Clinical trials: Univentricular Heart
Univentricular Heart
Factors Associated With Normal Exercise Capacity in Patients With Single Ventricle
The congenital heart disease (CHD) is the firts cause of congenital birth defects. Medical and surgical advances completely changed the epidemiology of CHD.
- Trial name
- SV (NCT04026542)
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Montpellier
mHealth, Adherence, Patient
Parental Experience in the Single Ventricle Interstage Utilizing a mHealth Innovation: A Comparative Case Study
The purpose of this study is to provide a rich description of the parental perspectives of utilizing a mHealth application for data transfer during the single ventricle interstage monitoring period.
- Trial name
- NCT03231020
- Testing
- Interview
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Children's Mercy Hospital Kansas City
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, 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
Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
The purpose of this study is to test the efficacy of treprostinil (TRE) in the perioperative non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube drainage (in days).
- Trial name
- NCT02498444
- Testing
- Treprostinil
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Stanford University
Heart Disease, Congenital, Single Ventricle
Single Ventricle Outcome
The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.
- Conditions
- Heart Disease, Congenital, Single Ventricle, Hypoplastic Left Heart Syndrome
- Trial name
- NCT00308217
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Emory University
Tetralogy of Fallot, Hypoplastic Left Heart Syndrome
Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease
Positive intra-thoracic pressures induced by mechanical ventilation can negatively impact right heart hemodynamics by restricting systemic venous return and increasing right ventricular afterload.
- Conditions
- Tetralogy of Fallot, Hypoplastic Left Heart Syndrome, Univentricular Heart, Heart Defects, Congenital
- Trial name
- NCT04581668
- Testing
- Two ventilation periods with two different modes: conventional ventilation followed by NAVA.
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- St. Justine's Hospital
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
The objective of this observational study is to investigate the long-term safety of autologous cardiac stem cells (JRM-001) administered to patients with single ventricle physiology.
- Trial name
- NCT07884318
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Single Ventricle, Fontan
Effect of Carvedilol on Exercise Performance in Fontan Patients
This study evaluates the effect of carvedilol in patients who have undergone a Fontan heart operation. All participants will receive carvedilol and placebo for 12 weeks.
- Trial name
- NCT02946892
- Testing
- Carvedilol
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Texas Southwestern Medical Center
Hypoplastic Left Heart Syndrome, Atrioventricular Canal
Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle
Patients under the age of 5, with a diagnosis of hypoplastic left heart syndrome (HLHS), unbalanced atrioventricular canal (uAVC), or borderline left heart who are undergoing staged LV recruitment following bidirectional Glenn…
- Trial name
- NCT03079401
- Testing
- MPC; rexlemestrocel-L
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Boston Children's Hospital
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 Physiology
Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation…
- Trial name
- NCT02995577
- Testing
- Feeding tolerant, Feeding intolerant, Necrotizing enterocolitis
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The University of Texas Health Science Center, Houston
Protein Losing Enteropathy
Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery
Protein Losing Enteropathy (PLE) is a serious medical condition that may develop in children and adults with congenital heart disease for which a palliative procedure known as the "Fontan procedure" has been performed.
- Trial name
- NCT01161641
- Testing
- ODSH at 0.125 mg/kg/h, ODSH at 0.375 mg/kg/h, ODSH at 0.250 mg/kg/h
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Jazz Pharmaceuticals
Congenital Heart Disease
Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome
There have been many improvements in the care of children with hypoplastic left heart syndrome (HLHS). This has helped these children survive longer.
- Trial name
- NCT00399555
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Emory University
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
Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Sildenafil After the Fontan Operation
In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation.
- Trial name
- SAFO (NCT00507819)
- Testing
- Sildenafil
- Volunteers
- 28 people
- Sponsor
- Children's Hospital of Philadelphia
Fontan Physiology Patients With PB or PLE, Fontan Physiology Patients Without PB or PLE
Plastic Bronchitis and Protein Losing Enteropathy in Children With Single Ventricle Physiology
The investigators are studying what causes Plastic Bronchitis and Protein Losing Enteropathy. The investigators think that these problems are from too much of two small proteins called Vasoactive Intestinal Peptide (VIP) and…
- Trial name
- NCT01563757
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
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 Heart Disease
Fontan Udenafil Exercise Longitudinal Assessment Trial
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 subjects who have undergone the Fontan…
- Trial name
- FUEL (NCT02741115)
- Testing
- Udenafil
- Where
- 30 sites in United States, Canada and 1 more
- Volunteers
- 400 people
- Sponsor
- Mezzion Pharma Co. Ltd
Univentricular Heart, Children, Adult
Respiratory Drive in Patients With Univentricular Congenital Heart Disease
The aim is to evaluate the correlation between the respiratory control to hypercapnia at rest and the VE/VCO2 slope measured during cardiopulmonary exercise testing.
- Trial name
- NCT03818373
- Testing
- polysomnography
- Where
- 2 sites in France
- Volunteers
- 32 people
- Sponsor
- University Hospital, Montpellier