Grown-up Congenital Heart Disease (GUCH)
Conditions
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.
Interventions
PROCEDUREOxygen application
Oxygen application Supplemental oxygen via mask
PROCEDURESham room air
Room air applied via mask
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work Rate (Watt) | 1 day | Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air |
| Endurance Time (s) Endurance Time (s) Endurance Time (s) | 1 day | Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in arterial blood parameters | 1 day | measured during cardiopulmonary exercise test oxygen vs. room air |
| Peak Oxygen uptake | 1 day | measured during cardiopulmonary exercise test oxygen vs. room air |
| cerebral tissue oxygen | 1 day | Oxygen saturation in the brain measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy |
| muscle tissue oxygen | 1 day | Oxygen saturation in the muscle measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy |
| Respiratory Exchange ratio | 1 day | measured during cardiopulmonary exercise test oxygen vs. room air |
Countries
Switzerland
Outcome results
None listed