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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on November 19, 2014