Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT00562692
Status:
TERMINATED
Last Update Posted:
2015-06-25
First Post:
2007-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease
Sponsor:
The Alfred
Organization:
Study Overview
Official Title:
Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment very difficult. Study drug expired so we have stopped the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BNP in OAD
Brief 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. 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Project No. 11/06 | None | None | View |