Investigation of Heart Failure Status Over Time Using Res... | NCT00494117

Studies
Investigation of Heart Failure Status Over Time Using Respiratory Parameters

NCT00494117

Sponsor

ResMed

Status

Completed

Last Update Posted

Jul 27, 2010Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Heart Failure, Congestive
Sleep Apnea Syndromes

Interventions

ApneaLink

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jun 28, 2007

First Submission Date that Met QC Criteria

Jun 28, 2007

First Posted Date

Jun 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2010

Last Update Posted Date

Jul 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
ApneaLink	Device	A two channel sleep screening device for the assessment of Sleep Disordered Breathing.

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The population under investigation is moderate to severe heart failure who are outpatients of a major Sydney hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Study Director
Ian Wilcox, PhD	Royal Prince Alfred Hospital/The University of Sydney	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Prince Alfred Hospital		Camperdown	New South Wales	2050	Australia

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001049	Apnea
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided