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

This study has been terminated.
(Recruitment very difficult. Study drug expired so we have stopped the study.)
Sponsor:
Collaborator:
Janssen-Cilag Pty Ltd
Information provided by:
The Alfred
ClinicalTrials.gov Identifier:
NCT00562692
First received: November 21, 2007
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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.

Condition Intervention Phase
Heart Failure
Drug: Nesiritide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Nesiritide
Drug: Nesiritide
Nesiritide 4 hour infusion
Placebo Comparator: B
Placebo
Drug: Placebo
Placebo infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562692

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
Janssen-Cilag Pty Ltd
Investigators
Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University / Alfred Hospital
Principal Investigator: Peter Cameron Monash University / Alfred Hospital
  More Information

No publications provided

Responsible Party: Prof Henry Krum, Alfred Hospital
ClinicalTrials.gov Identifier: NCT00562692     History of Changes
Other Study ID Numbers: CP-02/05, Project No. 11/06
Study First Received: November 21, 2007
Last Updated: August 3, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The Alfred:
Heart failure
OAD
BNP
Heart Failure patients who present to the emergency department

Additional relevant MeSH terms:
Heart Failure
Lung Diseases, Obstructive
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014