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The Cyclocapnic Method for Measurement of Chemosensitivity

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ClinicalTrials.gov Identifier: NCT01049256
Recruitment Status : Unknown
Verified January 2010 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : January 14, 2010
Last Update Posted : January 14, 2010
Sponsor:
Information provided by:
Imperial College London

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.

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

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Developing an Improved Measure of Chemosensitivity for the Study of Periodic Breathing in Heart Failure: the Cyclocapnic Method
Study Start Date : January 2008
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources


Intervention Details:
    Other: carbon dioxide
    sinusoidal carbon dioxide administration


Primary Outcome Measures :
  1. Chemoreflex gain as measured by cyclocapnic method [ Time Frame: every minute ]


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

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): NCT01049256


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

Locations
United Kingdom
St Mary's Hospital Recruiting
London, United Kingdom, W2 1LA
Contact: Resham Baruah, MB BS    020 75941027    resham.baruah@imperial.ac.uk   
Contact: Darrel P Francis, MD    +44 207 594 1093    darrel.francis@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Darrel P Francis, MD Imperial College London

Responsible Party: Darrel Francis, Imperial College
ClinicalTrials.gov Identifier: NCT01049256     History of Changes
Other Study ID Numbers: 07/H0712/129
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by Imperial College London:
Periodic breathing
Heart Failure
Chemoreflex
Chemosensitivity

Additional relevant MeSH terms:
Heart Failure
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes