An observational study in Fontan Procedure and Congenital Heart Disease, sponsored by Hacettepe University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Hacettepe University · Observational
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Among 32 studies in Heart Defects, Congenital with a site in Turkey — 11 open to participants now, 12 under way, none of them phase 3. Heart Defects, Congenital · Turkey.
Among the 32 studies in Heart Defects, Congenital with a site in Turkey, this one is the 6th largest by planned enrollment of the 14 observational ones that give a count, is one of 3 that started in 2023, is one of 14 observational ones, reaches primary completion later than 5 of the 11 other live ones, and was the 14th registered.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
Browse Heart Defects, Congenital studies →11 of the 32 studies in Heart Defects, Congenital with a site in Turkey are open now. Recruiting first, the newest first:
Baskent University · Sites in Turkey
Ages 2 mo–12 mo
Fondation Hôpital Saint-Joseph · Sites in Turkey, Denmark, Egypt and 14 more countries
Ages 1 mo+
Ankara Yildirim Beyazıt University · Sites in Turkey
Ages 16–20
Occlutech International AB · Sites in Turkey, Ireland, United Kingdom
Ages 3 mo–80 yrs
Izmir Democracy University · Sites in Turkey
Ages 8–18
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 154 Heart Defects, Congenital studies recruiting now, 67 (44%) set no upper age limit and 79 (51%) stop at 75 or younger; 110 take children under 18; 25 take healthy volunteers.
This study: 8 Years to 55 Years · all sexes · healthy volunteers too.
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32 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 78 is below the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Median enrollment 51 across the 18 interventional studies, 71 across the 14 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
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1 of 32 have an industry lead sponsor. The 10 most frequent:
Hacettepe University is the lead sponsor of 1,009 studies on the registry; 214 are open to participants now.
Hacettepe University has 7 studies filed under Heart Defects, Congenital — fewer than ten, so there is no comparison to draw.
5 of the studies in Heart Defects, Congenital with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05684562Hacettepe UniversityPulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients | 2026-12-25 |
| NCT06823635Fondation Hôpital Saint-JosephAn International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects | 2026-12-31 |
| NCT07564882Baskent UniversityThe Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters | 2027-04-30 |
| NCT07575451Cukurova UniversityEmpowering Families in Pediatric Cardiovascular Surgery: A RAM-Based Approach | 2027-06-15 |
| NCT07319858Istanbul University - CerrahpasaThe Effect of Using Multifunctional Baby Carrier With Heart Surgery | 2027-08 |
Add all 5 to your calendar (.ics) → With an account.
Among the 32 studies in Heart Defects, Congenital with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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:
Fontan Group Exclusion Criteria:
Control Group Inclusion Criteria:
Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
Other: Cardiopulmonary exercise test · Other: Pulmonary function test · Other: Respiratory muscle strength test
Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test
Other: Cardiopulmonary exercise test · Other: Pulmonary function test · Other: Respiratory muscle strength test
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 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.
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.
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
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Dec 2026, 35 months after the start.
Of 178 non-industry observational studies under Heart Defects, Congenital, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 83. This study's planned 35 months is below that.
Counting every sponsor, half of 185 studies reached it within 44 months; a quarter within 17 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
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