NCT02661802

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

January 20, 2016

Last Update Submit

January 22, 2016

Conditions

Eisenmenger ComplexHypertension, Pulmonary

Outcome Measures

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.

    At enrollment

Study Arms (1)

Oxygen Supplementation

EXPERIMENTAL

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

Oxygen SupplementationOTHER

Oxygen delivery was continuous by mask at 40%

Oxygen Supplementation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Lung, liver or connective tissue diseases
  • Neuromuscular diseases
  • Inability to perform a pulmonary function test and/or chronic lung disease
  • Inability to walk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Eisenmenger ComplexHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLung DiseasesRespiratory Tract DiseasesHypertensionVascular Diseases

Study Officials

  • Laion Gonzaga, PT

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 22, 2016

Study Start

January 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 25, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

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.