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CompletedNCT02661802Updated Jan 25, 2016

Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome

An interventional study of Oxygen Supplementation in Eisenmenger Complex and Hypertension, Pulmonary, sponsored by Federal University of São Paulo. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-01-25.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed 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.

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Conditions studied

  • Eisenmenger Complex
  • Hypertension, Pulmonary
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In context

Eisenmenger Complex

23 studies on the registry are indexed under Eisenmenger Complex; 5 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 15 interventional studies indexed under Eisenmenger Complex.

Browse Eisenmenger Complex studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 439 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Abscence of heart failure and/or respiratory infection
  • Advanced therapy for pulmonary hypertension

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Oxygen Supplementation

    Two six-minute walk tests, one with oxygen supplementation and another without were performed on different days. During the test with oxygen supplementation the delivery was continuous by mask at 40% and technician walked behind the patient with the oxygen source.

    Other: Oxygen Supplementation

Interventions

  • OtherOxygen Supplementation

    Oxygen delivery was continuous by mask at 40%

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: At enrollment

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — No participant data will be shared. However, all enrolled subjects were provided the principal investigator's phone number and e-mail address in order to receive test results and ask questions.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02661802
Responsible party
Laion rodrigo do Amaral Gonzaga (Principal Investigator, Federal University of São Paulo) — Principal investigator
First posted
Jan 22, 2016
Start date
Jan 2012
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Jan 25, 2016

Study contacts

Laion Gonzaga, PT
principal investigator · Federal University of São Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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