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Investigation of Heart Failure Status Over Time Using Respiratory Parameters

This study has been completed.
Sponsor:
Information provided by:
ResMed
ClinicalTrials.gov Identifier:
NCT00494117
First received: June 28, 2007
Last updated: July 25, 2010
Last verified: July 2010
History of Changes
  Purpose

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


Condition Intervention
Heart Failure, Congestive
Sleep Apnea Syndromes
 Device: ApneaLink

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Heart Failure Status Over Time Using Respiratory Parameters

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ResMed:

Enrollment: 50
Study Start Date: June 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ApneaLink
    A two channel sleep screening device for the assessment of Sleep Disordered Breathing.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494117

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Sponsors and Collaborators
ResMed
Investigators
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
  More Information

No publications provided

Responsible Party: Rachel Coxon, ResMed
ClinicalTrials.gov Identifier: NCT00494117     History of Changes
Other Study ID Numbers: X07- 0052
Study First Received: June 28, 2007
Last Updated: July 25, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Heart Failure
Sleep Apnea Syndromes
Heart Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
 Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013