Heart Failure, CongestiveNCT00495196
Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration
A study testing Experimental lung function test in people with Heart Failure, Congestive and Cheyne-Stokes Respiration, run by ResMed at 1 site in Australia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Congestive, Cheyne-Stokes Respiration
- What is being tested?
- Experimental lung function test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
About this study
Official title: 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
- Being tested
- Experimental lung function test
- Medical subject headings
- Heart Failure, Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental lung function testProcedure or surgery
Administration of several CO2 gas mixtures
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Experimental lung function test |
| 2 | Active comparator | Not described Receives: Procedure: Experimental lung function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular parameters such as continuous blood pressure and heart rate.
Measured: During administration of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rachel A Coxon, BE/MBiomedE, Study director, ResMed/The University of New South WalesKlaus Schindhelm, PhD, Study director, ResMed/The University of New South WalesJodie Lattimore, PhD, Study director, Royal Prince Alfred Hospital, Sydney, AustraliaIan Wilcox, PhD, Principal investigator, Royal Prince Alfred Hospital/The University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495196
- Sponsor's protocol ID
- X07-0079
- Status last verified
- Jul 2010
- First submitted
- 28 Jun 2007
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Response to Peripheral Chemoreceptor Stimulation in Congestive Heart Failure With Cheyne- Stokes Respiration
- ClinicalTrials.gov ID
- NCT00495196
- Acronym / sponsor ID
- X07-0079
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to investigate the cardiovascular response to peripheral chemoreceptor stimulation in Congestive Heart Failure with Cheyne- Stokes Respiration
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Experimental lung function test |
| 2 | Active comparator | Procedure: Experimental lung function test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental lung function testAdministration of several CO2 gas mixtures | Procedure or surgery | 1, 2 |
Primary outcome
Cardiovascular parameters such as continuous blood pressure and heart rate.
Time frame: During administration of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel A Coxon, BE/MBiomedE study director
ResMed/The University of New South Wales
Klaus Schindhelm, PhD study director
ResMed/The University of New South Wales
Jodie Lattimore, PhD study director
Royal Prince Alfred Hospital, Sydney, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental lung function test in people with Heart Failure, Congestive and Cheyne-Stokes Respiration, run by ResMed at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular parameters such as continuous blood pressure and heart rate. (time frame: During administration of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2010.