Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients

Congenital Heart Disease Clinical Trial

Official title:

Pulmonary Determinants of Cardiorespiratory Fitness in Patients With Fontan Procedure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05684562
• Other study ID #: fontanpulmonarydeterminants
• Status: Recruiting
• Start date: December 26, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: Haluk Tekerlek
• Phone: +905355915009
• Email: haluktekerlek[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 30, 2024
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Fontan Procedure
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Cardiopulmonary exercise 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 test
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
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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen consumption		30-45 minutes
Primary	Forced vital capacity (FVC)		15-20 minutes
Primary	Forced expiratory volume in 1 second (FEV1)		15-20 minutes
Primary	FEV1/FVC		15-20 minutes
Primary	Maximal inspiratory pressure		15-20 minutes
Primary	Maximal expiratory pressure		15-20 minutes
Primary	Ratio curve of minute ventilation to carbon dioxide production (VE/VCO2) slope		30-45 minutes
Primary	Ratio of minute ventilation to carbon dioxide production (VE/VCO2)		30-45 minutes
Primary	Oxygen uptake efficiency slope (OUES)		30-45 minutes
Primary	Minute ventilation (VE)		30-45 minutes
Primary	End tidal oxygen pressure (PetO2)		30-45 minutes
Primary	End tidal carbon dioxide pressure (PetCO2)		30-45 minutes