Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00495196




Registration number
NCT00495196
Ethics application status
Date submitted
28/06/2007
Date registered
2/07/2007
Date last updated
27/07/2010

Titles & IDs
Public title
Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration
Scientific title
Cardiovascular Response to Peripheral Chemoreceptor Stimulation in Congestive Heart Failure With Cheyne- Stokes Respiration
Secondary ID [1] 0 0
X07-0079
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Congestive 0 0
Cheyne-Stokes Respiration 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Experimental lung function test

Experimental: 1 -

Active comparator: 2 -


Treatment: Surgery: Experimental lung function test
Administration of several CO2 gas mixtures
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cardiovascular parameters such as continuous blood pressure and heart rate.
Timepoint [1] 0 0
During administration of the intervention

Eligibility
Key inclusion criteria
* Moderate to severe heart failure (NYHA Class II or above) on optimal medical therapy
* LVEF less than or equal to 45%
* Stable condition as defined as no hospital admission or changes to medical therapy within two weeks prior to enrolment
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Patients taking known respiratory stimulants or depressants
* Clinically significant asthma requiring therapy
* Significant parenchymal lung disease
* Primary pulmonary hypertension
* Myocardial infarction within three months prior to enrolment
* Patients with cardiac resynchronisation devices and permanent pacemakers
* Anaemic (haemoglobin < 12g/dL)

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the trial is to investigate the cardiovascular response to peripheral chemoreceptor stimulation in Congestive Heart Failure with Cheyne- Stokes Respiration
Trial website
https://clinicaltrials.gov/study/NCT00495196
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rachel A Coxon, BE/MBiomedE
Address 0 0
ResMed/The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00495196