Chemoreflex Gain on Exercise

Exertional Periodic Breathing Clinical Trial

Official title:

Chemoreflex Gain on Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01050179
• Other study ID #: 10/H0712/9
• Status: Recruiting
• Phase: Phase 1
• First received: January 13, 2010
• Last updated: April 16, 2010
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: April 2010
• Source: Imperial College London
• Contact: Darrel P Francis, MD
• Phone: +44 207 594 1093
• Email: darrel.francis[@]imperial.ac.uk
• Is FDA regulated: No
• Health authority: UK: National research and ethics committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Exertional Periodic Breathing

Intervention

Other:
• carbon dioxide
sinusoidal carbon dioxide delivery

Locations

Country	Name	City	State
United Kingdom	St Mary's Hospital	Paddington	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chemoreflex gain on exercise		every minute	No
Secondary	Reproducibility of chemoreflex gain on exercise		every minute	No