Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000096257
Ethics application status
Approved
Date submitted
6/01/2009
Date registered
11/02/2009
Date last updated
11/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the potential of nebulised frusemide to relieve dyspnoea in people with advanced heart failure
Scientific title
Assessment of the potential of nebulised frusemide to relieve dyspnoea in people with advanced heart failure
Secondary ID [1] 775 0
St Vincent's Hospital Reference number H06/074
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 4169 0
Condition category
Condition code
Cardiovascular 4378 4378 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose administration of nebulised frusemide 40 mg (in 4 ml of diluent) to patients with chronic heart failure undergoing clinically-indicated right heart catheterisation. Frusemide/matching placebo is delivered as a single dose via a nebuliser immediately during right heart catheterisation immediately after completion of baseline haemodynamic measurements
Intervention code [1] 3887 0
Treatment: Drugs
Comparator / control treatment
Placebo consists of 4 ml Normal Saline also delivered as a single dose via a nebulised solution
Control group
Placebo

Outcomes
Primary outcome [1] 5255 0
Acute haemodynamic changes over one hour post drug administration. The primary endpoint is the change in pulmonary artery wedge pressure (mmHG) measured directly with a Swan-Ganz catheter over one hour after administration of study drug.
Timepoint [1] 5255 0
Baseline (before study drug administration), then 15, 30, 45, 60 minutes after study drug administration
Secondary outcome [1] 8855 0
Dyspnoea Score - assessed by visual analogue scale (0-10)
Timepoint [1] 8855 0
Baseline (before study drug administration), then 15, 30, 45, 60 minutes after study drug administration

Eligibility
Key inclusion criteria
Chronic stable heart failure
New York Heart Association Class 2-3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute decompensated heart failure
NYHA Class 1 or 4
Inability to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation undertaken by Clinical Trials Pharmacist at St Vincent's Hospital, who dispensed trial medication as unmarked solution for administration. All investigators and patients remained blinded to treatment (active versus placebo).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4345 0
Self funded/Unfunded
Name [1] 4345 0
Country [1] 4345 0
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Victoria St
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 3914 0
None
Name [1] 3914 0
Address [1] 3914 0
Country [1] 3914 0
Other collaborator category [1] 523 0
Individual
Name [1] 523 0
Patricia Davidson
Address [1] 523 0
Centre for Cardiovascular And Chronic Care
Curtin University of Technology
38 Regent St, Chippendale
Sydney, NSW, 2008
Country [1] 523 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6402 0
St Vincent's Hospital
Ethics committee address [1] 6402 0
390 Victoria St
Darlinghurst
NSW 2010
Ethics committee country [1] 6402 0
Australia
Date submitted for ethics approval [1] 6402 0
Approval date [1] 6402 0
28/08/2006
Ethics approval number [1] 6402 0
H06/074

Summary
Brief summary
Dyspnea is a burdensome symptom for individuals with heart failure (HF) and is responsible for high rates of hospitalization. Observational data, predominately in respiratory and cancer patients, suggest that nebulised furosemide may be useful for the symptomatic management of dyspnea. This evidence to date remains inconclusive and there have been no reports of the use of inhaled frusemide in HF. The aim of this study is to assess the impact of nebulised frusemide on the haemodynamic measures of heart function and on the symptom of dyspnoea in a population of patients with stable chronic heart failure
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35070 0
Address 35070 0
Country 35070 0
Phone 35070 0
Fax 35070 0
Email 35070 0
Contact person for public queries
Name 12417 0
Phillip Newton
Address 12417 0
Centre for Cardiovascular And Chronic Care
Curtin University of Technology
38 Regent St, Chippendale
Sydney, NSW, 2008
Country 12417 0
Australia
Phone 12417 0
+61 2 8399 7832
Fax 12417 0
+61 2 8399 7834
Email 12417 0
p.newton@curtin.edu.au
Contact person for scientific queries
Name 3345 0
Phillip Newton
Address 3345 0
Centre for Cardiovascular And Chronic Care
Curtin University of Technology
38 Regent St, Chippendale
Sydney, NSW, 2008
Country 3345 0
Australia
Phone 3345 0
+61 2 8399 7832
Fax 3345 0
+61 2 8399 7834
Email 3345 0
p.newton@curtin.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.