Investigation of Heart Failure Status Over Time Using Respiratory Parameters - Full Text View

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

MedlinePlus related topics:

Heart Failure Sleep Apnea

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by ResMed:

Estimated Enrollment:	50
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2008

Intervention Details:

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

Contacts


Contact: Rachel A Coxon, BE/MBiomedE	+64 02 88842328	rachelc@resmed.com.au

Locations


Australia, New South Wales
	Royal Prince Alfred Hospital	Recruiting
	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

Responsible Party:	ResMed ( Rachel Coxon )
Study ID Numbers:	X07- 0052
First Received:	June 28, 2007
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00494117
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Heart Failure

Sleep Apnea Syndromes

Heart Diseases

Respiratory Tract Diseases

Apnea

Respiration Disorders

Dyssomnias

Sleep Disorders

Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	ResMed
Information provided by:	ResMed
ClinicalTrials.gov Identifier:	NCT00494117