Effect of Short-term Oxygen During CPET in GUCH

April 16, 2021 updated by: University of Zurich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, , 8091
        • University Hospital Zurich, Division of Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Supplemental oxygen
Supplemental oxygen will be applied via a mask during CPET
Procedure: Oxygen application
Oxygen application Supplemental oxygen via mask
SHAM_COMPARATOR: Sham room air
Room air will be applied similarly to oxygen
Procedure: Sham room air
Room air applied via mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work Rate (Watt)
Time Frame: 1 day
Maximal Work Rate (Wmax) measured during cardiopulmonary exercise test oxygen vs. room air
1 day
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
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 12, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

August 30, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (ACTUAL)

September 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-NR. 2012-0251_4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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