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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00562692




Registration number
NCT00562692
Ethics application status
Date submitted
21/11/2007
Date registered
22/11/2007
Date last updated
25/06/2015

Titles & IDs
Public title
Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease
Scientific title
Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease
Secondary ID [1] 0 0
Project No. 11/06
Secondary ID [2] 0 0
CP-02/05
Universal Trial Number (UTN)
Trial acronym
BNP in OAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nesiritide
Treatment: Drugs - Placebo

Experimental: A - Nesiritide

Placebo Comparator: B - Placebo


Treatment: Drugs: Nesiritide
Nesiritide 4 hour infusion

Treatment: Drugs: Placebo
Placebo infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo.
Timepoint [1] 0 0
24 hours
Secondary outcome [1] 0 0
dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP
Timepoint [1] 0 0
24 hours

Eligibility
Key inclusion criteria
1. Males and females

2. Over 18 years of age

3. Confirmed written informed consent.

4. Acute decompensated heart failure based on physicians assessment and requiring
treatment as per standard emergency department protocols for this condition.

5. Requirement for intravenous therapy of HF, e.g. diuretic, vasodilator.

6. 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:

- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women lactating, pregnant or of childbearing potential not using 2 reliable
contraceptive methods.

2. Patients who had received an investigational new drug within the last 4 weeks.

3. 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.

4. SBP <90mmHg

5. Creatinine >0.25mmol/L

6. Sp02 < 80% on supplemental oxygen or known cor pulmonale with TR

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen-Cilag Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00562692
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, MBBS FRACP PhD
Address 0 0
Monash University / Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00562692