Status:

COMPLETED

Inspiratory Muscle Therapy in Subjects With Fontan Circulations

Lead Sponsor:

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Conditions:

Single-ventricle

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory mechanics to support pulmonary blood flow (PBF). The investigators hypothesized that enhanced respiratory mu...

Detailed Description

Adult Fontan subjects were recruited from 2 academic medical centers. Following characterization of pulmonary function and functional class, CPET was performed using incremental and constant work rate...

Eligibility Criteria

Inclusion

  • Single ventricle physiology status post Fontan palliation

Exclusion

  • The presence of a sub-pulmonary ventricle
  • Pregnancy or any contraindication to stress testing (e.g., uncontrolled symptomatic arrhythmia, severe systemic ventricular outflow tract obstruction or uncontrolled symptomatic heart failure).
  • Height less than 4'11" due to limitations of the cycle ergometer.

Key Trial Info

Start Date :

January 29 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 31 2017

Estimated Enrollment :

7 Patients enrolled

Trial Details

Trial ID

NCT03339466

Start Date

January 29 2016

End Date

August 31 2017

Last Update

January 29 2024

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