Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients

NCT05684562 | Recruiting

• 1 other identifier: fontanpulmonarydeterminants
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Fontan Procedure; Congenital Heart Disease

Outcome Measures

Primary Outcomes (12)

• Maximal oxygen consumption

  30-45 minutes

• Forced vital capacity (FVC)

  15-20 minutes

• Forced expiratory volume in 1 second (FEV1)

  15-20 minutes

• FEV1/FVC

  15-20 minutes

• Maximal inspiratory pressure

  15-20 minutes

• Maximal expiratory pressure

  15-20 minutes

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

  30-45 minutes

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

  30-45 minutes

• Oxygen uptake efficiency slope (OUES)

  30-45 minutes

• Minute ventilation (VE)

  30-45 minutes

• End tidal oxygen pressure (PetO2)

  30-45 minutes

• End tidal carbon dioxide pressure (PetCO2)

  30-45 minutes

Study Arms (2)

Fontan group

Cardiopulmonary exercise test Pulmonary function test respiratory muscle strength test

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

Other: Cardiopulmonary exercise test; Other: Pulmonary function test; Other: Respiratory muscle strength test

Interventions

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.

Control Group; Fontan group

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.

Control Group; Fontan group

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.

Control Group; Fontan group

Eligibility Criteria

• Age: 8 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe Unıversity

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Exercise Test; Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Haluk Tekerlek

CONTACT

+905355915009; haluktekerlek@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 13, 2023
• Study Start: December 26, 2023
• Primary Completion: December 25, 2024
• Study Completion: December 30, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)