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NCT00494117 Clinical Trial

Investigation of Heart Failure Status Over Time Using Respiratory Parameters

Heart Failure, Congestive Clinical Trial

Official title:
Investigation of Heart Failure Status Over Time Using Respiratory Parameters

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00494117
Other study ID # X07- 0052
Secondary ID
Status Completed
Phase N/A
First received June 28, 2007
Last updated July 25, 2010
Start date June 2007
Est. completion date March 2010

Study information
Verified date July 2010
Source ResMed
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Observational

Clinical Trial Summary

The purpose of the study is to investigate respiratory indicators for clinically important changes in Heart Failure status over time.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Moderate to severe Heart Failure (as determined by Echocardiogram or by treating physician)

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• ApneaLink
A two channel sleep screening device for the assessment of Sleep Disordered Breathing.

Locations
Country Name City State
Australia Royal Prince Alfred Hospital Camperdown New South Wales

Sponsors (1)
Lead Sponsor Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

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