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Investigation of Heart Failure Status Over Time Using Respiratory Parameters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00494117
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : July 27, 2010
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Brief Summary:
The purpose of the study is to investigate respiratory indicators for clinically important changes in Heart Failure status over time.

Condition or disease Intervention/treatment
Heart Failure, Congestive Sleep Apnea Syndromes Device: ApneaLink

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Heart Failure Status Over Time Using Respiratory Parameters
Study Start Date : June 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population under investigation is moderate to severe heart failure who are outpatients of a major Sydney hospital.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00494117

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Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Sponsors and Collaborators
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Study Director: Rachel A Coxon, BE/MBiomedE ResMed/The University of New South Wales
Study Director: Klaus Schindhelm, PhD ResMed/The University of New South Wales
Study Director: Jodie Lattimore, PhD Royal Prince Alfred Hospital, Sydney, Australia
Principal Investigator: Ian Wilcox, PhD Royal Prince Alfred Hospital/The University of Sydney
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Responsible Party: Rachel Coxon, ResMed Identifier: NCT00494117    
Other Study ID Numbers: X07- 0052
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases