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

NCT ID: NCT00562692

Last Updated: 2015-06-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-09-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Nesiritide

Group Type: EXPERIMENTAL

Nesiritide

Intervention Type: DRUG

Nesiritide 4 hour infusion

B

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo infusion

Interventions

Nesiritide

Nesiritide 4 hour infusion

Intervention Type: DRUG

Placebo

Placebo infusion

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Pty Ltd

INDUSTRY

Sponsor Role: collaborator

The Alfred

OTHER

Sponsor Role: lead

Responsible Party

Henry Krum

Head Clinical Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry Krum, MBBS FRACP PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University / Alfred Hospital

Peter Cameron

Role: PRINCIPAL_INVESTIGATOR

Monash University / Alfred Hospital

Locations

Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

Project No. 11/06

Identifier Type: -

Identifier Source: secondary_id

CP-02/05

Identifier Type: -

Identifier Source: org_study_id