Chemoreflex Gain on Exercise

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01050179
First received: January 13, 2010
Last updated: April 16, 2010
Last verified: April 2010

January 13, 2010
April 16, 2010
February 2010
October 2010   (final data collection date for primary outcome measure)
chemoreflex gain on exercise [ Time Frame: every minute ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01050179 on ClinicalTrials.gov Archive Site
Reproducibility of chemoreflex gain on exercise [ Time Frame: every minute ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Chemoreflex Gain on Exercise
Chemoreflex Gain on Exercise

The purpose of this study is to assess chemoreflex gain on exercise.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Exertional Periodic Breathing
Other: carbon dioxide
sinusoidal carbon dioxide delivery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years to 80 Years
Yes
Contact: Darrel P Francis, MD +44 207 594 1093 darrel.francis@imperial.ac.uk
United Kingdom
 
NCT01050179
10/H0712/9
No
Darrel Francis, Imperial College
Imperial College London
Not Provided
Not Provided
Imperial College London
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP