NCT00495196

Brief Summary

The purpose of the trial is to investigate the cardiovascular response to peripheral chemoreceptor stimulation in Congestive Heart Failure with Cheyne- Stokes Respiration

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 not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

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
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 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, CongestiveCheyne-Stokes Respiration

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular parameters such as continuous blood pressure and heart rate.

    During administration of the intervention

Study Arms (2)

1

EXPERIMENTAL
Procedure: Experimental lung function test

2

ACTIVE COMPARATOR
Procedure: Experimental lung function test

Interventions

Experimental lung function testPROCEDURE

Administration of several CO2 gas mixtures

12

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe heart failure (NYHA Class II or above) on optimal medical therapy
  • LVEF less than or equal to 45%
  • Stable condition as defined as no hospital admission or changes to medical therapy within two weeks prior to enrolment

You may not qualify if:

  • Patients taking known respiratory stimulants or depressants
  • Clinically significant asthma requiring therapy
  • Significant parenchymal lung disease
  • Primary pulmonary hypertension
  • Myocardial infarction within three months prior to enrolment
  • Patients with cardiac resynchronisation devices and permanent pacemakers
  • Anaemic (haemoglobin \< 12g/dL)

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 FailureCheyne-Stokes Respiration

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

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
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 28, 2007

First Posted

July 2, 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)