Exertional Periodic BreathingPhase 1NCT01050179
Chemoreflex Gain on Exercise
A Phase 1 study testing carbon dioxide in people with Exertional Periodic Breathing, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess chemoreflex gain on exercise. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exertional Periodic Breathing
- What is being tested?
- carbon dioxide
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Oct 2010
- Phase
- Phase 1
- 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 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers: Males aged 18-80 years who are able to perform both running and cycling and can follow simple visual instructions.
- Heart Failure Subjects: Males aged 18-80 with a clinical diagnosis of heart failure who are able to perform both running and cycling and can follow simple visual instructions.
Who cannot join
- Chest pain of any cause within 4-6 days,
- Pulmonary oedema,
- Uncontrolled hypertension (systolic blood pressure > 220 mm Hg, diastolic >120 mm Hg),
- Severe aortic stenosis,
- Severe hypertrophic obstructive cardiomyopathy,
- Untreated life threatening arrhythmia,
- Dissecting aneurysm,
- Recent surgery (within 4-6 weeks), COPD.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Mary's Hospital
Paddington, London, W2 1LA
Resham Baruah, MBBS, 02075941027, resham.baruah@imperial.ac.uk
Darrel P Francis, MD
About this study
The purpose of this study is to assess chemoreflex gain on exercise.
Read the detailed description
Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (CO2) in the blood. The change in breathing that results from a change in the blood's CO2 concentration is called the chemoreflex.
In heart failure, a condition where the heart muscle is damaged and can not pump as well, this reflex is exaggerated. The result of this can be breathing conditions characterised by patients hyperventilating at times and at other times taking very shallow breaths or even stopping altogether. In the past the only way of measuring this chemoreflex was to get patients to breathe into a large container and to rebreathe their exhaled air and allow the CO2 to rise over time, whilst keeping the oxygen constant. The proportion by which the ventilation increases with increasing carbon dioxide is the chemoreflex gain. Unfortunately, because this test takes a long time to conduct, requires specialist knowledge and equipment it has not been possible to measure this reflex on exercise.
- Conditions
- Exertional Periodic Breathing
- Being tested
- carbon dioxide
- Keywords
- chemosensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon dioxideOther
sinusoidal carbon dioxide delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
chemoreflex gain on exercise
Measured: every minute
Secondary outcomes (1)
Reproducibility of chemoreflex gain on exercise
Measured: every minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exertional Periodic BreathingStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050179
- Sponsor's protocol ID
- 10/H0712/9
- Status last verified
- Apr 2010
- First submitted
- 13 Jan 2010
- Last updated
- 19 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoreflex Gain on Exercise
- ClinicalTrials.gov ID
- NCT01050179
- Acronym / sponsor ID
- 10/H0712/9
- Conditions
- Exertional Periodic Breathing
- Keywords
- chemosensitivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 15 Jan 2010 (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 this study is to assess chemoreflex gain on exercise.
Detailed description
Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (CO2) in the blood. The change in breathing that results from a change in the blood's CO2 concentration is called the chemoreflex.
In heart failure, a condition where the heart muscle is damaged and can not pump as well, this reflex is exaggerated. The result of this can be breathing conditions characterised by patients hyperventilating at times and at other times taking very shallow breaths or even stopping altogether. In the past the only way of measuring this chemoreflex was to get patients to breathe into a large container and to rebreathe their exhaled air and allow the CO2 to rise over time, whilst keeping the oxygen constant. The proportion by which the ventilation increases with increasing carbon dioxide is the chemoreflex gain. Unfortunately, because this test takes a long time to conduct, requires specialist knowledge and equipment it has not been possible to measure this reflex on exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteers: Males aged 18-80 years who are able to perform both running and cycling and can follow simple visual instructions.
- Heart Failure Subjects: Males aged 18-80 with a clinical diagnosis of heart failure who are able to perform both running and cycling and can follow simple visual instructions.
Key exclusion criteria (8 listed)
- Chest pain of any cause within 4-6 days,
- Pulmonary oedema,
- Uncontrolled hypertension (systolic blood pressure > 220 mm Hg, diastolic >120 mm Hg),
- Severe aortic stenosis,
- Severe hypertrophic obstructive cardiomyopathy,
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 |
|---|---|---|
| carbon dioxidesinusoidal carbon dioxide delivery | Other | – |
Primary outcome
chemoreflex gain on exercise
Time frame: every minute
1 secondary outcome
Reproducibility of chemoreflex gain on exercise
Time frame: every minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carbon dioxide in people with Exertional Periodic Breathing, run by Imperial College London at 1 site in United Kingdom.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Apr 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 United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darrel P Francis, MD (+44 207 594 1093, darrel.francis@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chemoreflex gain on exercise (time frame: every minute). 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 19 Apr 2010.