An interventional study of Exercise in Single-ventricle and Myocardial Fibrosis, sponsored by Maria Bano. Active, not recruiting at 1 site in United States. Open to participants aged 10 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by Maria Bano · Not applicable, Interventional, and Treatment
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Among 55 studies in Univentricular Heart with a site in United States — 13 open to participants now, 16 under way, none of them phase 3. Univentricular Heart · United States.
Among the 55 studies in Univentricular Heart with a site in United States, this one is the 9th largest by planned enrollment of the 32 interventional ones that give a count, is one of 5 that started in 2018, is one of 17 with no phase, reaches primary completion later than 1 of the 15 other live ones, and was the 27th registered.
86 studies on the registry are indexed under Univentricular Heart; 22 are open to participants now.
Browse Univentricular Heart studies →13 of the 55 studies in Univentricular Heart with a site in United States are open now. Recruiting first, the newest first:
Le Bonheur Children's Hospital · Sites in United States
Ages 0 mo–12 mo
University of Texas Southwestern Medical Center · Sites in United States
Ages 18–45 · Healthy volunteers
Children's Hospital Los Angeles · Sites in United States
Ages 12–21
Driscoll Children's Hospital · Sites in United States
Ages 0 mo–6 mo
Children's Hospital of Philadelphia · Sites in United States
Ages 10–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Univentricular Heart studies recruiting now, 8 (38%) set no upper age limit and 13 (62%) stop at 75 or younger; 16 take children under 18; 1 takes healthy volunteers.
This study: 10 Years to 40 Years · all sexes · healthy volunteers too.
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55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 9 · Phase 3 4 · Phase 4 2
First in 2000; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is above the median of 28 across 44 interventional studies indexed under Univentricular Heart.
Median enrollment 24 across the 32 interventional studies, 30 across the 23 observational. Of the 36 that completed or were terminated, 12 (33%) have results posted.
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2 of 55 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Maria Bano as lead sponsor.
Maria Bano has 1 study filed under Univentricular Heart — fewer than ten, so there is no comparison to draw.
5 of the studies in Univentricular Heart with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06434207Boston Children's HospitalExtracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis | 2026-12-01 |
| NCT06150950Stanford UniversityREHAB Fontan Failure: A Trial of Cardiac Rehabilitation | 2026-12-31 |
| NCT05262907Duke UniversityVentripoint Single Ventricle Study | 2027-08 |
| NCT05647213HeartWorks, Inc.Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease | 2027-09 |
| NCT07220226University of Texas Southwestern Medical CenterVenous Compression in Fontan | 2027-11-01 |
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Among the 55 studies in Univentricular Heart with a site in United States, from their registry updates:
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This is a single center prospective longitudinal exercise training study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years.
Participants will undergo an MRI of the Fontan circulation. This will include imaging of the heart, lung and liver. This will include specific imaging for tissue characterization and assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow. The investigators will then draw blood (approximately 10 ml) for assessment of serum biomarkers and circulating microRNAs of interest. The participants will undergo exercise testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6 month study period the participants will return back for a follow up and repeat all the testing completed at enrollement.
This is a single center prospective longitudinal study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years. The investigators will enroll from pediatric cardiology and heart failure clinics and inpatient care units at Children's Health Dallas, adult congenital heart disease clinics and inpatient care units at Clements University Hospital and the Clinical Heart Center. This study will evaluate the multimodality biomarkers for assessment of Fontan circulation including heart, liver and lung and change in these markers with exercise training.
Participants will receive an MRI of the Fontan circulation. This will include imaging of the heart, lung and liver. A blood draw (approximately 10 ml) for assessment of serum biomarkers and circulating microRNAs of interest will be completed. The participants will also complete exercise testing and will then start a 3-6 month long cardiac rehabilitation program. Frequent phone follow up (conducted by the research staff) and regular download of data from heart rate monitors will ensure adherence.
After the 3-6 month study period the participants will return for a follow up and repeat all testing completed at enrollment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All Fontan patients included in this study will be part of an exercise intervention 2-6 times/week for 3-6 months.
Behavioral: Exercise
Exercise training all patients enrolled.
Also known as: Training
Peak VO2
Improvement in Peak VO2 with 6 months of exercise training
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Jun 2025, 89 months after the start.
Of 20 interventional studies with no phase under Univentricular Heart, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 63. This study's planned 89 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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