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Clinical Trials/NCT04076501
NCT04076501
Completed
Not Applicable

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

University of Zurich1 site in 1 country7 target enrollmentSeptember 12, 2019
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ConditionsGrown-up Congenital Heart Disease (GUCH)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Grown-up Congenital Heart Disease (GUCH)
Sponsor
University of Zurich
Enrollment
7
Locations
1
Primary Endpoint
Endurance Time (s) Endurance Time (s) Endurance Time (s)
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2019
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Work Rate (Watt)

Time Frame: 1 day

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

Secondary Outcomes

  • Respiratory Exchange ratio(1 day)
  • Peak Oxygen uptake(1 day)
  • Changes in arterial blood parameters(1 day)
  • muscle tissue oxygen(1 day)
  • cerebral tissue oxygen(1 day)

Study Sites (1)

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