Heart FailurePhase 2NCT00240084
Nesiritide and Vo2 Max in Heart Failure Patients
A Phase 2 study testing nesiritide (Natrecor(TM)) in people with Heart Failure, run by University of Rochester at 1 site in United States.
Trial summary
This research study, funded by Scios, Inc., and conducted by the Cardiology Division of the Department of Medicine at the University of Rochester School of Medicine and Dentistry investigates the potential benefit of nesiritide (brand name is Natrecor(TM))in improving exercise capacity in patients with heart failure… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- nesiritide (Natrecor(TM))
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 with NYHA Class II or III heart failure
- Referred to Strong Memorial Hospital for consideration of heart transplant
- Male or female and infertile or using effective contraception with negative pregnancy test
- Capable of IV access
- Able to perform a maximal bicycle test and tolerate mouthpiece and nose clip
- Fully understands and has signed Informed Consent Form before study begins
- Endogenous BNP level of at least 100 pg/mL
- Current smokers smoking < 3 cigarettes / day. Smoking is not permitted within the hospital, ergo subjects would not be permitted to smoke during study participation.
Who cannot join
- NYHA Class i or IV heart failure
- Creatinine clearance < 30 ml/min, as determined within 2 weeks of the start of the study
- EF > 40%
- Evidence of primary lung disease
- Hypersensitivity to nesiritide or any of its' components
- Current smokers as defined by > 3 cigarettes / day
Show all 10Show fewer
- Stroke within 3 months, myocardial infarction within 2 months, or any evidence of active myocardial ischemia
- Unwillingness ir inability to remain in the hospital overnight
- Clinical condition or laboratory abnormality which may increase risks associated with participation or interfere with result interpretation
- Any condition which would preclude heart transplantation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
This research study, funded by Scios, Inc., and conducted by the Cardiology Division of the Department of Medicine at the University of Rochester School of Medicine and Dentistry investigates the potential benefit of nesiritide (brand name is Natrecor(TM))in improving exercise capacity in patients with heart failure (HF). Previous studies have shown beneficial hemodynamic and neurohumoral effects of nesiritide infusion in the therapy of decompensated heart failure. Other studies have demonstrated increases in endogenous BNP levels (normalized for exercise workload) in HF patients during and after exercise. However, trials involving the measurement of exercise capacity in this population following BNP administration are lacking. This is an experimental prospective, non-blinded, pilot study with a sample size of 20 patients, all serving as their own controls. This study involves off-label use of the drug nesiritide (indicated for IV treatment of NYHA Class II and III patients, and this study is enrolling Class II and III patients) and has received FDA approval, and an IND. Subjects are recruited from the population of referrals to the Strong Memorial Hospital Heart Failure and Transplantation clinical service, who meet all the inclusion criteria and none of the exclusion criteria may participate in the study. Enrolled study subjects perform an exercise VO2 max test, receive a 24 hour infusion of nesiritide and perform a second exercise VO2 max test.
Read the detailed description
See above comments.
- Conditions
- Heart Failure
- Being tested
- nesiritide (Natrecor(TM))
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nesiritide (Natrecor(TM))Drug
administration of IV nesiritide
| Study group | Role | What they receive |
|---|---|---|
| Nesiritide infusion | Experimental | Single arm study. 24-hour infusion of B-type Natriuretic Peptide at a dose of 0.01 mcg/kg/minute. Receives: Drug: nesiritide (Natrecor(TM)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2
The goal of this study is to determine whether a continuous 24-hour infusion of B-type Natriuretic Peptide at a dose of 0.01 mcg/kg/minute will produce a significant improvement in exercise capacity as defined by maximum oxygen consumption (VO2 peak).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startJul 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 Heart FailureStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Scios, Inc.
- Responsible party
- Principal investigator, Leway Chen, University of Rochester
- Investigators
- Leway Chen, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240084
- Sponsor's protocol ID
- NES V02
- Status last verified
- Jun 2013
- First submitted
- 13 Oct 2005
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nesiritide and Vo2 Max in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00240084
- Acronym / sponsor ID
- NES V02
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Scios, Inc.
- Study start
- Jul 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 17 Oct 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.
This research study, funded by Scios, Inc., and conducted by the Cardiology Division of the Department of Medicine at the University of Rochester School of Medicine and Dentistry investigates the potential benefit of nesiritide (brand name is Natrecor(TM))in improving exercise capacity in patients with heart failure (HF). Previous studies have shown beneficial hemodynamic and neurohumoral effects of nesiritide infusion in the therapy of decompensated heart failure. Other studies have demonstrated increases in endogenous BNP levels (normalized for exercise workload) in HF patients during and after exercise. However, trials involving the measurement of exercise capacity in this population following BNP administration are lacking. This is an experimental prospective, non-blinded, pilot study with a sample size of 20 patients, all serving as their own controls. This study involves off-label use of the drug nesiritide (indicated for IV treatment of NYHA Class II and III patients, and this study is enrolling Class II and III patients) and has received FDA approval, and an IND. Subjects are recruited from the population of referrals to the Strong Memorial Hospital Heart Failure and Transplantation clinical service, who meet all the inclusion criteria and none of the exclusion criteria may participate in the study. Enrolled study subjects perform an exercise VO2 max test, receive a 24 hour infusion of nesiritide and perform a second exercise VO2 max test.
Detailed description
See above comments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nesiritide infusion | Experimental | Drug: nesiritide (Natrecor(TM))Single arm study. 24-hour infusion of B-type Natriuretic Peptide at a dose of 0.01 mcg/kg/minute. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-65 with NYHA Class II or III heart failure
- Referred to Strong Memorial Hospital for consideration of heart transplant
- Male or female and infertile or using effective contraception with negative pregnancy test
- Capable of IV access
- Able to perform a maximal bicycle test and tolerate mouthpiece and nose clip
Key exclusion criteria (10 listed)
- NYHA Class i or IV heart failure
- Creatinine clearance < 30 ml/min, as determined within 2 weeks of the start of the study
- EF > 40%
- Evidence of primary lung disease
- Hypersensitivity to nesiritide or any of its' components
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 (Natrecor(TM))administration of IV nesiritide | Drug | Nesiritide infusion |
Primary outcome
Peak VO2
Time frame: 24 hours
The goal of this study is to determine whether a continuous 24-hour infusion of B-type Natriuretic Peptide at a dose of 0.01 mcg/kg/minute will produce a significant improvement in exercise capacity as defined by maximum oxygen consumption (VO2 peak).
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 19 Jun 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.
Leway Chen, MD principal investigator
University of Rochester
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 (Natrecor(TM)) in people with Heart Failure, run by University of Rochester 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 8 inclusion and 10 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 19 Jun 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?
Peak VO2 (time frame: 24 hours). 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 19 Jun 2013.