Fontan ProcedureNCT05684562
Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients
An observational study of Fontan Procedure and Congenital Heart Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fontan Procedure, Congenital Heart Disease
- What is being tested?
- Cardiopulmonary exercise test, Pulmonary function test and Respiratory muscle strength test
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2023to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients aged 8-55 years who underwent the Fontan procedure and followed up by Department of Pediatric Cardiology will be included in the study. In the evaluation of patients in terms of suitability for the study, a detailed history, medical and family history, and a physical examination focused on all systems. The eligible patients will be referred to the Cardiopulmonary Rehabilitation Unit after the routine evaluations including demographic and clinical characteristics and laboratory tests are completed. For patients aged 8-17 years, the parental informed consent form for the research study and the child consent form for the research study will be carefully explained and included in the study after the parents and patients have read, understood, and accepted. For patients aged 18 years and older, the informed consent form for the research study will be carefully explained and will be included in the study after the patients have read, understood, and accepted.
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe Unıversity
Ankara
Haluk Tekerlek, +905355915009, haluktekerlek@gmail.com
Haluk Tekerlek, haluktekerlek@gmail.com
About this study
Official title: Pulmonary Determinants of Cardiorespiratory Fitness in Patients With Fontan Procedure
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.
- Conditions
- Fontan Procedure, Congenital Heart Disease
- Being tested
- Cardiopulmonary exercise test, Pulmonary function test, Respiratory muscle strength test
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testOther
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 testOther
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 testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fontan group | Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test Receives: Other: Cardiopulmonary exercise test; Other: Pulmonary function test; Other: Respiratory muscle strength test | |
| Control Group | Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test Receives: Other: Cardiopulmonary exercise test; Other: Pulmonary function test; Other: Respiratory muscle strength test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption
Measured: 30-45 minutes
Forced vital capacity (FVC)
Measured: 15-20 minutes
Forced expiratory volume in 1 second (FEV1)
Measured: 15-20 minutes
FEV1/FVC
Measured: 15-20 minutes
Maximal inspiratory pressure
Measured: 15-20 minutes
Maximal expiratory pressure
Measured: 15-20 minutes
Ratio curve of minute ventilation to carbon dioxide production (VE/VCO2) slope
Measured: 30-45 minutes
Ratio of minute ventilation to carbon dioxide production (VE/VCO2)
Measured: 30-45 minutes
Oxygen uptake efficiency slope (OUES)
Measured: 30-45 minutes
Minute ventilation (VE)
Measured: 30-45 minutes
End tidal oxygen pressure (PetO2)
Measured: 30-45 minutes
End tidal carbon dioxide pressure (PetCO2)
Measured: 30-45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start26 Dec 2023
- Primary completion25 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fontan ProcedureStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haluk TEKERLEK, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684562
- Sponsor's protocol ID
- fontanpulmonarydeterminants
- Status last verified
- Sep 2026
- First submitted
- 27 Dec 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Determinants of Cardiorespiratory Fitness in Patients With Fontan Procedure
- ClinicalTrials.gov ID
- NCT05684562
- Acronym / sponsor ID
- fontanpulmonarydeterminants
- Conditions
- Fontan Procedure, Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fontan group | – | Other: Cardiopulmonary exercise test, Other: Pulmonary function test, Other: Respiratory muscle strength testCardiopulmonary exercise test Pulmonary function test respiratory muscle strength test |
| Control Group | – | Other: Cardiopulmonary exercise test, Other: Pulmonary function test, Other: Respiratory muscle strength testCardiopulmonary exercise test Pulmonary function test respiratory muscle strength test |
Who may qualify
- Ages
- 8 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 8-55 years who underwent the Fontan procedure and followed up by Department of Pediatric Cardiology will be included in the study. In the evaluation of patients in terms of suitability for the study, a detailed history, medical and family history, and a physical examination focused on all systems. The eligible patients will be referred to the Cardiopulmonary Rehabilitation Unit after the routine evaluations including demographic and clinical characteristics and laboratory tests are completed. For patients aged 8-17 years, the parental informed consent form for the research study and the child consent form for the research study will be carefully explained and included in the study after the parents and patients have read, understood, and accepted. For patients aged 18 years and older, the informed consent form for the research study will be carefully explained and will be included in the study after the patients have read, understood, and accepted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testCPET, 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. | Other | Control Group, Fontan group |
| Pulmonary function testPulmonary 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. | Other | Control Group, Fontan group |
| Respiratory muscle strength testIntraoral 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. | Other | Control Group, Fontan group |
Primary outcome
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
FEV1/FVC
Time frame: 15-20 minutes
Maximal inspiratory pressure
Time frame: 15-20 minutes
Maximal expiratory 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
Minute ventilation (VE)
Time frame: 30-45 minutes
End tidal oxygen pressure (PetO2)
Time frame: 30-45 minutes
End tidal carbon dioxide pressure (PetCO2)
Time frame: 30-45 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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The Effect of Dapagliflozin on Exercise and Cardiac Functional Status of Patients After Fontan Procedure
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Active, not recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fontan Procedure and Congenital Heart Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haluk Tekerlek (+905355915009, haluktekerlek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen consumption (time frame: 30-45 minutes). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.