An observational study in Single-ventricle, Pulmonary Vascular Resistance Abnormality and Superior Cavo-Pulmonary Anastomosis, sponsored by University of Colorado, Denver. Active, not recruiting at 1 site in United States. Open to participants aged 1 Month to 2 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Colorado, Denver · Observational
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 11th largest by planned enrollment of the 23 observational ones that give a count, is one of 5 that started in 2018, is one of 23 observational ones, reaches primary completion later than 9 of the 15 other live ones, and was the 29th 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: 1 Month to 2 Years · all sexes.
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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 42 across 37 observational 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:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver 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 |
Add all 5 to your calendar (.ics) → With an account.
Among the 55 studies in Univentricular Heart with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a novel preliminary study of biomarkers of pathologic pre-operative pulmonary vascular development, elevated pre-operative Pulmonary Vascular Resistance Index (PVRi), and complications associated with decreased post-operative pulmonary blood flow in single ventricle patients undergoing superior cavo-pulmonary anastomosis (SCPA). The study will utilize a combined targeted and untargeted approach to both optimize translation of a promising existing biomarker and efficiently identify novel biomarkers and potential therapeutic targets in this population.
Overall Hypothesis: Endothelin-1 (ET1) and associated dysregulation of key metabolic pathways decrease pre-operative pulmonary blood vessel development and increase post-operative pulmonary blood vessel resistance leading to decreased pulmonary blood flow in patients undergoing SCPA.
For enrolled patients, collected data will include:
Infants with single ventricle heart disease undergoing trans-catheter evaluation in anticipation of superior cavo-pulmonary anastomosis.
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:
Infants between 1 month and 2 years of age undergoing evaluation for SCPA candidacy.
Other: Research Blood Sampling
Infants between 3 months and 12 months of age with no known cardio-pulmonary disease, no active infection, and no known genetic abnormality undergoing elective surgery for a non-cardiac indication.
Other: Research Blood Sampling
Blood samples will be collected at specified time points and research assays will be performed.
Difference in ET1 concentration between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.
Time frame: 48 hours post-operatively
Difference in metabolomics profile between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.
Time frame: 48 hours post-operatively
Association between ET1 concentration at pre-SCPA catheterization in study patients and clinical metrics of pre-operative pulmonary adequacy.
Time frame: 48 hours post-operatively
Association between metabolomics profile in study patients and clinical metrics of pre-operative pulmonary adequacy.
Time frame: 48 hours post-operatively
Plan to share: No
Started Feb 2018 (actual). Primary completion is estimated for Dec 2027, 118 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →