Back to resultsCardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration
Primary Purpose
Heart Failure, Congestive, Cheyne-Stokes Respiration
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Experimental lung function test
Sponsored by
About this trial
This is an interventional basic science trial for Heart Failure, Congestive
Eligibility Criteria
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)
Sites / Locations
- Royal Prince Alfred Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Cardiovascular parameters such as continuous blood pressure and heart rate.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00495196
Brief Title
Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration
Official Title
Cardiovascular Response to Peripheral Chemoreceptor Stimulation in Congestive Heart Failure With Cheyne- Stokes Respiration
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ResMed
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Cheyne-Stokes Respiration
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Experimental lung function test
Intervention Description
Administration of several CO2 gas mixtures
Primary Outcome Measure Information:
Title
Cardiovascular parameters such as continuous blood pressure and heart rate.
Time Frame
During administration of the intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel A Coxon, BE/MBiomedE
Organizational Affiliation
ResMed/The University of New South Wales
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm, PhD
Organizational Affiliation
ResMed/The University of New South Wales
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jodie Lattimore, PhD
Organizational Affiliation
Royal Prince Alfred Hospital, Sydney, Australia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ian Wilcox, PhD
Organizational Affiliation
Royal Prince Alfred Hospital/The University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
12. IPD Sharing Statement
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Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration
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