Clinical trials: Univentricular Heart, open to volunteers
Univentricular Heart, Congenital Heart Disease
Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease.
- Conditions
- Univentricular Heart, Congenital Heart Disease, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Trial name
- NCT05647213
- Testing
- iPSC-CL
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- HeartWorks, Inc.
Heart Failure Congenital, Single-ventricle
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life. 1.
- Trial name
- NCT06150950
- Testing
- Cardiac rehabilitation, Usual care
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Stanford University
Congenital Heart Disease, Single-ventricle
Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery.
- Conditions
- Congenital Heart Disease, Single-ventricle, Thrombosis
- Trial name
- EVmiRNA (NCT06434207)
- Testing
- Collecting discarded blood samples
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Boston Children's Hospital
Single-ventricle, Congenital Heart Disease
Fontan Fitness Trial
The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention.
- Trial name
- NCT06918795
- Testing
- Digital Exercise Intervention
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Philadelphia
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Fontan Circulation
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.
- Trial name
- IMPROVE-FALD (NCT06324396)
- Testing
- Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg), Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Mercy Hospital Kansas City
Single-ventricle, Fontan Circulation
Venous Compression in Fontan
The aim of this study is to investigate whether venous compression garments increase exercise stroke volume in patients with Fontan circulation. To address this aim, we will test the following hypotheses: 1.
- Trial name
- NCT07220226
- Testing
- Lower extremity compression garments, Without compression garments
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Failure of Fontan Type Circulation, Fenestration
Occlutech AFR Fontan Study
The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation.
- Conditions
- Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly
- Trial name
- NCT07532369
- Testing
- Occlutech Atrial Flow Regulator Retrospective Data Collection
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Occlutech International AB
Single-ventricle, Stenosis
Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
The goal of this observational study is to assess the clinical impact following Fontan stent placement for extracardiac Fontan conduit (EFC) stenosis in patients with single-ventricle Fontan-palliated patients ages 12-21 years…
- Trial name
- NCT07073612
- Testing
- Cardiopulmonary Exercise Testing (CPET), Shear Wave Elastography Scan
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital Los Angeles
Heart Failure, Univentricular Heart
Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks…
- Conditions
- Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases
- Trial name
- RegiVe (NCT04782232)
- Testing
- No intervention
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Berlin Heart GmbH
Congenital Heart Disease
International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease
The international multicenter registry aims to collect real-world data on clinical outcomes and evaluate the net clinical success of transcatheter microvascular plug (MVP)-based pulmonary flow restrictors (PFRs) in patients with…
- Trial name
- RESTRICT (NCT07791069)
- Testing
- Transcatheter pulmonary flow restriction
- Where
- 5 sites in France, Germany and 3 more
- Volunteers
- 150 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Univentricular Heart, Microvascular Dysfunction
Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation
Univentricular heart (UVH) is a severe congenital heart disease. Accurate advanced non-invasive diagnostic methods is limited. Cardiovascular magnetic resonance (CMR) imaging has evolved as a particularly useful tool for the…
- Conditions
- Univentricular Heart, Microvascular Dysfunction, Heart Failure, Magnetic Resonance
- Trial name
- CMR_TCPC (NCT06735521)
- Testing
- Cardiac magnetic resonance stress-perfusion
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Karolinska Institutet
Univentricular Heart
Fontan-Sprechstunde
After successful Fontan surgery, the risk of mortality in childhood is only low. Unfortunately, some of the patients suffer from Fontan-typical long-term complications in the long-term course, whereby protein loss neuropathy must…
- Trial name
- NCT05563376
- Testing
- Univentricular Hearts
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Single Ventricle Heart Disease
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.
- Trial name
- FUEL-2 (NCT05918211)
- Testing
- Udenafil
- Where
- 40 sites in United States, South Korea
- Volunteers
- 436 people
- Sponsor
- Mezzion Pharma Co. Ltd
Single-ventricle
Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
This study is testing whether a special formula called Fortini, which is a high-calorie, low osmolality formula can help high-risk babies with single ventricle physiology grow better after their initial Stage 1 surgical…
- Trial name
- NCT07087782
- Testing
- Fortini formula, Standard Nutritional Care
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Driscoll Children's Hospital
Congenital Heart Disease, Single-ventricle
Ventripoint Single Ventricle Study
This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles.
- Trial name
- NCT05262907
- Testing
- Transthoracic Echocardiogram or Cardiac MRI, Ventripoint Echocardiogram
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Duke University
Congenital Heart Disease, Coarctation of Aorta
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative…
- Conditions
- Congenital Heart Disease, Coarctation of Aorta, Aortic Stenosis, Pulmonary Atresia
- Trial name
- NCT06768008
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Beijing Anzhen Hospital
Fontan Circulation, Single Ventricle Heart Disease
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.
- Conditions
- Fontan Circulation, Single Ventricle Heart Disease, HFpEF - Heart Failure With Preserved Ejection Fraction
- Trial name
- NCT06762964
- Testing
- Dapagliflozin tablet
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Mayo Clinic
Adult Congenital Heart Disease, Congenital Heart Disease
Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry
This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns…
- Conditions
- Adult Congenital Heart Disease, Congenital Heart Disease, Systemic Right Ventricle, Transposition of the Great Arteries
- Trial name
- ACHIEVE-SGLT2i (NCT06932081)
- Testing
- SGLT2 inhibitors
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 400 people
- Sponsor
- Leiden University Medical Center
CHD - Congenital Heart Disease, Single Ventricle Heart Disease
PRecision Integrated Saturation Monitor
The purpose of this study is to find out if an abdominal pulse oximeter device is as accurate as a conventional fingertip pulse oximeter in pediatric patients.
- Trial name
- PRISM (NCT07686341)
- Testing
- vital sign monitoring
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Le Bonheur Children's Hospital