Heart FailurePhase 2NCT00145873
Nesiritide in Chronic Heart Failure
A Phase 2 study testing nesiritide, continuous infusion in people with Heart Failure, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- nesiritide, continuous infusion
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Sep 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
- Candidates for enrollment in this clinical trial are limited to adult patients (age>21) diagnosed with chronic heart failure > one year who are managed by heart failure specialists at the University of Chicago. Patients primarily managed by physicians other than the investigators will be enrolled with the concurrence of the treating physician. Study patients are characterized as "high risk" by fulfilling one or more of the following criteria:
- Refractory class III or IV heart failure despite optimal medical therapy by a heart failure specialist: Angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), beta-adrenergic blockers (BB), spironolactone (spiro), digoxin (dig), diuretics, and calcium channel blockers (CCB).
- Frequent hospitalizations or ER visits (>1/month on average).
- Additionally, patients must be capable of giving informed consent and have adequate social supports to manage chronic, continuous IV infusion therapy with the assistance of home care nursing and the study coordinator.
Who cannot join
- Nesiritide infusion >24 hours in the previous 30 days.
- Stable chronic heart failure or NYHA Class I or II.
- Aortic stenosis greater than mild degree as determined by echocardiogram or catheterization.
- Hypertrophic cardiomyopathy with an outflow tract gradient.
- Isolated right heart failure (cor pulmonale).
- Unstable coronary syndrome or myocardial infarction< 3 months prior to enrollment.
Show all 12Show fewer
- Chronic hypotension with systolic blood pressure < 80 mmHg.
- Terminal noncardiovascular illness with life expectancy <6 months. Moribund patients will not be considered for enrollment.
- Active substance abuse.
- Inadequate social support.
- Contraindication to long term IV access.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Hospitals
Chicago, Illinois, 60637
About this study
Official title: Continuous Infusion Nesiritide in Chronic Heart Failure-University of Chicago (CINCH-UC)
The purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure.
Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient setting, is a safe treatment for refractory Class III \& IV chronic heart failure due to systolic or diastolic dysfunction, regardless of renal function when administered over a 12-week period.
Read more
Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure. These mechanisms include reducing hospitalizations when compared with the previous six months, improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire, and improving functional capacity as measured by 6-minute walk testing.
Corollary #2: Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions.
Read the detailed description
This is a single center, double-blinded, crossover, placebo-controlled pilot study to evaluate the effects of nesiritide in patients with chronic heart failure. This study will only take place at the University of Chicago Hospitals. It is double-blinded, which means that the neither subject nor their study doctor will know which study drug the subject will receive. However, in an emergency, this information can be obtained quickly. The study is placebo-controlled, which means subjects will not receive study drug at some point during the study; however because it is a cross-over study, subjects will be receiving nesiritide at some point in the study. Subjects will receive the study drug nesiritide for six out of the 12 weeks of the study-either the first six weeks or the last six weeks.
The procedures for the study consist of: informed consent, questions about the subjects heart failure, blood sample, assessment of heart failure severity based on symptoms, six minute walk test and the Minnesota Living with Heart Failure Questionnaire, history of heart failure symptoms and emergency room visits, diuretic and baseline medication history, long term IV for medication infusions, adjustment of study drug and regularly taken medications, 6 weeks of receiving long term IV infusion of drug, blood taken for lab tests at each clinic visit and an informational card provided for subjects to use for on-call physicians.
Up to ten consecutive patients who decline participation in the study will be asked to participate in a registry to follow their course over the study interval. Baseline data, obtained from medical records will be recorded as will the number of hospitalizations/ER visits and NYHA class during the study period. These subjects will be surveyed by telephone monthly for the duration of the study.
- Conditions
- Heart Failure
- Being tested
- nesiritide, continuous infusion
- Keywords
- heart failure, nesiritide, heart disease, cardiovascular disease
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nesiritide, continuous infusionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NYHA status
Measured: Day 0, Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionSep 2006
- Study completionSep 2006
Why it stopped: Unable to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Scios, Inc.
- Responsible party
- Sponsor
- Investigators
- Allen Anderson, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145873
- Sponsor's protocol ID
- 12350A
- Other IDs
- 1
- Status last verified
- Sep 2006
- First submitted
- 1 Sep 2005
- Last updated
- 8 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion Nesiritide in Chronic Heart Failure-University of Chicago (CINCH-UC)
- ClinicalTrials.gov ID
- NCT00145873
- Acronym / sponsor ID
- 12350A
- Conditions
- Heart Failure
- Keywords
- heart failure, nesiritide, heart disease, cardiovascular disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to complete study
- Enrolment
- 20 participants
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Scios, Inc.
- Study start
- Aug 2003
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 5 Sep 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 purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure.
Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient setting, is a safe treatment for refractory Class III \& IV chronic heart failure due to systolic or diastolic dysfunction, regardless of renal function when administered over a 12-week period.
Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure. These mechanisms include reducing hospitalizations when compared with the previous six months, improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire, and improving functional capacity as measured by 6-minute walk testing.
Corollary #2: Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions.
Detailed description
This is a single center, double-blinded, crossover, placebo-controlled pilot study to evaluate the effects of nesiritide in patients with chronic heart failure. This study will only take place at the University of Chicago Hospitals. It is double-blinded, which means that the neither subject nor their study doctor will know which study drug the subject will receive. However, in an emergency, this information can be obtained quickly. The study is placebo-controlled, which means subjects will not receive study drug at some point during the study; however because it is a cross-over study, subjects will be receiving nesiritide at some point in the study. Subjects will receive the study drug nesiritide for six out of the 12 weeks of the study-either the first six weeks or the last six weeks.
The procedures for the study consist of: informed consent, questions about the subjects heart failure, blood sample, assessment of heart failure severity based on symptoms, six minute walk test and the Minnesota Living with Heart Failure Questionnaire, history of heart failure symptoms and emergency room visits, diuretic and baseline medication history, long term IV for medication infusions, adjustment of study drug and regularly taken medications, 6 weeks of receiving long term IV infusion of drug, blood taken for lab tests at each clinic visit and an informational card provided for subjects to use for on-call physicians.
Up to ten consecutive patients who decline participation in the study will be asked to participate in a registry to follow their course over the study interval. Baseline data, obtained from medical records will be recorded as will the number of hospitalizations/ER visits and NYHA class during the study period. These subjects will be surveyed by telephone monthly for the duration of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 (4 listed)
- Candidates for enrollment in this clinical trial are limited to adult patients (age>21) diagnosed with chronic heart failure > one year who are managed by heart failure specialists at the University of Chicago. Patients primarily managed by physicians other than the investigators will be enrolled with the concurrence of the treating physician. Study patients are characterized as "high risk" by fulfilling one or more of the following criteria:
- Refractory class III or IV heart failure despite optimal medical therapy by a heart failure specialist: Angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), beta-adrenergic blockers (BB), spironolactone (spiro), digoxin (dig), diuretics, and calcium channel blockers (CCB).
- Frequent hospitalizations or ER visits (>1/month on average).
- Additionally, patients must be capable of giving informed consent and have adequate social supports to manage chronic, continuous IV infusion therapy with the assistance of home care nursing and the study coordinator.
Key exclusion criteria (12 listed)
- Nesiritide infusion >24 hours in the previous 30 days.
- Stable chronic heart failure or NYHA Class I or II.
- Aortic stenosis greater than mild degree as determined by echocardiogram or catheterization.
- Hypertrophic cardiomyopathy with an outflow tract gradient.
- Isolated right heart failure (cor pulmonale).
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, continuous infusion | Drug | – |
Primary outcome
Change in NYHA status
Time frame: Day 0, Day 42
Results and safety
The study was stopped early (reason given: Unable to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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.
Allen Anderson, MD principal investigator
University of Chicago
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, continuous infusion in people with Heart Failure, run by University of Chicago 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 8 Oct 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 was stopped early (reason given: Unable to complete study). Results are not available in the source record.
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?
Change in NYHA status (time frame: Day 0, Day 42). 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 8 Oct 2013.