Single-ventricleNCT04195451
Re-Energize Fontan
A study testing Live-Video-Supervised Exercise Intervention in people with Single-ventricle, run by Stanford University at 1 site in United States.
Trial summary
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. Read more about this study
- Who is it for?
- Ages 8 to 19 years
- Conditions the study is for
- Single-ventricle
- What is being tested?
- Live-Video-Supervised Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 1 Mar 2026
- Phase
- Interventional
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 8-19 years of age
- Fontan palliation
- Ability to fast overnight
- Cardiac clearance to exercise by primary cardiologist
- Presence of an adult at home during exercise sessions for patients <14 years old
- English-speaking patient.
Who cannot join
- NYHA Class IV (severe heart failure)
- Acute illness within the past three months
- Active protein losing enteropathy (albumin <2.5 mg/dL)
- Implanted pacemaker
- Cognitive delay deemed severe enough to inhibit the ability to follow the exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, Lucile Packard Children Hospital
Palo Alto, California, 94304
About this study
Official title: RE-ENERGIZE FONTAN: A RandomizEd Exercise INtERvention DesiGned to MaximIZE Fitness in Pediatric FONTAN Patients
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With >1,000 Fontan palliations performed in the US annually, there is a burgeoning population of Fontan patients at risk for progressive heart failure and death. Factors that contribute to onset and progression of heart failure in Fontan patients remain incompletely understood. However, it is established that Fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. In adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. Limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few Fontan patients. Furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. The investigators propose a milestone-driven, randomized controlled trial in pediatric Fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. The investigators' ultimate goal is the translation of this model to clinical application as an "exercise prescription" to intervene early in pediatric Fontan patients and decrease long-term morbidity and mortality.
- Conditions
- Single-ventricle
- Being tested
- Live-Video-Supervised Exercise Intervention, Usual Care then Live-Video Supervised Exercise Intervention
- Keywords
- Fontan palliation
- Medical subject headings
- Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live-Video-Supervised Exercise InterventionOther
The live-video-supervised exercise intervention includes exercise sessions x3/week for 3 months, and then maintenance regimen for 6 months. Maintenance includes live-video-supervised exercise sessions, only x1/week, and self-exercise x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker.
Usual Care then Live-Video Supervised Exercise InterventionOther
Patients randomized to usual care at baseline will receive usual care for 9 months and will then start the live-video-supervised exercise intervention that includes exercise sessions x3/week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Live Video-Supervised Exercise Intervention Arm | Experimental | Patients randomized to exercise intervention at baseline will participate in live-video-supervised exercise sessions x3/week for 3 months, and then will follow a maintenance regimen for 6 months. During maintenance, patients will continue live-video-supervised exercise sessions, only x1/week, and will be instructed to exercise on their own x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker. Receives: Other: Live-Video-Supervised Exercise Intervention |
| Live-Video-Supervised Exercise Control Arm | Experimental | Patients randomized to usual care at baseline will receive usual care for 9 months and will then start the 3-month exercise intervention of live-video-supervised exercise sessions x3/week for 3 months. Receives: Other: Usual Care then Live-Video Supervised Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in volume of Oxygen Consumed at Maximal Exertion
In Fontan patients, peak VO2 is a powerful predictor of poor outcomes. The subjects will undergo progressive cardiopulmonary exercise testing with continuous monitoring by 12-lead EKG and gas exchange by measuring breath-to-breath ventilation. Exercise capacity will be measured by a cardiopulmonary exercise test to obtain the peak VO2
Measured: Baseline, 3 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start6 Aug 2020
- Primary completion27 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Single-ventricleStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Seda Tierney, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195451
- Sponsor's protocol ID
- 46606
- Other IDs
- R33HL146775, 1R61HL146775-01A1
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2019
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lui MC, Palaniappan L, Leonard MB, Long J, Dehoney J, Cooke JP, Olson I, Damase TR, Chen S, Myers J, Bernstein D, Tierney S. Exercise Capacity, Endothelial Function, Muscle Mass, and Strength in Pediatric Patients With Fontan Circulation. CJC Pediatr Congenit Heart Dis. 2025 Nov 5;5(3):119-128. doi: 10.1016/j.cjcpc.2025.10.010. eCollection 2026 Jun.
PubMed 42422410Gallegos FN, Bernstein D, Punn R, Long J, Stauffer KJ, Thorson K, Chen S, Lui MC, Olson I, Myers J, Palaniappan L, Tierney S. Systolic performance of the single ventricle, exercise capacity, and endothelial function in pediatric Fontan patients. Am Heart J. 2025 Dec;290:58-68. doi: 10.1016/j.ahj.2025.05.015. Epub 2025 May 31.
PubMed 40456431Selamet Tierney ES, Palaniappan L, Leonard M, Long J, Myers J, Davila T, Lui MC, Kogan F, Olson I, Punn R, Desai M, Schneider LM, Wang CH, Cooke JP, Bernstein D. Design and rationale of re-energize fontan: Randomized exercise intervention designed to maximize fitness in fontan patients. Am Heart J. 2023 May;259:68-78. doi: 10.1016/j.ahj.2023.02.006. Epub 2023 Feb 14.
