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Clinical Trials/NCT05684562
NCT05684562
Recruiting
Not Applicable

Pulmonary Determinants of Cardiorespiratory Fitness in Patients With Fontan Procedure

Hacettepe University1 site in 1 country78 target enrollmentDecember 26, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fontan Procedure
Sponsor
Hacettepe University
Enrollment
78
Locations
1
Primary Endpoint
FEV1/FVC
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study will examine and record the patient's medical information and medical records (patient files, computer records, etc.). Physical examination, echocardiographic, electrocardiographic, laboratory, radiological, etc. evaluations are made during the routine controls of the patients. Within the scope of this study, no attempt will be made on the patients, no additional tests will be performed, or treatment changes will not be made in the patients because they are included in this study. After these records, KPET will be performed by a specialist doctor and physiotherapist for the patients who are directed to the Faculty of Physical Therapy and Rehabilitation Cardiopulmonary Rehabilitation Unit. Pulmonary function tests and respiratory muscle strength measurements will be performed on patients who have adequate rest after CPET.

Registry
clinicaltrials.gov
Start Date
December 26, 2023
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Haluk TEKERLEK

Research assistant

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • Be between 8-55 years old
  • Having undergone a Fontan operation
  • Clinical stability of the patients (preserved ventricular function)
  • No change in ongoing drug therapy that adversely affects clinical stability
  • At least 1 year after the operation
  • Fontan Group

Exclusion Criteria

  • Neurological and/or genetic musculoskeletal disease
  • Having orthopedic and cognitive problems that prevent testing
  • The patient's and/or family's unwillingness to participate in the study
  • Control Group Inclusion Criteria:
  • Not have cardiovascular, neurological, and/or genetic musculoskeletal disease
  • Not having orthopedic and cognitive problems that prevent testing
  • The patient's and/or family's willingness to participate in the study

Outcomes

Primary Outcomes

FEV1/FVC

Time Frame: 15-20 minutes

Maximal inspiratory pressure

Time Frame: 15-20 minutes

Ratio curve of minute ventilation to carbon dioxide production (VE/VCO2) slope

Time Frame: 30-45 minutes

Ratio of minute ventilation to carbon dioxide production (VE/VCO2)

Time Frame: 30-45 minutes

Oxygen uptake efficiency slope (OUES)

Time Frame: 30-45 minutes

Maximal oxygen consumption

Time Frame: 30-45 minutes

Forced vital capacity (FVC)

Time Frame: 15-20 minutes

Forced expiratory volume in 1 second (FEV1)

Time Frame: 15-20 minutes

Maximal expiratory pressure

Time Frame: 15-20 minutes

Minute ventilation (VE)

Time Frame: 30-45 minutes

End tidal carbon dioxide pressure (PetCO2)

Time Frame: 30-45 minutes

End tidal oxygen pressure (PetO2)

Time Frame: 30-45 minutes

Study Sites (1)

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