Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration

July 25, 2010 updated by: ResMed

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular parameters such as continuous blood pressure and heart rate.
Time Frame: During administration of the intervention
During administration of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 28, 2007

First Submitted That Met QC Criteria

June 28, 2007

First Posted (Estimate)

July 2, 2007

Study Record Updates

Last Update Posted (Estimate)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 25, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X07-0079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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