Chemoreflex Gain on Exercise
Recruitment status was Recruiting
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 13, 2010 | ||||
| Last Updated Date | April 16, 2010 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
chemoreflex gain on exercise [ Time Frame: every minute ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01050179 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Reproducibility of chemoreflex gain on exercise [ Time Frame: every minute ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chemoreflex Gain on Exercise | ||||
| Official Title ICMJE | Chemoreflex Gain on Exercise | ||||
| Brief Summary | The purpose of this study is to assess chemoreflex gain on exercise. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Exertional Periodic Breathing | ||||
| Intervention ICMJE | Other: carbon dioxide
sinusoidal carbon dioxide delivery |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | October 2010 | ||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01050179 | ||||
| Other Study ID Numbers ICMJE | 10/H0712/9 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Darrel Francis, Imperial College | ||||
| Study Sponsor ICMJE | Imperial College London | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Imperial College London | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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