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Why fontan hearts struggle to exercise: researchers probe the lungs

NCT ID NCT05684562

Knowledge-focused Sponsor: Hacettepe University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

People born with single-ventricle heart disease often have the Fontan operation, which reroutes blood flow but leaves them with reduced exercise capacity. Researchers at Hacettepe University are measuring lung function and breathing muscle strength alongside treadmill exercise tests in 78 patients aged 8 to 55 who had the Fontan operation. The goal is to understand how much the lungs, rather than the heart alone, limit how well these patients can exercise.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If researchers learn which lung measures limit exercise after the Fontan operation, that could shape breathing and fitness programs for these patients.
What could go wrong
This is a small observational study at one hospital, so its findings may not apply to all Fontan patients. It tests no treatment, so it cannot show that any therapy improves fitness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

8 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital heart disease Fontan procedure

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Hacettepe Unıversity

    RECRUITING

    Ankara, Turkey (Türkiye)

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