Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome

Hypertension, Pulmonary Clinical Trial

Official title:

Acute Effects of 40% Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661802
• Other study ID #: 13473813.1.0000.5505
• Status: Completed
• Phase: N/A
• First received: January 20, 2016
• Last updated: January 22, 2016
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the acute effects of oxygen supplementation during a submaximal exercise test in patients with Eisenmenger's Syndrome.

Description:

Patients with Eisenmenger's syndrome were submitted to a submaximal exercise test (six-minute walking test) with and without supplemental oxygen. The distance walked during the two tests were compared to assess the impact of oxygen supplementation on the walking distance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Eisenmenger Complex
• Hypertension, Pulmonary

Intervention

Other:
• Oxygen Supplementation
Oxygen delivery was continuous by mask at 40%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance walked during the six-minute walk tests	Distance walked during the six-minute walk tests with and without oxygen supplementation were recorded and compared to each other to establish the impact of the intervention.	At enrollment	Yes