Hemodynamic, Vascular and Muscular Parameters of Exercise Capacity in Single-Ventricle Patients With Fontan Procedure

NCT05011565 | Completed

• 1 other identifier: fontanexercisecapacity
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

After the Fontan procedure applied in patients with a functional or anatomical single ventricle, patients are faced with significant morbidity and mortality risk. Most of the common complications after Fontan such as arrhythmia, cyanosis, ventricular dysfunction, heart failure, atrioventricular valve insufficiency, protein-losing enteropathy, thrombosis, bleeding, venous insufficiency directly or indirectly limit exercise capacity. It has been reported that hemodynamic, vascular and muscular factors may be effective in the decrease of exercise capacity. In previous studies, it has been reported that cardiac output, one of the hemodynamic parameters, is the main factor affecting exercise capacity in patients with Fontan, and this is due to insufficient increase in stroke volume. In addition to the hemodynamic profile, the effects of muscle oxygenation, arterial stiffness and peripheral muscle strength on exercise capacity have been mentioned in different studies. For this reason, it is thought that examining the effects of hemodynamic, vascular and muscular profile together on submaximal and maximal exercise capacity in patients with Fontan will provide information about the mechanisms of influence of different exercise capacities and will provide important information in terms of determining exercise-based rehabilitation programs for such patients.

Conditions

Single-ventricle; Fontan Procedure; Hemodynamic Instability; Arterial Stiffness; Muscle Oxygenation; Exercise Capacity

Outcome Measures

Primary Outcomes (7)

• Maximal O2 consumption

  CPET, the gold standard for cardiorespiratory fitness, will be used in the assessment of maximal exercise capacity based on maximal O2 consumption . 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. The most commonly used method for KPET applied with a treadmill is the Bruce protocol. However, since the Bruce protocol prefers high workload preferences, the Modified Bruce/half Bruce protocol with intermediate increments will be used.

  30-45 minutes

• 6MWT distance

  Submaximal exercise capacity based on 6MWT distance will be assessed with the 6MWT. The standard test protocol will be applied in a continuous 30 meter corridor. The patient wearing comfortable clothes and shoes will be given standard instructions and verbal guidance during the test. The distance the patient walked during the test will be recorded in meters.

  15-20 minutes

• Cardiac output (Q)

  Hemodynamic findings will be evaluated by a specialist doctor with Speckle Tracking Echocardiography. During the evaluation, standard echocardiographic measurements will be performed with transthoracic echocardiography. With these measurements, images suitable for strain analysis will be taken. For the appropriate images taken, deformation analysis will be made using the speckle traking method. The hemodynamic parameters obtained by the analysis will be recorded.

  30-45 minutes

• Stroke volume (SV)

  Hemodynamic findings will be evaluated by a specialist doctor with Speckle Tracking Echocardiography. During the evaluation, standard echocardiographic measurements will be performed with transthoracic echocardiography. With these measurements, images suitable for strain analysis will be taken. For the appropriate images taken, deformation analysis will be made using the speckle traking method. The hemodynamic parameters obtained by the analysis will be recorded.

  30-45 minutes

• Upper and lower extremity muscle strength

  Upper extremity muscle strength will be measured using a hand grip strength hand dynamometer (Jamar, Sammons Preston, Rolyon, Bolingbrook, IL, USA). Measurements shall be made using standard procedures, right and left sides, with the arms at the side of the trunk, the elbow in a 90 degree flexion position, and the forearm and wrist in a neutral position. The highest of the three measurements will be considered as hand grip strength. For lower extremity muscle strength, the maximum isometric muscle strength of the Quadriceps femoris muscle will be measured with a dynamometer (Lafayette Instrument Company, Lafayette, Indiana).

  15-20 minutes

• Muscle oxygen saturation (SmO2)

  Muscle oxygenation will be measured during CPET and 6MWT. Muscle oxygenation will be assessed with the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA), a device that measures local oxygen saturation (SmO2) in muscle capillaries using near infrared spectroscopy (NIRS). During the tests, Moxy will be placed on the vastus lateralis muscle of the participant's dominant leg, midway between the greater trochanter and lateral epicondyle of the femur. After five minutes of sitting resting, SmO2 and THb will be recorded as resting data. During the test, the Moxy data will be recorded continuously and the average value of the recorded data from the beginning to the last moment of the test will be recorded.

