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

Phase 3

Terminated

• Conditions: Heart Failure
• Interventions: Drug: Nesiritide; Drug: Placebo

• Registration Number: NCT00562692
• Lead Sponsor: The Alfred

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-22
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Nesiritide	Nesiritide
B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo.	24 hours

Secondary Outcome Measures

Name	Time	Method
dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP	24 hours

Trial Locations

Locations (1)

Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia