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NCT Number: NCT05684562

Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients

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.

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Key information

Conditions

Fontan Procedure Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

8 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Fontan Group 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

Treatment and study plan

Cardiopulmonary exercise test

Other

CPET, the gold standard, will be used in the assessment of cardiorespiratory fitness. The cardiopulmonary exercise test system (Cosmed Quark CPET, Rome, Italy) is a safe method in which the patient can be monitored via ECG during the execution of the individual on a treadmill, and simultaneously lactate measurement, maximal O2 consumption, and CO2 production are evaluated. The Bruce protocol is the most commonly used method for KPET applied with a treadmill. However, since the Bruce protocol prefers high workload preferences, the Modified Bruce/half Bruce protocol with intermediate increments will be used. In addition, dyspnea, leg fatigue, and general fatigue at rest, during the test, and during the recovery phases after the test will be recorded with a sphygmomanometer using the Modified Borg Scale.

pulmonary function test

Other

Pulmonary function testing will be performed with a spirometer (Cosmed Quark CPET, Rome, Italy) connected to the CPET system using standard procedures. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC, peak expiratory volume measured at 25% and 75% of forced expiratory time (FEF 25-75%), and peak expiratory volume (PEF) parameters will be saved.

Respiratory muscle strength test

Other

Intraoral maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) will be used as indicators of respiratory muscle strength. A portable intraoral pressure gauge (MicroRPM, Micromedical, Kent, UK) and nose clip will be used during MIP and MEP assessments. MIP and MEP measurements will be obtained using standard procedures. 3 measurements will be made where the difference between each measurement is not more than 10% and the maximum value of MIP and MEP will be recorded.

Primary outcomes

  1. Maximal oxygen consumption

    Time frame: 30-45 minutes

  2. Forced vital capacity (FVC)

    Time frame: 15-20 minutes

  3. Forced expiratory volume in 1 second (FEV1)

    Time frame: 15-20 minutes

  4. FEV1/FVC

    Time frame: 15-20 minutes

  5. Maximal inspiratory pressure

    Time frame: 15-20 minutes

  6. Maximal expiratory pressure

    Time frame: 15-20 minutes

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

    Time frame: 30-45 minutes

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

    Time frame: 30-45 minutes

  9. Oxygen uptake efficiency slope (OUES)

    Time frame: 30-45 minutes

  10. Minute ventilation (VE)

    Time frame: 30-45 minutes

  11. End tidal oxygen pressure (PetO2)

    Time frame: 30-45 minutes

  12. End tidal carbon dioxide pressure (PetCO2)

    Time frame: 30-45 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Haluk Tekerlek

CONTACT

[email protected]

+905355915009

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Pulmonary Determinants of Cardiorespiratory Fitness in Patients With Fontan Procedure

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2023
Registry last updated
Sep 16, 2026

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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