  30-45 minutes

• Arterial stiffness

  Vascular function will be evaluated using the aortic pulse wave velocity (PWV) technique. During measurement, the Echo probe will be placed in the suprasternal notch, while a pulse Doppler collecting probe will be placed at the Aortic isthmus level and Doppler velocity tracking will be recorded. The time (T1) between the peak of the R wave on the electrocardiogram and the onset of aortic flow on the Doppler will be measured. The Doppler velocity tracking will then be recorded and the time (T2) between the peak R wave (time reference) and the start of the Doppler flow will be measured. T2-T1 is the time between the aortic isthmus of the pulse wave and the accepted point of the abdominal aorta. The distance between the two points (D2 and D1) where the probes are placed will be given by the difference between D2 and D1. PWV will be calculated with the formula D2-D1/T2-T1.

  30-45 minutes

Study Arms (2)

Fontan Group

Fontan Group Inclusion Criteria * be between the ages of 8-50 * Having undergone Fontan operation in our hospital or another center * 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 and to be followed in the Pediatric Cardiology Polyclinic of our hospital Fontan Group Exclusion Criteria: * Inability to access the patient's medical data * 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

Other: Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function

Control Group

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

Other: Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function

Interventions

Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function OTHER

Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function

Control Group; Fontan Group

Eligibility Criteria

• Age: 8 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

After obtaining informed consent, control cases will also be evaluated in terms of evaluation parameters within the scope of the study. Patients aged 8-50 years who underwent the fonton procedure and were followed by Hacettepe University, Department of Pediatric Cardiology will be included in the study. A medical and family history, and a physical examination focused on all systems, especially cardiovascular and musculoskeletal systems, will be essential. The eligible patients will be referred to Faculty of Physical Therapy and Rehabilitation after the routine evaluations are completed. Control cases planned to be included in the study to be compared with the results of Fontan patients will be created by inviting the healthy relatives of the patients who applied to our faculty to participate in the study. In addition, control cases will be invited to work through an online advertisement.

You may qualify if:

• be between the ages of 8-50
• Having undergone Fontan operation in our hospital or another center
• 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 and to be followed in the Pediatric Cardiology Polyclinic of our hospital

You may not qualify if:

• Inability to access the patient's medical data
• 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 University

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• Cordina R, O'Meagher S, Gould H, Rae C, Kemp G, Pasco JA, Celermajer DS, Singh N. Skeletal muscle abnormalities and exercise capacity in adults with a Fontan circulation. Heart. 2013 Oct;99(20):1530-4. doi: 10.1136/heartjnl-2013-304249. Epub 2013 Jul 11.

  PMID: 23846614 BACKGROUND

• Goldstein BH, Urbina EM, Khoury PR, Gao Z, Amos MA, Mays WA, Redington AN, Marino BS. Endothelial Function and Arterial Stiffness Relate to Functional Outcomes in Adolescent and Young Adult Fontan Survivors. J Am Heart Assoc. 2016 Sep 24;5(9):e004258. doi: 10.1161/JAHA.116.004258.

  PMID: 27664807 BACKGROUND

• Legendre A, Guillot A, Ladouceur M, Bonnet D. Usefulness of stroke volume monitoring during upright ramp incremental cycle exercise in young patients with Fontan circulation. Int J Cardiol. 2017 Jan 15;227:625-630. doi: 10.1016/j.ijcard.2016.10.087. Epub 2016 Oct 29.

  PMID: 27810293 BACKGROUND

• Tekerlek H, Aykan HH, Vardar-Yagli N, Selcuk SN, Basol-Goksuluk M, Karagoz T, Saglam M. Predictive Role of Atrial Strain, Aortic Stiffness, and Muscle-Related Factors for Maximal and Submaximal Exercise Capacity in Fontan Patients. Pediatr Cardiol. 2025 Dec;46(8):2443-2455. doi: 10.1007/s00246-024-03687-3. Epub 2024 Oct 29.

  PMID: 39470752 DERIVED

MeSH Terms

Conditions

Univentricular Heart

Interventions

Demography; Muscle Strength

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 18, 2021
• Study Start: January 20, 2021
• Primary Completion: November 14, 2022
• Study Completion: April 14, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)