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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00562692
Other study ID # CP-02/05
Secondary ID Project No. 11/0
Status Terminated
Phase Phase 3
First received November 21, 2007
Last updated June 23, 2015
Start date September 2007
Est. completion date September 2009

Study information

Verified date June 2015
Source The Alfred
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date September 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Nesiritide
Nesiritide 4 hour infusion
Placebo
Placebo infusion

Locations

Country Name City State
Australia Alfred Hospital Melbourne Victoria

Sponsors (2)

Lead Sponsor Collaborator
The Alfred Janssen-Cilag Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo. 24 hours No
Secondary dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP 24 hours No
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