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

NCT00562692 | Terminated Phase 3

• 2 other identifiers: CP-02/05Project No. 11/06
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Heart failure; OAD; BNP; Heart Failure patients who present to the emergency department

Outcome Measures

Primary Outcomes (1)

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

  24 hours

Secondary Outcomes (1)

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

  24 hours

Study Arms (2)

A

EXPERIMENTAL

Nesiritide

Drug: Nesiritide

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Nesiritide DRUG

Nesiritide 4 hour infusion

A

Placebo DRUG

Placebo infusion

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead
• Janssen-Cilag Pty Ltd: collaborator

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Henry Krum, MBBS FRACP PhD

  Monash University / Alfred Hospital

  PRINCIPAL INVESTIGATOR

• Peter Cameron

  Monash University / Alfred Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Clinical Pharmacology

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 22, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

AU (1)