Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease

Heart Failure Clinical Trial

— BNP in OAD  

Official title:

Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease

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

• Heart Failure
• Lung Diseases, Obstructive

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