Grown-up Congenital Heart Disease (GUCH)NCT04076501
Effect of Short-term Oxygen During CPET in GUCH
A study testing Oxygen application in people with Grown-up Congenital Heart Disease (GUCH), run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Grown-up Congenital Heart Disease (GUCH)
- What is being tested?
- Oxygen application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Sep 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GUCH, stable medication for at least 4 weeks.
Who cannot join
- instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Pneumology
Zurich, , 8091
About this study
Official title: Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Grown-up Congenital Heart Disease (GUCH)
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.
- Conditions
- Grown-up Congenital Heart Disease (GUCH)
- Being tested
- Oxygen application, Sham room air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen applicationProcedure or surgery
Oxygen application Supplemental oxygen via mask
Sham room airProcedure or surgery
Room air applied via mask
| Study group | Role | What they receive |
|---|---|---|
| Supplemental oxygen | Experimental | Supplemental oxygen will be applied via a mask during CPET Receives: Procedure: Oxygen application |
| Sham room air | Sham comparator | Room air will be applied similarly to oxygen Receives: Procedure: Sham room air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Rate (Watt)
Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air
Measured: 1 day
Endurance Time (s) Endurance Time (s) Endurance Time (s)
Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air
Measured: 1 day
Secondary outcomes (5)
Peak Oxygen uptake
measured during cardiopulmonary exercise test oxygen vs. room air
Measured: 1 day
Respiratory Exchange ratio
measured during cardiopulmonary exercise test oxygen vs. room air
Measured: 1 day
Changes in arterial blood parameters
measured during cardiopulmonary exercise test oxygen vs. room air
Measured: 1 day
muscle tissue oxygen
Oxygen saturation in the muscle measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
Measured: 1 day
cerebral tissue oxygen
Oxygen saturation in the brain measured during cardiopulmonary exercise test oxygen vs. room air with near infrared spectroscopy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start12 Sep 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grown-up Congenital Heart Disease (GUCH)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076501
- Sponsor's protocol ID
- KEK-ZH-NR. 2012-0251_4
- Status last verified
- Apr 2021
- First submitted
- 30 Aug 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Grown-up Congenital Heart Disease (GUCH)
- ClinicalTrials.gov ID
- NCT04076501
- Acronym / sponsor ID
- KEK-ZH-NR. 2012-0251_4
- Conditions
- Grown-up Congenital Heart Disease (GUCH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental oxygen | Experimental | Procedure: Oxygen applicationSupplemental oxygen will be applied via a mask during CPET |
| Sham room air | Sham comparator | Procedure: Sham room airRoom air will be applied similarly to oxygen |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- GUCH, stable medication for at least 4 weeks.
Key exclusion criteria (1 listed)
- instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen applicationOxygen application Supplemental oxygen via mask | Procedure or surgery | Supplemental oxygen |
| Sham room airRoom air applied via mask | Procedure or surgery | Sham room air |
Primary outcome
Work Rate (Watt)
Time frame: 1 day
Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air
Endurance Time (s) Endurance Time (s) Endurance Time (s)
Time frame: 1 day
Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air
5 secondary outcomes
Peak Oxygen uptake
Time frame: 1 day
Respiratory Exchange ratio
Time frame: 1 day
Changes in arterial blood parameters
Time frame: 1 day
muscle tissue oxygen
Time frame: 1 day
cerebral tissue oxygen
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen application in people with Grown-up Congenital Heart Disease (GUCH), run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Rate (Watt) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.