Clinical trials: Univentricular Heart
Hypovolemia
Prediction of Fluid Responsiveness in Children With Single Ventricle
The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).
- Trial name
- NCT02826135
- Testing
- abdominal compression
- Where
- South Korea
- Volunteers
- 64 people
- Sponsor
- Seoul National University Hospital
Heart Defects, Congenital
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS) compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of the MBTS to that of the RV-to-PA shunt on…
- Trial name
- NCT00115934
- Testing
- Blalock-Taussig pulmonary artery shunt, Right ventricular to pulmonary artery shunt
- Where
- 13 sites in United States, Canada
- Volunteers
- 555 people
- Sponsor
- Carelon Research
Anemia
Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease
Anemia is a common disorder in infants with one working chamber of the heart that pumps blood. Anemia is when the level of healthy blood cells becomes too low.
- Trial name
- NCT00459225
- Testing
- Iron (ferrous sulfate)
- Where
- United States
- Sponsor
- Emory University
Single-ventricle
Inspiratory Muscle Therapy in Subjects With Fontan Circulations
Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory mechanics to support pulmonary blood flow (PBF).
- Trial name
- NCT03339466
- Testing
- Inspiratory muscle therapy
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Single-ventricle
Validation of Cardiac Magnetic Resonance Sequences in Patients With Single Ventricles
Single ventricle defects make up the severe end of the congenital heart disease spectrum. The Fontan operation leads to a complete redirection of systemic venous blood outside of the heart and directly into the lungs.
- Trial name
- NCT04017494
- Testing
- Cardiac Magnetic Resonance Imaging, Blood draw for hematocrit and heart failure biomarkers, Cardiopulmonary exercise test
- Where
- Switzerland
- Volunteers
- 63 people
- Sponsor
- Barbara Burkhardt
Congenital Heart Disease
Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.
- Trial name
- DGX01 (NCT03877965)
- Testing
- Digoxin
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- Christoph P Hornik, MD MPH
Heart Disease
Sildenafil in Single Ventricle Patients
Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance.
- Trial name
- NCT01169519
- Testing
- Sildenafil by injection
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Duke University
Single-ventricle, Pulmonary Hypertension
Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease
In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance.
- Conditions
- Single-ventricle, Pulmonary Hypertension, Univentricular Heart
- Trial name
- VU-INHIB (NCT03997097)
- Testing
- Sildenafil
- Sponsor
- University Hospital, Montpellier
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
Congenital Heart Disease
SVR III: Brain Connectome and Neurodevelopmental Outcomes
Patients with hypoplastic left heart syndrome and other single right ventricle lesions who have undergone the Fontan procedure have a high risk of neurodevelopmental disorders that affect quality of life and adulthood employment.
- Trial name
- SVRIII (NCT02692443)
- Testing
- Magnetic Resonance Imaging, Neurodevelopmental Testing
- Volunteers
- 223 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Single Ventricle Defect
Cerebral Blood Flow in Single Ventricles Throughout Staged Surgical Reconstruction
This study seeks to determine cerebral blood flow changes in single ventricle patients during staged surgical reconstruction as compared with normal children.
- Trial name
- CBF (NCT02135081)
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Children's Hospital of Philadelphia
Congenital Heart Defect, Hypoplastic Left Heart Syndrome
Physical Activity Promotion in Children and Adolescents With Single Ventricle Physiology (MedBike)
Single ventricular (SV) heart was a uniformly fatal condition before the advances in surgical treatment in 1980. In the present era, 5-year survival rate with SV is 75%, with some centers, including the Stollery Children's…
- Conditions
- Congenital Heart Defect, Hypoplastic Left Heart Syndrome, Physical Activity
- Trial name
- MedBike (NCT04056416)
- Testing
- MedBIKE
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- University of Alberta
Single Ventricle Heart Disease After Fontan Surgery
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
The study will investigate the cardiovascular effects of sildenafil on patients with Fontan circulation. Recent studies suggest that sildenafil may improve exercise in patients with Fontan circulation.
- Trial name
- NCT01815502
- Testing
- Cardiac catheterization
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical University of South Carolina
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
Congenital Heart Disease
Pulmonary Capillary Recruitment in Fontan Patients
This study evaluates the effects of pulmonary vasodilator therapy on pulmonary capillary blood flow by measuring the functional capillary surface area (FCSA) at baseline and post nitric oxide inhalation, through the injection of…
- Trial name
- NCT04292483
- Testing
- Nitric Oxide
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- Jewish General Hospital
Congenital Heart Defects, Functional Single Ventricle
Bosentan Therapy in Children With Functional Single Ventricle
Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to investigate if Bosentan therapy can modify the outcome of children with functional single ventricle.
- Trial name
- NCT01662037
- Testing
- Bosentan
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Congenital Heart Disease, Single Ventricle
Changes in Cerebral Oxygenation During Laparoscopy in Patients With Single Ventricle Anatomy
Patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid atresia) frequently have feeding difficulties necessitating procedures such as Nissen fundoplication and G-tube placement.
- Trial name
- NCT02614664
- Testing
- NIRS
- Where
- United States
- Sponsor
- Roby Sebastian
Single Ventricle Physiology
Training in Exercise Activities and Motion for Growth
To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
- Trial name
- T4G (NCT01917084)
- Testing
- Passive range of motion (ROM) exercise
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Carelon Research
Single-ventricle
Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will…
- Trial name
- NCT05634226
- Testing
- Hands-free oral-positive pressure device (oPEP)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Tarek Alsaied
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