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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 February 2016
Main ID:  NCT02661802
Date of registration: 20/01/2016
Prospective Registration: No
Primary sponsor: Federal University of São Paulo
Public title: Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome
Scientific title: Acute Effects of 40% Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome
Date of first enrolment: January 2012
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02661802
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care  
Phase:  N/A
Countries of recruitment
Contacts
Name:     Laion Gonzaga, PT
Address: 
Telephone:
Email:
Affiliation:  Federal University of Sao Paulo
Key inclusion & exclusion criteria

Inclusion Criteria:

- Abscence of heart failure and/or respiratory infection

- Advanced therapy for pulmonary hypertension

Exclusion Criteria:

- Lung, liver or connective tissue diseases

- Neuromuscular diseases

- Inability to perform a pulmonary function test and/or chronic lung disease

- Inability to walk



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Hypertension, Pulmonary
Eisenmenger Complex
Intervention(s)
Other: Oxygen Supplementation
Primary Outcome(s)
Distance walked during the six-minute walk tests [Time Frame: At enrollment]
Secondary Outcome(s)
Secondary ID(s)
13473813.1.0000.5505
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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