NCT00494117

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

Enrollment Period

2.8 years

First QC Date

June 28, 2007

Last Update Submit

July 25, 2010

Conditions

Heart Failure, CongestiveSleep Apnea Syndromes

Interventions

ApneaLinkDEVICE

A two channel sleep screening device for the assessment of Sleep Disordered Breathing.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

MeSH Terms

Conditions

Heart FailureSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 28, 2007

First Posted

June 29, 2007

Study Start

June 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

AU(1)