Effect of Short-term Oxygen During CPET in GUCH
April 16, 2021 updated by: University of Zurich
Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Grown-up Congenital Heart Disease (GUCH)
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with grown-up congenital heart disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
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
-
-
-
Zürich, Switzerland, , 8091
- University Hospital Zurich, Division of Pneumology
-
-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- GUCH, stable medication for at least 4 weeks.
Exclusion Criteria:
- instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
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: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Supplemental oxygen
Supplemental oxygen will be applied via a mask during CPET
|
Oxygen application Supplemental oxygen via mask
|
|
SHAM_COMPARATOR: Sham room air
Room air will be applied similarly to oxygen
|
Room air applied via mask
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Work Rate (Watt)
Time Frame: 1 day
|
Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air
|
1 day
|
|
Endurance Time (s) Endurance Time (s) Endurance Time (s)
Time Frame: 1 day
|
Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Oxygen uptake
Time Frame: 1 day
|
measured during cardiopulmonary exercise test oxygen vs. room air
|
1 day
|
|
Respiratory Exchange ratio
Time Frame: 1 day
|
measured during cardiopulmonary exercise test oxygen vs. room air
|
1 day
|
|
Changes in arterial blood parameters
Time Frame: 1 day
|
measured during cardiopulmonary exercise test oxygen vs. room air
|
1 day
|
|
muscle tissue oxygen
Time Frame: 1 day
|
Oxygen saturation in the muscle measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
|
1 day
|
|
cerebral tissue oxygen
Time Frame: 1 day
|
Oxygen saturation in the brain measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
September 12, 2019
Primary Completion (ACTUAL)
December 31, 2020
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
August 30, 2019
First Submitted That Met QC Criteria
August 30, 2019
First Posted (ACTUAL)
September 3, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2021
Last Update Submitted That Met QC Criteria
April 16, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-NR. 2012-0251_4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.