Univentricular Heart clinical trials
The registry lists 86 studies for Univentricular Heart across more than 10 countries. 22 are recruiting or about to start. 51 of them are mainly about Univentricular Heart (how this is decided). Per ClinicalTrials.gov, last updated 2026-11-10.
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Who runs them
Boston Children's Hospital (7) · Emory University (4) · Children's Hospital of Philadelphia (4) · University Hospital, Montpellier (4) · University of Aarhus (3) · University of Michigan (3) · Stanford University (3) · Children's Mercy Hospital Kansas City (3)
What is being tested here
Drugs under test in Univentricular Heart studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| Arginine Vasopressin | 0 | 2 | 2 |
| Digoxin | 0 | 0 | 1 |
| Spironolactone | 0 | 0 | 1 |
| Carvedilol | 0 | 0 | 1 |
| Ambrisentan | 0 | 0 | 1 |
| Tadalafil | 0 | 0 | 1 |
| Macitentan | 0 | 1 | 1 |
| Colchicine | 0 | 1 | 1 |
| Treprostinil | 0 | 0 | 1 |
| Sildenafil | 0 | 1 | 1 |
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
All 7
- Dec 2026Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis · Boston Children's Hospital
- Dec 2026REHAB Fontan Failure: A Trial of Cardiac Rehabilitation · Stanford University
- Mar 2027Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD · Sisca Natalia Siagian
- Aug 2027Ventripoint Single Ventricle Study · Duke University
- Sep 2027Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease · HeartWorks, Inc.
- Sep 2027Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart · Berlin Heart GmbH
- Nov 2027Venous Compression in Fontan · University of Texas Southwestern Medical Center
Who these studies take
Of the 21 Univentricular Heart studies recruiting now, 8 (38%) set no upper age limit and 13 (62%) stop at 75 or younger. 16 (76%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 1 (5%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 8 (38%) | 8 (38%) |
| 18 | 13 (62%) | 13 (62%) |
| 30 | 12 (57%) | 12 (57%) |
| 40 | 12 (57%) | 12 (57%) |
| 50 | 10 (48%) | 10 (48%) |
| 65 | 8 (38%) | 8 (38%) |
| 75 | 8 (38%) | 8 (38%) |
| 85 | 8 (38%) | 8 (38%) |
Across all 86 studies, recruiting or not: 58% stop at 75 or younger and 58% at 65; 83% take children; 1% are for women only and 0% for men only; 14% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
How long Univentricular Heart studies take
Of 20 interventional studies with no phase under Univentricular Heart, half reached primary completion within 44 months of starting, counting those still running.
| Start to primary completion | Every sponsor | Industry | Non-industry |
|---|---|---|---|
| Interventional, no phase | 44 mo15–63 · 20 studies | — | — |
Each figure is the month by which half the studies had reached primary completion, with the range in which the middle half did. Studies still running count until their last registry update; studies that stopped early are left out. Phase 1 includes early phase 1; observational means prospective or not stated, as retrospective and cross-sectional studies date a window of data rather than a study. How these figures are worked out
What changed recently
From the registry's own updates since Oct 14, 2026.
Newly registered1
Studies
Recruiting first, then most recently updated. Showing 50 of 86. Browse all 86 → or search them.
- Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular GraftsRecruitingNCT04467671Phase 21 country
- Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart DiseaseRecruitingNCT078843181 country
- Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)RecruitingNCT02781922Phase 31 country
- Venous Compression in FontanRecruitingNCT07220226Not applicable1 country
- PRecision Integrated Saturation MonitorRecruitingNCT076863411 country
- Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle PhysiologyRecruitingNCT07087782Not applicable1 country
- Fontan Outcomes in Oligemia vs Plethora in Univentricular CHDRecruitingNCT075352031 country
- Occlutech AFR Fontan StudyNot yet recruitingNCT075323691 country
- Fontan Fitness TrialRecruitingNCT06918795Not applicable1 country
- Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart DiseaseRecruitingNCT05647213Phase 11 country
- Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal ThrombosisRecruitingNCT064342071 country
- Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i RegistryRecruitingNCT069320815 countries
- REHAB Fontan Failure: A Trial of Cardiac RehabilitationRecruitingNCT06150950Not applicable1 country
- Ventripoint Single Ventricle StudyRecruitingNCT05262907Not applicable1 country
- Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise CapacityRecruitingNCT070736121 country
- NIRS in Congenital Heart Defects - Correlation With EchocardiographyRecruitingNCT041064791 country
- Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right HeartRecruitingNCT047822321 country
- An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart DiseaseRecruitingNCT067680081 country
- Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan CirculationRecruitingNCT067355211 country
- Association of Near Infrared Spectroscopy With Interstage OutcomesRecruitingNCT06538571Not applicable1 country
- Prospective Evaluation of Univentricular HeartsRecruitingNCT05620030Not applicable1 country
- Fontan-SprechstundeRecruitingNCT05563376Not applicable1 country
- Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart DiseaseCompletedNCT04581668Not applicable1 country
- PK/PD of Digoxin in Infants With SVHDCompletedNCT06613477Phase 1/21 country
- Characterizing the Effect of Dopamine on Markers of Lymph Re-circulation in Fontan-associated Protein-losing EnteropathyTerminatedNCT033223451 country
- Fibrosis and the FontanCompletedNCT04901975Phase 1/21 country
- Re-Energize FontanCompletedNCT04195451Not applicable1 country
- Interstage Monitoring Using an Implantable Loop Recorder: A Pilot StudyCompletedNCT05744934Early Phase 11 country
- ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary AnastomosisActive, not recruitingNCT034042581 country
- Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart SyndromeActive, not recruitingNCT03779711Phase 21 country
- Training in Exercise Activities and Motion for GrowthCompletedNCT01917084Not applicable1 country
- Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post FontanCompletedNCT05634226Not applicable1 country
- Virtual Remote Physiological Monitoring Program of Children With Heart DiseaseCompletedNCT05034354Not applicable1 country
- Cerebral Anatomy, Hemodynamics and MetabolismCompletedNCT029199561 country
- Effect of Muscle Strengthening Training in Adults with Fontan CirculationCompletedNCT05454254Not applicable1 country
- Use of Vasopressin Following the Fontan OperationCompletedNCT02975999Phase 2/31 country
- Hemodynamic, Vascular and Muscular Parameters of Exercise Capacity in Single-Ventricle Patients With Fontan ProcedureCompletedNCT050115651 country
- Inspiratory Muscle Therapy in Subjects With Fontan CirculationsCompletedNCT03339466Not applicable
- Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single VentricleCompletedNCT051181521 country
- Exclusive Human Milk Feeding in Infants With Single Ventricle PhysiologyCompletedNCT02860702Not applicable1 country
- Lymphatic Function in Patients With Fontan Circulation: Effect of Physical TrainingCompletedNCT05934578Not applicable1 country
- Frailty in Children With Cardiac DiseaseCompletedNCT029994381 country
- Lymphatic Morphology of Fontan PatientsCompletedNCT041636531 country
- Enhanced External Counterpulsation in Patients With Fontan CirculationCompletedNCT04956952Not applicable1 country
- Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart DiseaseWithdrawnNCT03997097Phase 3
- The Effect of Fontan Fenestration Closure on Hepatic StiffnessCompletedNCT034819851 country
- Clinical Characteristics and Associations of the "Good Fontan" PatientCompletedNCT034704281 country
- An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.TerminatedNCT03775421Phase 311 countries
- Respiratory Drive in Patients With Univentricular Congenital Heart DiseaseCompletedNCT03818373Not applicable1 country
- Impact of Exercise Training on Single Ventricle Function in Paediatric Fontan PatientsStatus unknownNCT056175341 country