Effect of Short-term Oxygen During CPET in GUCH

Not Applicable

Completed

• Conditions: Grown-up Congenital Heart Disease (GUCH)
• Interventions: Procedure: Oxygen application; Procedure: Sham room air

• Registration Number: NCT04076501
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Study Start: 2019-09-12
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supplemental oxygen	Oxygen application	Supplemental oxygen will be applied via a mask during CPET
Sham room air	Sham room air	Room air will be applied similarly to oxygen

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Peak Oxygen uptake	1 day	measured during cardiopulmonary exercise test oxygen vs. room air
Respiratory Exchange ratio	1 day	measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters	1 day	measured during cardiopulmonary exercise test oxygen vs. room air
muscle tissue oxygen	1 day	Oxygen saturation in the muscle measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
cerebral tissue oxygen	1 day	Oxygen saturation in the brain measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy

Trial Locations

Locations (1)

University Hospital Zurich, Division of Pneumology; 🇨🇭 Zürich, Switzerland