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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00495196
Other study ID # X07-0079
Secondary ID
Status Completed
Phase N/A
First received June 28, 2007
Last updated July 25, 2010
Start date June 2007
Est. completion date March 2010

Study information

Verified date July 2010
Source ResMed
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design

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


Intervention

Procedure:
Experimental lung function test
Administration of several CO2 gas mixtures

Locations

Country Name City State
Australia Royal Prince Alfred Hospital Camperdown New South Wales

Sponsors (1)

Lead Sponsor Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiovascular parameters such as continuous blood pressure and heart rate. During administration of the intervention No
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