- Mar 2010
- First submitted
- 9 Sep 2004
- Last updated
- 20 May 2011
- Results posted
- No
Publications
Yancy CW, Krum H, Massie BM, Silver MA, Stevenson LW, Cheng M, Kim SS, Evans R; FUSION II Investigators. Safety and efficacy of outpatient nesiritide in patients with advanced heart failure: results of the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial. Circ Heart Fail. 2008 May;1(1):9-16. doi: 10.1161/CIRCHEARTFAILURE.108.767483.
PubMed 19808265
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Serial Infusions of Natrecor(Nesiritide) in the Management of Patients With Heart Failure-FUSION II
- ClinicalTrials.gov ID
- NCT00091520
- Acronym / sponsor ID
- CR003355
- Conditions
- Heart Failure, Congestive
- Keywords
- Congestive heart failure, Nesiritide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- Scios, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Oct 2004 (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 study is to evaluate the efficacy and safety of Nesiritide administered as serial infusions to heart failure (HF) patients in the outpatient setting.
Detailed description
Heart Failure (HF) is the inability of the heart to pump efficiently and the heart cannot perform the necessary circulation of blood through the body. This can result in symptoms like shortness of breath at rest or with minimal activity. Advanced heart failure is one of the leading causes of hospitalization and deaths in the United States. This is a prospective randomized, double-blind, placebo-controlled parallel group, multicenter study of the effectiveness of Nesiritide administered as serial infusions in the outpatient setting. Patients enrolled in this study will receive nesiritide or placebo for up to 12 weeks. Patients will then be followed for an additional 12 weeks. During the the first 17 weeks of the study patients will have multiple laboratory tests, have their vital signs (blood pressure and heart rate) assessed, and complete quality of life questionnaires. During the last few weeks of the study patients will be contacted to inquire how they are doing. The study hypothesis is that compared to placebo plus standard care, Nesiritide plus standard will reduce time to death or first occurrence of hospitalization due to heart or kidney problems. Safety will be assessed through the collection of adverse events, clinical laboratory tests and vital signs at various time points throughout the study. The patients assigned to the nesiritide group will receive a single 2.0mcg/kg bolus (one time injection) followed by serial IV infusions (4 to 6 hours) at a standard flow rate of 0.010 mcg/kg/min once or twice per week for 12 weeks. The patients assigned to the placebo group will receive matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Had at least two qualifying hospitalizations or hospitalization equivalents in the past year, with the most recent hospitalization or hospitalization equivalent within the past 60 days, but who has been out of the hospital at least 5 days (the day of discharge is day 0)
- Have documentation indicating that the patient was consistently New York Heart Association (NYHA) Class III or IV during the 60 days before randomization
- Have a Left Ventricular Ejection Fraction less than 40% (measured within 24 weeks before randomization)
- Are (1)NYHA Class IV or (2)NYHA Class III with highest calculated CrCl, 60mL/min within the previous 30 days
- Are receiving optimal treatment with long-term oral medications (e.g., diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and beta blockers, unless these are documented to be contraindicated or not tolerated)
Key exclusion criteria (7 listed)
- Have systolic blood pressure consistently <90mm Hg
- Are unable or unwilling to discontinue intermittent or continuous infusions of dopamine, dobutamine, milrinone, nitroglycerin, or open-label Natrecor beginning at the time of the screening visit
- Have required recent outpatient IV vasoactive (milrinone, dobutamine, dopamine, nitroglycerin, or open-label Natrecor) therapy as defined as >2 outpatient (excluding emergency room or inpatient) infusions in the last 30 days without a subsequent hospitalization
- Had, or during the course of the study are anticipated to have, any organ transplantation (heart, liver, lung, kidney, or bone marrow)
- Had a biventricular pacemaker placed within the 45 days before randomization or a single or dual chamber pacemaker or an automatic implantable cardiac defibrillator placed within the 15 days before randomization
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
Time to all-cause death or first occurrence of hospitalization for cardiovascular and/or renal causes from the day of randomization through week 12.
1 secondary outcome
Number of cardiovascular and/or renal hospital admissions adjusted for duration of observation period through the end of week 12. Days alive and out of the hospital from the day of randomization through the end of week 12.
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 20 May 2011.
- Derived from this study: PubMed 19808265Yancy CW, Krum H, Massie BM, Silver MA, Stevenson LW, Cheng M, Kim SS, Evans R; FUSION II Investigators. Safety and efficacy of outpatient nesiritide in patients with advanced heart failure: results of the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial. Circ Heart Fail. 2008 May;1(1):9-16. doi: 10.1161/CIRCHEARTFAILURE.108.767483.
- Follow-up Serial Infusions of Natrecor(Nesiritide) in the Management of Patients With Heart Failure-FUSION IILink provided by the sponsor.
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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 2 study testing Nesiritide in people with Heart Failure, Congestive, 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 6 inclusion and 7 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 20 May 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 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?
Time to all-cause death or first occurrence of hospitalization for cardiovascular and/or renal causes from the day of randomization through week 12.. 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 NCT00091520, 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 20 May 2011.