Fontan ProcedureNCT07874165
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
An observational study of Fontan Procedure and Fontan Circulation, run by Universidad de Murcia.
Trial summary
This is a multicenter, observational, cross-sectional study designed to investigate whether a parsimonious set of low-cost, accessible functional, anthropometric, and physiological measurements can help identify multisystem clinical-physiological impairment in patients with Fontan circulation. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Fontan Procedure, Fontan Circulation
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to Jan 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population undergoing the Fontan procedure residing in Spain
Who may be able to join
- Patients who meet the following criteria will be eligible to participate in the study: having undergone Fontan surgery at least 2 years prior to enrollment; being between 14 and 60 years of age; be under stable outpatient follow-up by the corresponding clinical unit; and voluntarily agree to participate by signing an informed consent form after having been informed verbally and in writing about the objectives, procedures, risks, and potential benefits of this study. For participants who are minors, consent from their legal guardians and the minor's assent will be requested when appropriate.
Who cannot join
- Patients with an unstable outpatient clinical condition will be excluded, including those scheduled for reoperation or an invasive procedure within 3 months of the evaluation; patients in NYHA functional class IV (symptoms of heart failure even at rest and an inability to perform any physical activity without discomfort. Even minimal exertion may increase dyspnea, fatigue, or palpitations); the presence of physical, neuromuscular, orthopedic, or functional limitations that prevent the safe performance of the motor tasks required for the squat jump or for standing up from a chair; pregnancy; or refusal to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation
This is a multicenter, observational, cross-sectional study designed to investigate whether a parsimonious set of low-cost, accessible functional, anthropometric, and physiological measurements can help identify multisystem clinical-physiological impairment in patients with Fontan circulation.
Fontan circulation is associated with long-term multisystem complications affecting cardiac, cardiopulmonary, hepatic, renal, nutritional-lymphatic, hematological, and metabolic function. Current surveillance may require multiple specialized, costly, and time-consuming investigations. This study will explore whether simple and easily repeatable measurements can provide an accessible complementary approach for the initial functional and clinical assessment of these patients.
Read more
Approximately 150 participants aged 14 to 60 years with Fontan circulation, recruited from 18 Spanish healthcare centers, will be included. Participants must have undergone Fontan surgery at least 2 years before inclusion and be clinically stable in outpatient follow-up.
Each participant will attend one study-specific visit lasting approximately 45-60 minutes. During this visit, functional, anthropometric, and physiological variables will be assessed. Functional measurements will include squat jump performance using the Samozino method and the five-times sit-to-stand test (5xSTS) using the Alcázar method. Anthropometric measurements will include body mass index, age- and sex-adjusted anthropometric indicators of muscularity, and calf and thigh circumferences. Physiological measurements will include resting heart rate and oxygen saturation, heart rate recovery after the 1-minute sit-to-stand test, and post-exercise oxygen saturation.
Clinical, laboratory, echocardiographic, and functional data obtained as part of routine clinical follow-up will also be collected. Whenever possible, routine clinical measurements will correspond to assessments performed on the same day as the functional evaluation; measurements obtained within a maximum window of ±15 days will also be considered.
The primary analysis will evaluate the association between the candidate low-cost measurements and the presence of clinical-physiological impairment affecting two or more organ or functional domains. Additional analyses will investigate their ability to identify patients with impairment in at least one domain and to discriminate increasing levels of multisystem clinical-physiological burden.
The study will not involve any therapeutic intervention or prospective study-specific follow-up. The results will be interpreted as cross-sectional associations and will not establish causal or longitudinal prognostic relationships.
- Conditions
- Fontan Procedure, Fontan Circulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multisystem clinical-physiological impairment affecting ≥2 domains
Presence of clinical-physiological impairment affecting two or more predefined domains, based on clinical, laboratory, echocardiographic and functional variables obtained during routine follow-up. The domains include cardiopulmonary, cardiac, hepatic, renal, nutritional-lymphatic, and hematological-metabolic domains.
Measured: At the study assessment / cross-sectional assessment (single study visit)
Secondary outcomes (4)
Clinical-physiological impairment affecting ≥1 domain
Presence of impairment in at least one predefined clinical-physiological domain.
Measured: At the study assessment / cross-sectional assessment
Multisystem clinical-physiological burden
Ordinal level of clinical-physiological burden according to the number of affected domains: 0, 1, 2, or ≥3 domains.
Measured: At the study assessment / cross-sectional assessment
Discriminative capacity of low-cost functional, anthropometric and physiological variables
Ability of the candidate low-cost variables to discriminate participants according to the presence and degree of clinical-physiological impairment, assessed using AUC, sensitivity, specificity and predictive values.
Measured: At the study assessment / cross-sectional assessment
Association between candidate low-cost variables and clinical-physiological impairment
Association of functional, anthropometric and physiological variables with the presence of multisystem impairment. Candidate variables include squat jump parameters, 5xSTS performance, anthropometric measures, resting heart rate, oxygen saturation, heart-rate recovery after 1-minute sit-to-stand and post-exercise oxygen saturation.
Measured: At the study assessment / cross-sectional assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fontan ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Serrano Aguilar, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874165
- Sponsor's protocol ID
- 2026-7-5-HCUVA
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation
- ClinicalTrials.gov ID
- NCT07874165
- Acronym / sponsor ID
- 2026-7-5-HCUVA
- Conditions
- Fontan Procedure, Fontan Circulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, observational, cross-sectional study designed to investigate whether a parsimonious set of low-cost, accessible functional, anthropometric, and physiological measurements can help identify multisystem clinical-physiological impairment in patients with Fontan circulation.
Fontan circulation is associated with long-term multisystem complications affecting cardiac, cardiopulmonary, hepatic, renal, nutritional-lymphatic, hematological, and metabolic function. Current surveillance may require multiple specialized, costly, and time-consuming investigations. This study will explore whether simple and easily repeatable measurements can provide an accessible complementary approach for the initial functional and clinical assessment of these patients.
Approximately 150 participants aged 14 to 60 years with Fontan circulation, recruited from 18 Spanish healthcare centers, will be included. Participants must have undergone Fontan surgery at least 2 years before inclusion and be clinically stable in outpatient follow-up.
Each participant will attend one study-specific visit lasting approximately 45-60 minutes. During this visit, functional, anthropometric, and physiological variables will be assessed. Functional measurements will include squat jump performance using the Samozino method and the five-times sit-to-stand test (5xSTS) using the Alcázar method. Anthropometric measurements will include body mass index, age- and sex-adjusted anthropometric indicators of muscularity, and calf and thigh circumferences. Physiological measurements will include resting heart rate and oxygen saturation, heart rate recovery after the 1-minute sit-to-stand test, and post-exercise oxygen saturation.
Clinical, laboratory, echocardiographic, and functional data obtained as part of routine clinical follow-up will also be collected. Whenever possible, routine clinical measurements will correspond to assessments performed on the same day as the functional evaluation; measurements obtained within a maximum window of ±15 days will also be considered.
The primary analysis will evaluate the association between the candidate low-cost measurements and the presence of clinical-physiological impairment affecting two or more organ or functional domains. Additional analyses will investigate their ability to identify patients with impairment in at least one domain and to discriminate increasing levels of multisystem clinical-physiological burden.
The study will not involve any therapeutic intervention or prospective study-specific follow-up. The results will be interpreted as cross-sectional associations and will not establish causal or longitudinal prognostic relationships.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | – |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population undergoing the Fontan procedure residing in Spain
Key inclusion criteria (1 listed)
- Patients who meet the following criteria will be eligible to participate in the study: having undergone Fontan surgery at least 2 years prior to enrollment; being between 14 and 60 years of age; be under stable outpatient follow-up by the corresponding clinical unit; and voluntarily agree to participate by signing an informed consent form after having been informed verbally and in writing about the objectives, procedures, risks, and potential benefits of this study. For participants who are minors, consent from their legal guardians and the minor's assent will be requested when appropriate.
Key exclusion criteria (1 listed)
- Patients with an unstable outpatient clinical condition will be excluded, including those scheduled for reoperation or an invasive procedure within 3 months of the evaluation; patients in NYHA functional class IV (symptoms of heart failure even at rest and an inability to perform any physical activity without discomfort. Even minimal exertion may increase dyspnea, fatigue, or palpitations); the presence of physical, neuromuscular, orthopedic, or functional limitations that prevent the safe performance of the motor tasks required for the squat jump or for standing up from a chair; pregnancy; or refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multisystem clinical-physiological impairment affecting ≥2 domains
Time frame: At the study assessment / cross-sectional assessment (single study visit)
Presence of clinical-physiological impairment affecting two or more predefined domains, based on clinical, laboratory, echocardiographic and functional variables obtained during routine follow-up. The domains include cardiopulmonary, cardiac, hepatic, renal, nutritional-lymphatic, and hematological-metabolic domains.
4 secondary outcomes
Clinical-physiological impairment affecting ≥1 domain
Time frame: At the study assessment / cross-sectional assessment
Multisystem clinical-physiological burden
Time frame: At the study assessment / cross-sectional assessment
Discriminative capacity of low-cost functional, anthropometric and physiological variables
Time frame: At the study assessment / cross-sectional assessment
Association between candidate low-cost variables and clinical-physiological impairment
Time frame: At the study assessment / cross-sectional assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Fontan Procedure and Fontan Circulation, run by Universidad de Murcia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Serrano, Research Physical Therapist (+34 606448612, mrserranoaguilar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multisystem clinical-physiological impairment affecting ≥2 domains (time frame: At the study assessment / cross-sectional assessment (single study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.