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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00494117




Registration number
NCT00494117
Ethics application status
Date submitted
28/06/2007
Date registered
29/06/2007
Date last updated
27/07/2010

Titles & IDs
Public title
Investigation of Heart Failure Status Over Time Using Respiratory Parameters
Scientific title
Investigation of Heart Failure Status Over Time Using Respiratory Parameters
Secondary ID [1] 0 0
X07- 0052
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Congestive 0 0
Sleep Apnea Syndromes 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - ApneaLink

Treatment: Devices: ApneaLink
A two channel sleep screening device for the assessment of Sleep Disordered Breathing.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Moderate to severe Heart Failure (as determined by Echocardiogram or by treating
physician)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Malignant disease affecting gas exchange or respiratory parameters

- Medications compromising breathing with no adverse affects on heart failure

- Clinically significant (moderate to severe) asthma requiring therapy

- Chronic parenchymal lung disease (FEV1/FVC ratio = 65% or as determined by the
treating physician)

- Severe pulmonary hypertension

- Heart failure due to alcohol abuse or chemotherapy

- Narcotic abuse/intravenous drug use (including HIV+ and hepatitis C)

- Alcohol consumption > 80g/day

- Patients receiving home Oxygen

- Methicillin- resistant Staphylococcus aureus infection

- Narcolepsy

- Cataplexy

- Enrolled in any concurrent study, that may confound the results of this study.

- Inability or refusal to sign the Patient Consent Form

- Inability or refusal to adhere to protocol requirements

Study design
Purpose
Duration
Selection
Timing
Prospective
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 study is to investigate respiratory indicators for clinically important
changes in Heart Failure status over time.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00494117
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/ct2/show/NCT00494117