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Chemoreflex Gain on Exercise

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ClinicalTrials.gov Identifier: NCT01050179
Recruitment Status : Unknown
Verified April 2010 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : January 15, 2010
Last Update Posted : April 19, 2010
Sponsor:
Information provided by:
Imperial College London

Brief Summary:
The purpose of this study is to assess chemoreflex gain on exercise.

Condition or disease Intervention/treatment Phase
Exertional Periodic Breathing Other: carbon dioxide Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Chemoreflex Gain on Exercise
Study Start Date : February 2010
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: carbon dioxide
    sinusoidal carbon dioxide delivery


Primary Outcome Measures :
  1. chemoreflex gain on exercise [ Time Frame: every minute ]

Secondary Outcome Measures :
  1. Reproducibility of chemoreflex gain on exercise [ Time Frame: every minute ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050179


Contacts
Contact: Darrel P Francis, MD +44 207 594 1093 darrel.francis@imperial.ac.uk

Locations
United Kingdom
St Mary's Hospital Recruiting
Paddington, London, United Kingdom, W2 1LA
Contact: Resham Baruah, MBBS    02075941027    resham.baruah@imperial.ac.uk   
Principal Investigator: Darrel P Francis, MD         
Sponsors and Collaborators
Imperial College London

Responsible Party: Darrel Francis, Imperial College
ClinicalTrials.gov Identifier: NCT01050179     History of Changes
Other Study ID Numbers: 10/H0712/9
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: April 19, 2010
Last Verified: April 2010

Keywords provided by Imperial College London:
chemosensitivity