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

Tracking Information

First Received Date ^ICMJE

June 28, 2007

Last Updated Date

July 25, 2010

Start Date ^ICMJE

June 2007

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Cardiovascular variables such as heart rate and blood pressure [ Time Frame: During administration of intervention ]

Change History

Complete list of historical versions of study NCT00495196 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration

Official Title ^ICMJE

Cardiovascular Response to Peripheral Chemoreceptor Stimulation in Congestive Heart Failure With Cheyne- Stokes Respiration

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Heart Failure, Congestive
Cheyne-Stokes Respiration

Intervention ^ICMJE

Procedure: Experimental lung function test

Administration of several CO2 gas mixtures

Study Arm (s)

Experimental: 1
Intervention: Procedure: Experimental lung function test
Active Comparator: 2
Intervention: Procedure: Experimental lung function test

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00495196

Other Study ID Numbers ^ICMJE

X07-0079

Has Data Monitoring Committee

Responsible Party

Rachel Coxon, ResMed

Study Sponsor ^ICMJE

ResMed

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

ResMed

Verification Date

July 2010

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

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