Back to resultsEffect of Short-term Oxygen During CPET in GUCH
Primary Purpose
Grown-up Congenital Heart Disease (GUCH)
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Oxygen application
Sham room air
Sponsored by
About this trial
This is an interventional supportive care trial for Grown-up Congenital Heart Disease (GUCH)
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich, Division of Pneumology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Supplemental oxygen
Sham room air
Arm Description
Supplemental oxygen will be applied via a mask during CPET
Room air will be applied similarly to oxygen
Outcomes
Primary Outcome Measures
Work Rate (Watt)
Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air
Endurance Time (s) Endurance Time (s) Endurance Time (s)
Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air
Secondary Outcome Measures
Peak Oxygen uptake
measured during cardiopulmonary exercise test oxygen vs. room air
Respiratory Exchange ratio
measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters
measured during cardiopulmonary exercise test oxygen vs. room air
muscle tissue oxygen
Oxygen saturation in the muscle measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
cerebral tissue oxygen
Oxygen saturation in the brain measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04076501
Brief Title
Effect of Short-term Oxygen During CPET in GUCH
Official Title
Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Grown-up Congenital Heart Disease (GUCH)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grown-up Congenital Heart Disease (GUCH)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supplemental oxygen
Arm Type
Experimental
Arm Description
Supplemental oxygen will be applied via a mask during CPET
Arm Title
Sham room air
Arm Type
Sham Comparator
Arm Description
Room air will be applied similarly to oxygen
Intervention Type
Procedure
Intervention Name(s)
Oxygen application
Intervention Description
Oxygen application Supplemental oxygen via mask
Intervention Type
Procedure
Intervention Name(s)
Sham room air
Intervention Description
Room air applied via mask
Primary Outcome Measure Information:
Title
Work Rate (Watt)
Description
Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
Endurance Time (s) Endurance Time (s) Endurance Time (s)
Description
Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Peak Oxygen uptake
Description
measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
Respiratory Exchange ratio
Description
measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
Changes in arterial blood parameters
Description
measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
muscle tissue oxygen
Description
Oxygen saturation in the muscle measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
Time Frame
1 day
Title
cerebral tissue oxygen
Description
Oxygen saturation in the brain measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Zurich, Division of Pneumology
City
Zürich
ZIP/Postal Code
, 8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Short-term Oxygen During CPET in GUCH
We'll reach out to this number within 24 hrs