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

March 20, 2024 updated by: Haluk TEKERLEK, Hacettepe University

The Effects of Hemodynamic, Vascular and Muscular Parameters on Maximal and Submaximal Exercise Capacity in Single-Ventricle Patients With the Fontan Procedure

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Fontan operation is a palliative surgical procedure performed in patients with a functional or anatomical single ventricle. After the Fontan procedure, patients face significant risk of morbidity and mortality, and patients with complicated congenital heart disease need to be followed for life by a cardiologist experienced in the care of patients. Annual follow-up is recommended in uncomplicated patients, but more frequent follow-up is required in patients with postoperative complications. Survival rates of 15-20 years after the operation vary between 60-85%. Since there is no ventricular pump to push blood into the pulmonary artery circulation in patients undergoing the Fontan procedure, there is increased systemic venous pressure compared to normal biventricular circulation. Most of the common complications after Fontan are directly or indirectly related to elevation of central venous pressure. These complications include arrhythmia, cyanosis, decreased exercise capacity, ventricular dysfunction, heart failure, atrioventricular valve insufficiency, protein-losing enteropathy, thrombosis, bleeding, venous insufficiency. Patients undergoing the Fontan procedure generally do not experience a normal increase in cardiac output during exercise; therefore exercise capacity is limited. It has been emphasized that hemodynamic, vascular and muscular factors may be effective in decreasing exercise capacity. In previous studies, it has been reported that cardiac output is the main factor affecting exercise capacity in patients with Fontan, and this is due to insufficient increase in stroke volume. However, in previous studies, it has been reported that factors such as insufficient precision of measurements (resting echocardiography in supine position, resting cardiac MRI) and failure to see optimal functions with maximum effort are insufficient to interpret the effects of hemodynamic profile on exercise capacity. Therefore, it is important to evaluate the global and regional myocardial functions in more detail and to determine the hemodynamic profile with speckle tracking echocardiography. In a study, it was reported that atrial tension parameters measured by speckle tracking echocardiography in the Fontan circulation were affected and this was related to functional exercise capacity.. In addition to the hemodynamic profile, the effects of muscle oxygenation, arterial stiffness and peripheral muscle strength on exercise capacity were also mentioned in some separate studies. Changes in muscle oxygenation in children undergoing the Fontan procedure indicate that the balance between the oxygen demand of the tissues and the amount of oxygen supplied is impaired. It is thought that this may be a mechanism that causes a decrease in exercise tolerance in this patient population. Also, the function of peripheral muscles by acting as a pump is particularly important for venous return in the Fontan circulation, and skeletal muscle mass is reduced in patients with Fontan. Studies have shown that leg lean mass is closely related to an increase in blood flow during exercise, and skeletal muscle contractions can generate pulsatile pulmonary blood flow in some patients with Fontan circulation. A relationship was also found between arterial stiffness and cardiorespiratory fitness in pediatric and adult patients with fontan circulation, and it has been reported that practices to increase exercise capacity may be important for the preservation of vascular structures. Exercise capacity in children and adults undergoing the Fontan procedure is evaluated with field tests such as the cardiopulmonary exercise test (CPET) and the 6-minute walk test (6MWT). CPET is very important in terms of providing objective data in terms of cardiopulmonary fitness in the evaluation of maximal exercise capacity and being the gold standard. However, in terms of determining the functional levels of individuals and maintaining their daily living activities, submaximal exercise capacity, which is evaluated with both cheap and practical 6MWT, also gains importance. When the literature was searched, there was no study examining the effects of hemodynamic, vascular and muscular profile on submaximal and maximal exercise capacity. Therefore, in this study, it is aimed to determine and compare the effects of hemodynamics, arterial stiffness and muscle oxygenation on maximal and submaximal exercise capacity in patients with single ventricle who underwent Fontan procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal O2 consumption
Time Frame: 30-45 minutes
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
Time Frame: 15-20 minutes
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)
Time Frame: 30-45 minutes
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)
Time Frame: 30-45 minutes
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
Time Frame: 15-20 minutes
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)
Time Frame: 30-45 minutes
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
Time Frame: 30-45 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • fontanexercisecapacity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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