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Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration

This study has been completed.
Sponsor:
Information provided by:
ResMed
ClinicalTrials.gov Identifier:
NCT00495196
First received: June 28, 2007
Last updated: July 25, 2010
Last verified: July 2010

June 28, 2007
July 25, 2010
June 2007
March 2010   (final data collection date for primary outcome measure)
Cardiovascular parameters such as continuous blood pressure and heart rate. [ Time Frame: During administration of the intervention ] [ Designated as safety issue: No ]
Cardiovascular variables such as heart rate and blood pressure [ Time Frame: During administration of intervention ]
Complete list of historical versions of study NCT00495196 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration
Cardiovascular Response to Peripheral Chemoreceptor Stimulation in Congestive Heart Failure With Cheyne- Stokes Respiration

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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Heart Failure, Congestive
  • Cheyne-Stokes Respiration
Procedure: Experimental lung function test
Administration of several CO2 gas mixtures
  • Experimental: 1
    Intervention: Procedure: Experimental lung function test
  • Active Comparator: 2
    Intervention: Procedure: Experimental lung function test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00495196
X07-0079
No
Rachel Coxon, ResMed
ResMed
Not Provided
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
ResMed
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP