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| ID | Type | Description | Link |
|---|---|---|---|
| Project No. 11/06 |
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Recruitment very difficult. Study drug expired so we have stopped the study.
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| Name | Class |
|---|---|
| Janssen-Cilag Pty Ltd | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Nesiritide |
|
| B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nesiritide | Drug | Nesiritide 4 hour infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP | 24 hours |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Krum, MBBS FRACP PhD | Monash University / Alfred Hospital | Principal Investigator |
| Peter Cameron | Monash University / Alfred Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020097 | Natriuretic Peptide, Brain |
| ID | Term |
|---|---|
| D045265 | Natriuretic Peptides |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Drug |
Placebo infusion |
|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |