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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Nesiritide
Placebo
Sponsored by
The Alfred
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, OAD, BNP, Heart Failure patients who present to the emergency department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alfred Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Nesiritide

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP

Full Information

First Posted
November 21, 2007
Last Updated
June 23, 2015
Sponsor
The Alfred
Collaborators
Janssen-Cilag Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00562692
Brief Title
Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease
Acronym
BNP in OAD
Official Title
Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Recruitment very difficult. Study drug expired so we have stopped the study.
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Alfred
Collaborators
Janssen-Cilag Pty Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, OAD, BNP, Heart Failure patients who present to the emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Nesiritide
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Nesiritide
Intervention Description
Nesiritide 4 hour infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo infusion
Primary Outcome Measure Information:
Title
To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females Over 18 years of age Confirmed written informed consent. Acute decompensated heart failure based on physicians assessment and requiring treatment as per standard emergency department protocols for this condition. Requirement for intravenous therapy of HF, e.g. diuretic, vasodilator. 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: Women lactating, pregnant or of childbearing potential not using 2 reliable contraceptive methods. Patients who had received an investigational new drug within the last 4 weeks. 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. SBP <90mmHg Creatinine >0.25mmol/L Sp02 < 80% on supplemental oxygen or known cor pulmonale with TR
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Krum, MBBS FRACP PhD
Organizational Affiliation
Monash University / Alfred Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Cameron
Organizational Affiliation
Monash University / Alfred Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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