The Cyclocapnic Method for Measurement of Chemosensitivity

January 13, 2010 updated by: Imperial College London

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chemoreflex gain as measured by cyclocapnic method
Time Frame: every minute
every minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Darrel P Francis, MD, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 13, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/H0712/129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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