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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
History of Changes
  Purpose

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


Condition Intervention
Heart Failure, Congestive
Cheyne-Stokes Respiration
 Procedure: Experimental lung function test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Cardiovascular Response to Peripheral Chemoreceptor Stimulation in Congestive Heart Failure With Cheyne- Stokes Respiration

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by ResMed:

Primary Outcome Measures:
  • Cardiovascular parameters such as continuous blood pressure and heart rate. [ Time Frame: During administration of the intervention ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Experimental lung function test
Administration of several CO2 gas mixtures
Active Comparator: 2 Procedure: Experimental lung function test
Administration of several CO2 gas mixtures

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495196

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Sponsors and Collaborators
ResMed
Investigators
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
  More Information

No publications provided

Responsible Party: Rachel Coxon, ResMed
ClinicalTrials.gov Identifier: NCT00495196     History of Changes
Other Study ID Numbers: X07-0079
Study First Received: June 28, 2007
Last Updated: July 25, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Cheyne-Stokes Respiration
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013