Effect of Short-term Oxygen During CPET in GUCH

Grown-up Congenital Heart Disease (GUCH) Clinical Trial

Official title:

Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Grown-up Congenital Heart Disease (GUCH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076501
• Other study ID #: KEK-ZH-NR. 2012-0251_4
• Status: Completed
• Phase: N/A
• Start date: September 12, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Grown-up Congenital Heart Disease (GUCH)
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• Oxygen application
Oxygen application Supplemental oxygen via mask
• Sham room air
Room air applied via mask

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Pneumology	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work Rate (Watt)	Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air	1 day
Primary	Endurance Time (s) Endurance Time (s) Endurance Time (s)	Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air	1 day
Secondary	Peak Oxygen uptake	measured during cardiopulmonary exercise test oxygen vs. room air	1 day
Secondary	Respiratory Exchange ratio	measured during cardiopulmonary exercise test oxygen vs. room air	1 day
Secondary	Changes in arterial blood parameters	measured during cardiopulmonary exercise test oxygen vs. room air	1 day
Secondary	muscle tissue oxygen	Oxygen saturation in the muscle measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy	1 day
Secondary	cerebral tissue oxygen	Oxygen saturation in the brain measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy	1 day