PubMed 36796574
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RE-ENERGIZE FONTAN: A RandomizEd Exercise INtERvention DesiGned to MaximIZE Fitness in Pediatric FONTAN Patients
- ClinicalTrials.gov ID
- NCT04195451
- Acronym / sponsor ID
- 46606
- Conditions
- Single-ventricle
- Keywords
- Fontan palliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 11 Dec 2019 (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.
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With >1,000 Fontan palliations performed in the US annually, there is a burgeoning population of Fontan patients at risk for progressive heart failure and death. Factors that contribute to onset and progression of heart failure in Fontan patients remain incompletely understood. However, it is established that Fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. In adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. Limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few Fontan patients. Furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. The investigators propose a milestone-driven, randomized controlled trial in pediatric Fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. The investigators' ultimate goal is the translation of this model to clinical application as an "exercise prescription" to intervene early in pediatric Fontan patients and decrease long-term morbidity and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live Video-Supervised Exercise Intervention Arm | Experimental | Other: Live-Video-Supervised Exercise InterventionPatients randomized to exercise intervention at baseline will participate in live-video-supervised exercise sessions x3/week for 3 months, and then will follow a maintenance regimen for 6 months. During maintenance, patients will continue live-video-supervised exercise sessions, only x1/week, and will be instructed to exercise on their own x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker. |
| Live-Video-Supervised Exercise Control Arm | Experimental | Other: Usual Care then Live-Video Supervised Exercise InterventionPatients randomized to usual care at baseline will receive usual care for 9 months and will then start the 3-month exercise intervention of live-video-supervised exercise sessions x3/week for 3 months. |
Who may qualify
- Ages
- 8 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 8-19 years of age
- Fontan palliation
- Ability to fast overnight
- Cardiac clearance to exercise by primary cardiologist
- Presence of an adult at home during exercise sessions for patients <14 years old
Key exclusion criteria (5 listed)
- NYHA Class IV (severe heart failure)
- Acute illness within the past three months
- Active protein losing enteropathy (albumin <2.5 mg/dL)
- Implanted pacemaker
- Cognitive delay deemed severe enough to inhibit the ability to follow the exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live-Video-Supervised Exercise InterventionThe live-video-supervised exercise intervention includes exercise sessions x3/week for 3 months, and then maintenance regimen for 6 months. Maintenance includes live-video-supervised exercise sessions, only x1/week, and self-exercise x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker. | Other | Live Video-Supervised Exercise Intervention Arm |
| Usual Care then Live-Video Supervised Exercise InterventionPatients randomized to usual care at baseline will receive usual care for 9 months and will then start the live-video-supervised exercise intervention that includes exercise sessions x3/week for 3 months. | Other | Live-Video-Supervised Exercise Control Arm |
Primary outcome
Change in volume of Oxygen Consumed at Maximal Exertion
Time frame: Baseline, 3 months, 9 months, 12 months
In Fontan patients, peak VO2 is a powerful predictor of poor outcomes. The subjects will undergo progressive cardiopulmonary exercise testing with continuous monitoring by 12-lead EKG and gas exchange by measuring breath-to-breath ventilation. Exercise capacity will be measured by a cardiopulmonary exercise test to obtain the peak VO2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Derived from this study: PubMed 42422410Lui MC, Palaniappan L, Leonard MB, Long J, Dehoney J, Cooke JP, Olson I, Damase TR, Chen S, Myers J, Bernstein D, Tierney S. Exercise Capacity, Endothelial Function, Muscle Mass, and Strength in Pediatric Patients With Fontan Circulation. CJC Pediatr Congenit Heart Dis. 2025 Nov 5;5(3):119-128. doi: 10.1016/j.cjcpc.2025.10.010. eCollection 2026 Jun.
- Derived from this study: PubMed 40456431Gallegos FN, Bernstein D, Punn R, Long J, Stauffer KJ, Thorson K, Chen S, Lui MC, Olson I, Myers J, Palaniappan L, Tierney S. Systolic performance of the single ventricle, exercise capacity, and endothelial function in pediatric Fontan patients. Am Heart J. 2025 Dec;290:58-68. doi: 10.1016/j.ahj.2025.05.015. Epub 2025 May 31.
- Derived from this study: PubMed 36796574Selamet Tierney ES, Palaniappan L, Leonard M, Long J, Myers J, Davila T, Lui MC, Kogan F, Olson I, Punn R, Desai M, Schneider LM, Wang CH, Cooke JP, Bernstein D. Design and rationale of re-energize fontan: Randomized exercise intervention designed to maximize fitness in fontan patients. Am Heart J. 2023 May;259:68-78. doi: 10.1016/j.ahj.2023.02.006. Epub 2023 Feb 14.
- Individual participant dataSharing planned: No
Related trials for Single-ventricle
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
RecruitingPhase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Central Nervous System Neoplasms, Glioblastoma
RecruitingObservational study
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live-Video-Supervised Exercise Intervention in people with Single-ventricle, run by Stanford University at 1 site in United States.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jun 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in volume of Oxygen Consumed at Maximal Exertion (time frame: Baseline, 3 months, 9 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04195451, which also lists 3 linked publications.
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 22 Jun 2026.