Condition (MeSH)
Hypoplastic Left Heart Syndrome
ClinicalTrials.gov lists 66 trials for Hypoplastic Left Heart Syndrome or a narrower condition beneath it. Longeveron Inc. has the most among industry and government lead sponsors, with 2.
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Trials per phase
66 of the 66 trials are tagged with Hypoplastic Left Heart Syndrome itself; the rest are tagged with a narrower condition beneath it.
When did Hypoplastic Left Heart Syndrome trials start? (23)
Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 1 trial is registered to start in 2027 or later, and not listed here.
Trials over time, by phase
- Phase 1
- Phase 1/2
- Phase 2
- Phase 3
- Not applicable
- Observational
Top of scale: 5
Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.
| Year | Trials started |
|---|---|
| 2025 | 4 |
| 2024 | 1 |
| 2022 | 2 |
| 2021 | 5 |
| 2020 | 3 |
| 2019 | 5 |
| 2018 | 4 |
| 2017 | 1 |
| 2016 | 4 |
| 2015 | 3 |
Showing 10 of 23 earlier years.
No forecast is made for this condition: it averages 1.4 trial starts a year over the five years to September, under the 5 a year the method needs.
Recruitment duration, a model prediction: 2 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
What phase are Hypoplastic Left Heart Syndrome trials in? (6)
Shown in this order: phase order.
Show the trials by phase as a table
| Phase | Trials |
|---|---|
| Phase 1 | 12 |
| Phase 1/2 | 4 |
| Phase 2 | 7 |
| Phase 3 | 3 |
| Not applicable | 16 |
| Observational | 24 |
How many Hypoplastic Left Heart Syndrome trials are recruiting? (8)
Shown in this order: the order a trial moves through, from not yet recruiting to unknown.
| Status | Trials |
|---|---|
| Not yet recruiting | 2 |
| Recruiting | 8 |
| Enrolling by invitation | 1 |
| Active, not recruiting | 3 |
| Completed | 39 |
Showing 5 of 8 statuses.
Status as registered on ClinicalTrials.gov. Each trial is counted once.
Which lead sponsors run the most Hypoplastic Left Heart Syndrome trials? (1)
Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.
| Sponsor | Trials |
|---|---|
| Longeveron Inc. | 2 |
Which drugs are being tested for Hypoplastic Left Heart Syndrome? (2)
Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.
| Drug | Trials |
|---|---|
| DEXMEDETOMIDINE | 2 |
| SILDENAFIL | 1 |
Interventions as named in the registry (13)
Shown in this order: most trials first.
| Drug | Trials |
|---|---|
| Maternal Hyperoxygenation | 2 |
| Peritoneal dialysis (PD) | 1 |
| Autologous (self) mononuclear cells derived from umbilical cord blood | 1 |
| autologous cell-based delivery | 1 |
| Ventrix Bio Extracellular Matrix | 1 |
Showing 5 of 13 interventions.
These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.
Which serious adverse events do Hypoplastic Left Heart Syndrome trials report? (10)
Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.
| Adverse event | Subjects affected | Trials |
|---|---|---|
| Cardiac disorders - Other specify | 26 | 1 |
| Hypoxia | 20 | 2 |
| Respiratory, thoracic and mediastinal disorders - Other specify | 17 | 1 |
| Respiratory failure | 10 | 2 |
| Gastrointestinal disorders - Other specify | 8 | 1 |
Showing 5 of 10 adverse events.
Which publications cover Hypoplastic Left Heart Syndrome? (105)
Shown in this order: major-topic papers first, then newest, then most linked to trials.
| Publication | Journal | Year | Major topic |
|---|---|---|---|
| Phase I Randomized Study of Cardiac Stem Cells in Patients With Hypoplastic Left Heart Syndrome: The CHILD Trial. | JACC. Heart failure | 2026 | Yes |
| Autologous umbilical cord blood mononuclear cell therapy for hypoplastic left heart syndrome: a nonrandomized control trial of the efficacy and safety of intramyocardial injections. | Stem cell research & therapy | 2025 | Yes |
| Neurodevelopmental Outcomes in Early Adolescence: The Pediatric Heart Network's Single Ventricle Reconstruction Trial. | Circulation | 2025 | Yes |
| Long-Term Survival After Single-Ventricle Palliation: A Swedish Nationwide Cohort Study. | Journal of the American Heart Association | 2024 | Yes |
| School age and adolescent heart failure following the Norwood procedure. | The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation | 2024 | Yes |
Showing 5 of 105 publications.
Prevalence (72)
Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.
| Orphanet disease | Type | Class | Geography | Jurisdiction | Mapping relation |
|---|---|---|---|---|---|
| Hypoplastic left heart syndrome | Prevalence at birth | 1-5 / 10 000 | United Kingdom | GB | Exact |
| Hypoplastic left heart syndrome | Prevalence at birth | 1-5 / 10 000 | United Kingdom | GB | Exact |
| Hypoplastic left heart syndrome | Prevalence at birth | 1-5 / 10 000 | United Kingdom | GB | Unspecified |
| Hypoplastic left heart syndrome | Prevalence at birth | 1-5 / 10 000 | United States | US | Unspecified |
| Hypoplastic left heart syndrome | Prevalence at birth | 1-5 / 10 000 | United States | US | Exact |
Showing 5 of 72 prevalence observations.
Rare-disease identity (2)
Shown in this order: exact, broader, narrower, other.
| Orphanet disease | ORPHA code | Relation | Source |
|---|---|---|---|
| Hypoplastic left heart syndrome | 2248 | Exact | Orphanet Rare Disease Ontology (ORDO) |
| Hypoplastic left heart syndrome | 2248 | Exact | Orphadata Science knowledge files, Product 1 |
Not on this page
Not measured: delivery record.
Checked, with nothing recorded for this condition: sub-conditions in mesh.