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Clinical Trials/NCT01049256
NCT01049256UnknownPhase 1

Developing an Improved Measure of Chemosensitivity for the Study of Periodic Breathing in Heart Failure: the Cyclocapnic Method

Imperial College London1 site in 1 country45 target enrollmentStarted: January 1, 2008Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Enrollment
45
Locations
1
Primary Endpoint
Chemoreflex gain as measured by cyclocapnic method

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Chemoreflex gain as measured by cyclocapnic method

Time Frame: every minute

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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