NCT04076501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

September 12, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

August 30, 2019

Last Update Submit

April 16, 2021

Conditions

Grown-up Congenital Heart Disease (GUCH)

Outcome Measures

Primary Outcomes (2)

  • Work Rate (Watt)

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

    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

    1 day

Secondary Outcomes (5)

  • Peak Oxygen uptake

    1 day

  • Respiratory Exchange ratio

    1 day

  • Changes in arterial blood parameters

    1 day

  • muscle tissue oxygen

    1 day

  • cerebral tissue oxygen

    1 day

Study Arms (2)

Supplemental oxygen

EXPERIMENTAL

Supplemental oxygen will be applied via a mask during CPET

Procedure: Oxygen application

Sham room air

SHAM COMPARATOR

Room air will be applied similarly to oxygen

Procedure: Sham room air

Interventions

Oxygen applicationPROCEDURE

Oxygen application Supplemental oxygen via mask

Supplemental oxygen
Sham room airPROCEDURE

Room air applied via mask

Sham room air

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • GUCH, stable medication for at least 4 weeks.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Pneumology

Zurich, , 8091, Switzerland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 3, 2019

Study Start

September 12, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)