Heart DecompensationPhase 3NCT00813202
An Open-label, One-arm, Study to Evaluate the Hemodynamic Changes and Safety of Nesiritide for Acute Decompensated Heart Failure
A Phase 3 study testing Nesiritide in people with Heart Decompensation and Congestive Heart Failure, run by Xian-Janssen Pharmaceutical Ltd. at 4 sites in China.
Trial summary
The present study was an open-label, uncontrolled, and multi-centered phase III clinical trial for evaluation of the efficacy (clinical efficacy and hemodynamics) and safety of nesiritide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Decompensation, Congestive Heart Failure
- 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
- 41 participants
- Where
- 4 sitesChina
- Study dates
- Oct 2006to Jun 2007
- 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
- Systolic blood pressure> 90 mmHg
- The subjects must present with dyspnoea at resting state or with minimum activity amount (such as standing up)
- Onset at this time was complicated with symptoms of acute decompensate heart failure, and it was serious enough to call for hospitalization and treatment with intravenous drug administration
- Acute decompensate heart failure was caused by cardiogenic factors rather than pulmonary factors (for example, it was neither cor pulmonale nor chronic heart failure complicated with pneumonia)
- The patients must have at least two of manifestations that related with this acute onset.
Who cannot join
- Patients with systolic blood pressure =90 mmHg
- patients who had been administered with intravenous nitroglycerin or other intravenous vasoactive drugs within 2 hour before administration of the investigational drug
- Patients who had known or suspected acute coronary syndrome (Myocardial infarction with or without increased ST segment, or unstable myocardial infarction) within 2 weeks before administration of the investigational drug
- Patients with cardiac shock or clinical manifestation of uncorrected hypovolemia or sodium depletion (such as clinical signs of excessive diuresis or dehydration), or clinical manifestation induced by other forbidden venous vasoactive agents
- Patients with such extremely emergent and unstable clinical conditions that not tolerant to Swan-Ganz catheter or temporal baseline evaluation
- patients with obvious cardiac valvular stenosis (subjects treated by valve-replacement can be included), hypertrophic, restrictive, or obstructive myocardial disease, primary pulmonary hypertension, or complex congenital heart disease.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Study site
Beijing
Study site
Hangzhou
Study site
Shanghai
Study site
Xi'an
About this study
Official title: An Open-label, Single Arm, Multi-centered Clinical Trial on the Hemodynamics and Safety of Nesiritide in the Treatment of Patients With Acute Decompensate Heart Failure
The present study was an open-label, uncontrolled, and multi-centered phase III clinical trial for evaluation of the efficacy (clinical efficacy and hemodynamics) and safety of nesiritide.
Read the detailed description
This was an open-label, uncontrolled, and multi-centered phase II clinical trial for evaluation of the clinical efficacy and hemodynamics and safety of nesiritide. The study was conducted in hospital setting and all patients exhibited symptoms of acute decompensated heart failure, requiring treatment with intravenous drug administration. The total duration was 180 days, including a screening phase, an open treatment phase (24 hours in all) and a safety follow-up phase (day 30 and day 180). Screening phase: Right heart floating catheter was placed for patients with acute decompensate heart failure who met the inclusion criteria while not the exclusion criteria to measure pulmonary capillary wedge pressure. The results should be =20 mmHg. Open treatment phase: Nesiritide was administered by intravenous injection at a dose of 2 µg/kg for 60 second, followed by intravenous infusion at a dose of 0.01 µg/kg for 24 hour. All the patients were monitored for hemodynamics for 24 hour. Safety follow-up phase: On day 30, all the patients were required to return to the study center for follow-up. Information about death, severe adverse event, re-hospitalization and serum creatinine was collected. On day 180, all the patients were followed up by telephone. Information about death and severe adverse event was collected. Pulmonary capillary wedge pressure will be measured at 15 minutes, 1 hour, 3 hour and 24 hour, compared with baseline value. Nesiritide is white to off-white sterile lyophilized lump or powder, supplied in transparent 5 mL glass vials. The investigational drug was administered via infusion pump. Infusion rate was adjusted according to body weight. The drug was administered directly via venous cannula or the nearest injection port to the venous cannula for 60 second. The dosage of nesiritide was 2 µg/kg. The infusion rate of nesiritide was adjusted to 0.01 µg/kg/min (cannot exceed 0.01 µg/kg/min).
- Conditions
- Heart Decompensation, Congestive Heart Failure
- Being tested
- Nesiritide
- Keywords
- Nesiritide, Natrecor, Quanke, Acute Decompensated Heart Failure
- 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
Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)
| Study group | Role | What they receive |
|---|---|---|
| Nesiritide | Experimental | Not described Receives: Drug: Nesiritide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary capillary wedge pressure
Pulmonary capillary wedge pressure will be measured in patients at all time points after administration of nesiritide, and the difference will be compared with baseline value (P<0.001).
Measured: Baseline, 180 days
Secondary outcomes (1)
Change in clinical symptoms and overall clinical efficacy
Nesiritide will attenuate dyspnoea. Nesiritide will also improve clinical symptoms and Nesiritide will improve overall clinical efficacy.
