Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration

NCT ID: NCT00495196

Last Updated: 2010-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Heart Failure, Congestive Cheyne-Stokes Respiration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Experimental lung function test

Intervention Type PROCEDURE

Administration of several CO2 gas mixtures

2

Group Type ACTIVE_COMPARATOR

Experimental lung function test

Intervention Type PROCEDURE

Administration of several CO2 gas mixtures

Interventions

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Experimental lung function test

Administration of several CO2 gas mixtures

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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ResMed

Principal Investigators

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Rachel A Coxon, BE/MBiomedE

Role: STUDY_DIRECTOR

ResMed/The University of New South Wales

Klaus Schindhelm, PhD

Role: STUDY_DIRECTOR

ResMed/The University of New South Wales

Jodie Lattimore, PhD

Role: STUDY_DIRECTOR

Royal Prince Alfred Hospital, Sydney, Australia

Ian Wilcox, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Prince Alfred Hospital/The University of Sydney

Locations

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Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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X07-0079

Identifier Type: -

Identifier Source: org_study_id

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