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The Cyclocapnic Method for Measurement of Chemosensitivity

Primary Purpose

Periodic Breathing, Heart Failure

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
carbon dioxide
Sponsored by
Imperial College London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Periodic Breathing focused on measuring Periodic breathing, Heart Failure, Chemoreflex, Chemosensitivity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Heart failure subjects with stable cardiorespiratory control to be recruited from our institution's specialist heart failure clinic.
  • Normal healthy volunteers, with normal systolic function.

Exclusion Criteria:

  • We will exclude patients with chronic respiratory disease (every patient will have formal lung function testing on entrance into the study) or unstable coronary artery disease (myocardial infarction or unstable angina within the past 3 months).
  • In addition any subjects receiving treatment with morphine and derivatives, theophylline, oxygen, benzodiazepines or acetazolamide will be excluded as these affect chemosensitivity.

Sites / Locations

  • St Mary's HospitalRecruiting

Outcomes

Primary Outcome Measures

Chemoreflex gain as measured by cyclocapnic method

Secondary Outcome Measures

Full Information

First Posted
January 13, 2010
Last Updated
January 13, 2010
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT01049256
Brief Title
The Cyclocapnic Method for Measurement of Chemosensitivity
Official Title
Developing an Improved Measure of Chemosensitivity for the Study of Periodic Breathing in Heart Failure: the Cyclocapnic Method
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 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
We aim to test our method for measuring chemosensitivity (the ventilatory response to a change in carbon dioxide), which uses sinusoidal carbon dioxide stimuli. Hypotheses: Carbon dioxide sensitivity is dependent on the cycle time over which we administer the gas (frequency). Chemoreflex gain decreases as deadspace increases.
Detailed Description
We will apply a new method for the measurement of chemosensitivity (how sensitive a person is to changes in carbon dioxide), which is one of the principle determinants of whether people with heart failure develop abnormal breathing patterns We have shown in a pilot study that administering sinusoidal patterns of inspired carbon dioxide produces similar sinusoidal responses in ventilation. We aim to test our method for measuring chemosensitivity, which uses sinusoidal carbon dioxide stimuli (similar to those that drive the oscillations in ventilation found in periodic breathing). We aim to show that how the cycle time of carbon dioxide administered affects the resulting ventilatory oscillations and therefore that when measuring the chemoreflex clinically, it is important to deliver carbon dioxide stimuli that replicate the cycle time of oscillations in carbon dioxide seen in periodic breathing (typically approximately one minute).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodic Breathing, Heart Failure
Keywords
Periodic breathing, Heart Failure, Chemoreflex, Chemosensitivity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
carbon dioxide
Intervention Description
sinusoidal carbon dioxide administration
Primary Outcome Measure Information:
Title
Chemoreflex gain as measured by cyclocapnic method
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: Heart failure subjects with stable cardiorespiratory control to be recruited from our institution's specialist heart failure clinic. Normal healthy volunteers, with normal systolic function. Exclusion Criteria: We will exclude patients with chronic respiratory disease (every patient will have formal lung function testing on entrance into the study) or unstable coronary artery disease (myocardial infarction or unstable angina within the past 3 months). In addition any subjects receiving treatment with morphine and derivatives, theophylline, oxygen, benzodiazepines or acetazolamide will be excluded as these affect chemosensitivity.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrel P Francis, MD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Mary's Hospital
City
London
ZIP/Postal Code
W2 1LA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Resham Baruah, MB BS
Phone
020 75941027
Email
resham.baruah@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Darrel P Francis, MD
Phone
+44 207 594 1093
Email
darrel.francis@imperial.ac.uk

12. IPD Sharing Statement

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The Cyclocapnic Method for Measurement of Chemosensitivity

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