Measured: Baseline, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startOct 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DecompensationStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xian-Janssen Pharmaceutical Ltd. Clinical Trial, Study director, Xian-Janssen Pharmaceutical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813202
- Sponsor's protocol ID
- CR007573
- Status last verified
- Feb 2014
- First submitted
- 18 Dec 2008
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Arm, Multi-centered Clinical Trial on the Hemodynamics and Safety of Nesiritide in the Treatment of Patients With Acute Decompensate Heart Failure
- ClinicalTrials.gov ID
- NCT00813202
- Acronym / sponsor ID
- CR007573
- Conditions
- Heart Decompensation, Congestive Heart Failure
- Keywords
- Nesiritide, Natrecor, Quanke, Acute Decompensated Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Dec 2008 (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 present study was an open-label, uncontrolled, and multi-centered phase III clinical trial for evaluation of the efficacy (clinical efficacy and hemodynamics) and safety of nesiritide.
Detailed description
This was an open-label, uncontrolled, and multi-centered phase II clinical trial for evaluation of the clinical efficacy and hemodynamics and safety of nesiritide. The study was conducted in hospital setting and all patients exhibited symptoms of acute decompensated heart failure, requiring treatment with intravenous drug administration. The total duration was 180 days, including a screening phase, an open treatment phase (24 hours in all) and a safety follow-up phase (day 30 and day 180). Screening phase: Right heart floating catheter was placed for patients with acute decompensate heart failure who met the inclusion criteria while not the exclusion criteria to measure pulmonary capillary wedge pressure. The results should be =20 mmHg. Open treatment phase: Nesiritide was administered by intravenous injection at a dose of 2 µg/kg for 60 second, followed by intravenous infusion at a dose of 0.01 µg/kg for 24 hour. All the patients were monitored for hemodynamics for 24 hour. Safety follow-up phase: On day 30, all the patients were required to return to the study center for follow-up. Information about death, severe adverse event, re-hospitalization and serum creatinine was collected. On day 180, all the patients were followed up by telephone. Information about death and severe adverse event was collected. Pulmonary capillary wedge pressure will be measured at 15 minutes, 1 hour, 3 hour and 24 hour, compared with baseline value. Nesiritide is white to off-white sterile lyophilized lump or powder, supplied in transparent 5 mL glass vials. The investigational drug was administered via infusion pump. Infusion rate was adjusted according to body weight. The drug was administered directly via venous cannula or the nearest injection port to the venous cannula for 60 second. The dosage of nesiritide was 2 µg/kg. The infusion rate of nesiritide was adjusted to 0.01 µg/kg/min (cannot exceed 0.01 µg/kg/min).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nesiritide | Experimental | Drug: Nesiritide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systolic blood pressure> 90 mmHg
- The subjects must present with dyspnoea at resting state or with minimum activity amount (such as standing up)
- Onset at this time was complicated with symptoms of acute decompensate heart failure, and it was serious enough to call for hospitalization and treatment with intravenous drug administration
- Acute decompensate heart failure was caused by cardiogenic factors rather than pulmonary factors (for example, it was neither cor pulmonale nor chronic heart failure complicated with pneumonia)
- The patients must have at least two of manifestations that related with this acute onset.
Key exclusion criteria (6 listed)
- Patients with systolic blood pressure =90 mmHg
- patients who had been administered with intravenous nitroglycerin or other intravenous vasoactive drugs within 2 hour before administration of the investigational drug
- Patients who had known or suspected acute coronary syndrome (Myocardial infarction with or without increased ST segment, or unstable myocardial infarction) within 2 weeks before administration of the investigational drug
- Patients with cardiac shock or clinical manifestation of uncorrected hypovolemia or sodium depletion (such as clinical signs of excessive diuresis or dehydration), or clinical manifestation induced by other forbidden venous vasoactive agents
- Patients with such extremely emergent and unstable clinical conditions that not tolerant to Swan-Ganz catheter or temporal baseline evaluation
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 |
|---|---|---|
| NesiritideNesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs) | Drug | Nesiritide |
Primary outcome
Change in pulmonary capillary wedge pressure
Time frame: Baseline, 180 days
Pulmonary capillary wedge pressure will be measured in patients at all time points after administration of nesiritide, and the difference will be compared with baseline value (P<0.001).
1 secondary outcome
Change in clinical symptoms and overall clinical efficacy
Time frame: Baseline, 180 days
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 28 Feb 2014.
- An Open-label, Single Arm, Multi-centered Clinical Trial on the Hemodynamics and Safety of Nesiritide in the Treatment of Patients with Acute Decompensate Heart FailureLink 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.
Xian-Janssen Pharmaceutical Ltd. Clinical Trial study director
Xian-Janssen Pharmaceutical Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nesiritide in people with Heart Decompensation and Congestive Heart Failure, run by Xian-Janssen Pharmaceutical Ltd. at 4 sites in China.
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 5 inclusion and 6 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 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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 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?
Change in pulmonary capillary wedge pressure (time frame: Baseline, 180 days). 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 28 Feb 2014.