Heart FailurePhase 3BNP in OADNCT00562692
Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease
A Phase 3 study testing Nesiritide in people with Heart Failure, run by The Alfred at 1 site in Australia.
Trial summary
Brain natriuretic peptide (BNP) is a useful therapy when treating patients with heart failure. As many of these patients also have airways disease it is important to determine if BNP also has a positive effect on their respiratory condition. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2007to Sep 2009
- 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
- Males and females
- Over 18 years of age
- Confirmed written informed consent.
- Acute decompensated heart failure based on physicians assessment and requiring treatment as per standard emergency department protocols for this condition.
- Requirement for intravenous therapy of HF, e.g. diuretic, vasodilator.
- COAD based on physician's assessment and requiring treatment as per standard emergency department protocols for this condition. Must have at least 2 of the following criteria:
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- history of smoking > 20 pack years,
- prior history of PFTs within last 1 year consistent with COAD,
- history of chronic cough and sputum production,
- progressive dyspnea, episodes of acute bronchitis over at least 2 yrs
Who cannot join
- Women lactating, pregnant or of childbearing potential not using 2 reliable contraceptive methods.
- Patients who had received an investigational new drug within the last 4 weeks.
- Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- SBP <90mmHg
- Creatinine >0.25mmol/L
- Sp02 < 80% on supplemental oxygen or known cor pulmonale with TR
Trial locations and contacts
1 site in 1 country.
About this study
Brain natriuretic peptide (BNP) is a useful therapy when treating patients with heart failure. As many of these patients also have airways disease it is important to determine if BNP also has a positive effect on their respiratory condition. The role of BNP in airways disease has never been studied although there is evidence to suggest that it will have a positive effect.
The current study is therefore a proof on concept study which will demonstrate whether BNP (nesiritide) will improve both heart failure and airflow obstruction in patient who have both.
Read more
The investigators are looking to enroll 40 patients with heart failure and airways disease who present to hospital emergency departments. Patients who consent and meet the entry criteria will be randomised to receive either nesiritide or placebo in addition to standard therapy. They will receive a bolus of study medication followed by a 4 hour infusion. Before, at hourly intervals and immediately following the infusion the following data will be collected:
- dyspnoea score
- respiratory rate
- FEV1 (if able to be performed)
- peak respiratory flow rates (PEFR, if able to be performed)
- requirement for concomitant bronchodilator therapy
- urinary GMP At all times during the study period and at the conclusion of the study patients will be provided with the best available therapy for their condition at the physicians' discretion.
- Conditions
- Heart Failure
- Being tested
- Nesiritide, Placebo
- Keywords
- Heart failure, OAD, BNP, Heart Failure patients who present to the emergency department
- 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 4 hour infusion
PlaceboDrug
Placebo infusion
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Nesiritide Receives: Drug: Nesiritide |
| B | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo.
Measured: 24 hours
Secondary outcomes (1)
dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP
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 posted22 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2009
- Study completionSep 2009
Why it stopped: Recruitment very difficult. Study drug expired so we have stopped the 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.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Pty Ltd
- Responsible party
- Principal investigator, Henry Krum, The Alfred
- Investigators
- Henry Krum, MBBS FRACP PhD, Principal investigator, Monash University / Alfred HospitalPeter Cameron, Principal investigator, Monash University / Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562692
- Sponsor's protocol ID
- CP-02/05
- Other IDs
- Project No. 11/06
- Acronym
- BNP in OAD
- Status last verified
- Jun 2015
- First submitted
- 21 Nov 2007
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease
- ClinicalTrials.gov ID
- NCT00562692
- Acronym / sponsor ID
- BNP in OAD / CP-02/05
- Conditions
- Heart Failure
- Keywords
- Heart failure, OAD, BNP, Heart Failure patients who present to the emergency department
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment very difficult. Study drug expired so we have stopped the study.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- Janssen-Cilag Pty Ltd
- Study start
- Sep 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Nov 2007 (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.
Brain natriuretic peptide (BNP) is a useful therapy when treating patients with heart failure. As many of these patients also have airways disease it is important to determine if BNP also has a positive effect on their respiratory condition. The role of BNP in airways disease has never been studied although there is evidence to suggest that it will have a positive effect.
The current study is therefore a proof on concept study which will demonstrate whether BNP (nesiritide) will improve both heart failure and airflow obstruction in patient who have both.
The investigators are looking to enroll 40 patients with heart failure and airways disease who present to hospital emergency departments. Patients who consent and meet the entry criteria will be randomised to receive either nesiritide or placebo in addition to standard therapy. They will receive a bolus of study medication followed by a 4 hour infusion. Before, at hourly intervals and immediately following the infusion the following data will be collected:
- dyspnoea score
- respiratory rate
- FEV1 (if able to be performed)
- peak respiratory flow rates (PEFR, if able to be performed)
- requirement for concomitant bronchodilator therapy
- urinary GMP At all times during the study period and at the conclusion of the study patients will be provided with the best available therapy for their condition at the physicians' discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: NesiritideNesiritide |
| B | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females
- Over 18 years of age
- Confirmed written informed consent.
- Acute decompensated heart failure based on physicians assessment and requiring treatment as per standard emergency department protocols for this condition.
- Requirement for intravenous therapy of HF, e.g. diuretic, vasodilator.
Key exclusion criteria (6 listed)
- Women lactating, pregnant or of childbearing potential not using 2 reliable contraceptive methods.
- Patients who had received an investigational new drug within the last 4 weeks.
- Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- SBP <90mmHg
- Creatinine >0.25mmol/L
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 4 hour infusion | Drug | A |
| PlaceboPlacebo infusion | Drug | B |
Primary outcome
To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo.
Time frame: 24 hours
1 secondary outcome
dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Recruitment very difficult. Study drug expired so we have stopped the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
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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.
Henry Krum, MBBS FRACP PhD principal investigator
Monash University / Alfred Hospital
Peter Cameron principal investigator
Monash University / Alfred Hospital
1 site 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 Failure, run by The Alfred at 1 site in Australia.
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 10 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: stopped early, as of the sponsor's last update on 25 Jun 2015. 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 Australia. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Recruitment very difficult. Study drug expired so we have stopped the 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?
To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo. (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 25 Jun 2015.