Univentricular HeartNCT05617534
Impact of Exercise Training on Single Ventricle Function in Paediatric Fontan Patients
An observational study of Univentricular Heart, run by Children's Health Ireland at 1 site in Ireland.
Trial summary
The goal of this observational study is to learn about how a prescribed Exercise Training Program would affect children living with a Fontan circulation. From birth, the children who are born with single functioning ventricle will undergo 3-staged Fontan surgery to achieve a unique Fontan circulation, supported by one… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Univentricular Heart
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 10 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- Child, Adult
Study population: Children aged 8 to 18 years old, who are living with a Fontan circulation, who have met the eligibility criteria listed above.
Who may be able to join
- Patients with Fontan circulation, age range 8 to 18 years
- Ability to perform a cardiopulmonary exercise stress test (CPET)
- Free from acute or chronic respiratory illness and/or conditions that might affect exercise performance
- Who have had a Fontan operation at least six months prior.
Who cannot join
- Existing neuro-disability i.e. with paresis post cerebrovascular accident
- Neurodevelopmental issue with inability to comply with commands.
- Documented life-threatening arrhythmia without implantable cardioverter defibrillator
- Moderate or severe atrio-ventricular valve regurgitation
- Moderate or severe ventricular dysfunction by echocardiography exams
- Acute inflammatory cardiac disease
Show all 11Show fewer
- documented coronary artery stenosis and/or myocardial ischaemia
- Heart failure requiring hospitalisation in the past year
- Evidence of systemic venous pathway obstruction by echocardiography or catheterisation
- Resting oxygen saturation < 90%
- Systemic ventricular outflow tract stenosis with peak resting systolic gradient > 50mmHg
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Children's Health Ireland
Dublin, D12 N512
Li Yen Ng, MB BCh BAO, +353862341835, ngliyen@gmail.com
Adam James, MD, +353871925275, adamoj@gmail.com
About this study
Official title: A Single-centre, Prospective Case Control Study Evaluating the Impact of a Standardised Aerobic and Strength Exercise Regime on Exercise Capacity, Ventricular Function, and Perceived Quality of Life in Paediatric Fontan Patients
The goal of this observational study is to learn about how a prescribed Exercise Training Program would affect children living with a Fontan circulation.
From birth, the children who are born with single functioning ventricle will undergo 3-staged Fontan surgery to achieve a unique Fontan circulation, supported by one functioning ventricle. With advancement in surgical technique and medical care, there are increasing number of children living with Fontan circulating surviving into adulthood.
Read more
A significant number of these individuals develop complications in their adulthood due to problems related to this unique circulation, including reduced exercise tolerance, heart failure, abnormal heart rhythm or premature death. Many of these children have acquired sedentary lifestyle, and may have lower self-perceived health related quality of life.
Exercise training is a well-established therapy used in adult population with heart failure. It has been shown to be safe in children with congenital heart disease and with Fontan circulation, it improves their aerobic exercise capacity which is associated with better outcomes.
The main question[s] it aims to answer are the impact of a Exercise Training program on:
- Single ventricle function
- Exercise capacity
- Self-perceived quality of life
- Skeletal muscle mass
Participants will be given a 20-weeks exercise program, 3 sessions of 30 minutes workout weekly, to carry out at home. The following tests will be performed prior to starting and upon completion of the exercise program:
- Echocardiogram
- Cardiopulmonary exercise test
- Body composition scan using a bio-impedance analyser
- Quality of life questionnaires
- Conditions
- Univentricular Heart
- Keywords
- Fontan, Exercise Training, Ventricular Function, Quality of Life
- Medical subject headings
- Univentricular Heart
What is being measured
The primary outcome is the main question the study is designed to answer.
Single ventricle Function
By implementing a prescribed exercise training regime over a 20 week period, a change will be noted in ventricular function at the subclinical state using Echocardiography parameters.
Measured: After a 20 week Exercise training program
Secondary outcomes (4)
Exercise Capacity
By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in functional exercise capacity, which will be objectively assessed using cardiopulmonary exercise test.
Measured: After a 20 week Exercise training program
Self-perceived Quality of life - Generic
By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in self-reported quality of life, which will be assessed using validated QOL questionnaire - Using Paediatric Quality of Life Inventory, PedsQL v4.0
Measured: After a 20 week Exercise training program
Self-perceived Quality of life - Cardiac module
By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in self-reported quality of life, which will be assessed using validated QOL questionnaire - Using PedsQL Cardiac Module v3.0
Measured: After a 20 week Exercise training program
Skeletal muscle mass
By implementing a prescribed exercise training regime over a 20 week period, an improvement will be noted in the skeletal muscle mass, which will be assessed using a non-invasive bio-impedance analyser.
