Effect of Short-term Oxygen During CPET in GUCH

NCT ID: NCT04076501

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-12

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Grown-up Congenital Heart Disease (GUCH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Supplemental oxygen

Supplemental oxygen will be applied via a mask during CPET

Group Type EXPERIMENTAL

Oxygen application

Intervention Type PROCEDURE

Oxygen application Supplemental oxygen via mask

Sham room air

Room air will be applied similarly to oxygen

Group Type SHAM_COMPARATOR

Sham room air

Intervention Type PROCEDURE

Room air applied via mask

Interventions

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Oxygen application

Oxygen application Supplemental oxygen via mask

Intervention Type PROCEDURE

Sham room air

Room air applied via mask

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Zurich, Division of Pneumology

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-NR. 2012-0251_4

Identifier Type: -

Identifier Source: org_study_id

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