NCT01050179

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 19, 2010

Status Verified

April 1, 2010

Enrollment Period

8 months

First QC Date

January 13, 2010

Last Update Submit

April 16, 2010

Conditions

Exertional Periodic Breathing

Keywords

chemosensitivity

Outcome Measures

Primary Outcomes (1)

  • chemoreflex gain on exercise

    every minute

Secondary Outcomes (1)

  • Reproducibility of chemoreflex gain on exercise

    every minute

Interventions

carbon dioxideOTHER

sinusoidal carbon dioxide delivery

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's Hospital

Paddington, London, W2 1LA, United Kingdom

RECRUITING

MeSH Terms

Interventions

Carbon Dioxide

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen Compounds

Central Study Contacts

Darrel P Francis, MD

CONTACT

+44 207 594 1093darrel.francis@imperial.ac.uk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 15, 2010

Study Start

February 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

April 19, 2010

Record last verified: 2010-04

Locations

GB(1)