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Completed

NCT Number: NCT02661802

Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome

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.

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Key information

Conditions

Eisenmenger Complex Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen Supplementation

Other

Oxygen delivery was continuous by mask at 40%

Primary outcomes

  1. Distance walked during the six-minute walk tests

    Time frame: At enrollment

    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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 22, 2016
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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