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CompletedNCT04076501Updated Apr 19, 2021

Effect of Short-term Oxygen During CPET in GUCH

An interventional study of Oxygen application and Sham room air in Grown-up Congenital Heart Disease (GUCH), sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-19.

Sponsored by University of Zurich · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Grown-up Congenital Heart Disease (GUCH)
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 7 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • GUCH, stable medication for at least 4 weeks.

Exclusion criteria

Exclusion Criteria:

  • instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Supplemental oxygen

    Supplemental oxygen will be applied via a mask during CPET

    Procedure: Oxygen application

  • Sham comparator
    Sham room air

    Room air will be applied similarly to oxygen

    Procedure: Sham room air

Interventions

  • ProcedureOxygen application

    Oxygen application Supplemental oxygen via mask

  • ProcedureSham room air

    Room air applied via mask

06

What researchers measure

Primary outcomes

  1. Work Rate (Watt)

    Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air

    Time frame: 1 day

  2. Endurance Time (s) Endurance Time (s) Endurance Time (s)

    Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air

    Time frame: 1 day

Secondary outcomes

  1. Peak Oxygen uptake

    measured during cardiopulmonary exercise test oxygen vs. room air

    Time frame: 1 day

  2. Respiratory Exchange ratio

    measured during cardiopulmonary exercise test oxygen vs. room air

    Time frame: 1 day

  3. Changes in arterial blood parameters

    measured during cardiopulmonary exercise test oxygen vs. room air

    Time frame: 1 day

  4. muscle tissue oxygen

    Oxygen saturation in the muscle measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy

    Time frame: 1 day

  5. cerebral tissue oxygen

    Oxygen saturation in the brain measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy

    Time frame: 1 day

07

Study locations

1 site
  • University Hospital Zurich, Division of Pneumology
    Zürich, , 8091, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04076501
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Sep 3, 2019
Start date
Sep 12, 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Apr 19, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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