Measured: After a 20 week Exercise training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start10 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Univentricular HeartStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Health Ireland
- Sponsor type
- Other government
- Collaborators
- CHI Research & Innovation Office
- Responsible party
- Principal investigator, Adam James, Children's Health Ireland
- Investigators
- Adam James, MD, Principal investigator, Children's Health Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617534
- Sponsor's protocol ID
- RSFG-21-ACC13
- Status last verified
- Dec 2022
- First submitted
- 24 Oct 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Prospective Case Control Study Evaluating the Impact of a Standardised Aerobic and Strength Exercise Regime on Exercise Capacity, Ventricular Function, and Perceived Quality of Life in Paediatric Fontan Patients
- ClinicalTrials.gov ID
- NCT05617534
- Acronym / sponsor ID
- RSFG-21-ACC13
- Conditions
- Univentricular Heart
- Keywords
- Fontan, Exercise Training, Ventricular Function, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Health IrelandOther government
- Collaborators
- CHI Research & Innovation Office
- Study start
- 10 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Nov 2022 (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.
The goal of this observational study is to learn about how a prescribed Exercise Training Program would affect children living with a Fontan circulation.
From birth, the children who are born with single functioning ventricle will undergo 3-staged Fontan surgery to achieve a unique Fontan circulation, supported by one functioning ventricle. With advancement in surgical technique and medical care, there are increasing number of children living with Fontan circulating surviving into adulthood.
A significant number of these individuals develop complications in their adulthood due to problems related to this unique circulation, including reduced exercise tolerance, heart failure, abnormal heart rhythm or premature death. Many of these children have acquired sedentary lifestyle, and may have lower self-perceived health related quality of life.
Exercise training is a well-established therapy used in adult population with heart failure. It has been shown to be safe in children with congenital heart disease and with Fontan circulation, it improves their aerobic exercise capacity which is associated with better outcomes.
The main question[s] it aims to answer are the impact of a Exercise Training program on:
- Single ventricle function
- Exercise capacity
- Self-perceived quality of life
- Skeletal muscle mass
Participants will be given a 20-weeks exercise program, 3 sessions of 30 minutes workout weekly, to carry out at home. The following tests will be performed prior to starting and upon completion of the exercise program:
- Echocardiogram
- Cardiopulmonary exercise test
- Body composition scan using a bio-impedance analyser
- Quality of life questionnaires
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children aged 8 to 18 years old, who are living with a Fontan circulation, who have met the eligibility criteria listed above.
Key inclusion criteria (4 listed)
- Patients with Fontan circulation, age range 8 to 18 years
- Ability to perform a cardiopulmonary exercise stress test (CPET)
- Free from acute or chronic respiratory illness and/or conditions that might affect exercise performance
- Who have had a Fontan operation at least six months prior.
Key exclusion criteria (11 listed)
- Existing neuro-disability i.e. with paresis post cerebrovascular accident
- Neurodevelopmental issue with inability to comply with commands.
- Documented life-threatening arrhythmia without implantable cardioverter defibrillator
- Moderate or severe atrio-ventricular valve regurgitation
- Moderate or severe ventricular dysfunction by echocardiography exams
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
Single ventricle Function
Time frame: After a 20 week Exercise training program
By implementing a prescribed exercise training regime over a 20 week period, a change will be noted in ventricular function at the subclinical state using Echocardiography parameters.
4 secondary outcomes
Exercise Capacity
Time frame: After a 20 week Exercise training program
Self-perceived Quality of life - Generic
Time frame: After a 20 week Exercise training program
Self-perceived Quality of life - Cardiac module
Time frame: After a 20 week Exercise training program
Skeletal muscle mass
Time frame: After a 20 week Exercise training program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: No
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Enrolling by invitationObservational study
International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease
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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. This study is not recruiting at the moment.
Adam James, MD principal investigator
Children's Health Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Univentricular Heart, run by Children's Health Ireland at 1 site in Ireland.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yen Ng, MB BCh BAO (+353862341835, ngliyen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single ventricle Function (time frame: After a 20 week Exercise training program). 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 21 Dec 2022.