Chemoreflex Gain on Exercise
Primary Purpose
Exertional Periodic Breathing
Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
carbon dioxide
Sponsored by
About this trial
This is an interventional basic science trial for Exertional Periodic Breathing focused on measuring chemosensitivity
Eligibility 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.
Sites / Locations
- St Mary's HospitalRecruiting
Outcomes
Primary Outcome Measures
chemoreflex gain on exercise
Secondary Outcome Measures
Reproducibility of chemoreflex gain on exercise
Full Information
NCT ID
NCT01050179
First Posted
January 13, 2010
Last Updated
April 16, 2010
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT01050179
Brief Title
Chemoreflex Gain on Exercise
Official Title
Chemoreflex Gain on Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exertional Periodic Breathing
Keywords
chemosensitivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
carbon dioxide
Intervention Description
sinusoidal carbon dioxide delivery
Primary Outcome Measure Information:
Title
chemoreflex gain on exercise
Time Frame
every minute
Secondary Outcome Measure Information:
Title
Reproducibility of chemoreflex gain on exercise
Time Frame
every minute
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darrel P Francis, MD
Phone
+44 207 594 1093
Email
darrel.francis@imperial.ac.uk
Facility Information:
Facility Name
St Mary's Hospital
City
Paddington
State/Province
London
ZIP/Postal Code
W2 1LA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Resham Baruah, MBBS
Phone
02075941027
Email
resham.baruah@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Darrel P Francis, MD
12. IPD Sharing Statement
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Chemoreflex Gain on Exercise
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