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

NCT00562692 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-06-25

No results posted yet for this study

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

Interventions

DRUG

Nesiritide

Nesiritide 4 hour infusion

DRUG

Placebo

Placebo infusion

Sponsors & Collaborators

  • Janssen-Cilag Pty Ltd

    collaborator INDUSTRY

  • The Alfred

    lead OTHER

Principal Investigators

  • Henry Krum, MBBS FRACP PhD · Monash University / Alfred Hospital

  • Peter Cameron · Monash University / Alfred Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-07-31
Completion
2009-09-30

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00562692 on ClinicalTrials.gov