Clinical trials: Univentricular Heart
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
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
Pulmonary Hypertension, Heart Failure
Frailty in Children With Cardiac Disease
Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to decreased resistance to stressors and is associated with adverse health outcomes.
- Conditions
- Pulmonary Hypertension, Heart Failure, Single Ventricle
- Trial name
- NCT02999438
- Testing
- Actigraph to check activity levels at home
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
Congenital Heart Disease, Single-ventricle
Clinical Characteristics and Associations of the "Good Fontan" Patient
This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse…
- Trial name
- NCT03470428
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- Boston Children's Hospital
Single-ventricle
Re-Energize Fontan
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high.
- Trial name
- NCT04195451
- Testing
- Live-Video-Supervised Exercise Intervention, Usual Care then Live-Video Supervised Exercise Intervention
- Where
- United States
- Volunteers
- 150 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
Hypoplastic Left Heart Syndrome, Single Right Ventricle
Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)
The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease.
- Conditions
- Hypoplastic Left Heart Syndrome, Single Right Ventricle, Single Left Ventricle
- Trial name
- NCT01829750
- Testing
- Cardiac progenitor cell infusion
- Where
- Japan
- Volunteers
- 34 people
- Sponsor
- Okayama University
Congenital Heart Defect
Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following…
- Trial name
- NCT02860702
- Testing
- Human Milk Derived Fortifier, Human/Bovine Milk
- Where
- 12 sites in United States
- Volunteers
- 16 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
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
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
Single Ventricle Cardiac Anomaly
A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery
An initial feasibility and safety study evaluating the use of autologous tissue engineered vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in children with single ventricle anomalies.
- Trial name
- NCT01034007
- Testing
- Tissue Engineered Vascular Grafts
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Christopher Breuer
Single-ventricle
Fibrosis and the Fontan
The purpose of this study is to non-invasively characterize the fibrotic consequences of single ventricle physiology, its possible solution and effect on lymphatics.
- Trial name
- NCT04901975
- Testing
- Spironolactone
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Children's Hospital of Philadelphia
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
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, 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 Disease
Transfusion Strategies in Pediatric Cardiothoracic Surgery
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects.
- Trial name
- NCT00350220
- Testing
- transfusion strategy, Low Hb transfusion group
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Rochester
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.
Single Ventricle Heart Disease
Cognitive Intervention to Improve Working Memory
Adolescents with single ventricle heart disease (SVHD) (10 males and 10 females) with mild to moderate cognitive impairment will participate in a total of 25 computer-based working memory training sessions, each 30-40 minutes (5…
- Trial name
- NCT03687008
- Testing
- Cognitive Computer Based Intervention
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of California, Los Angeles
Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.
The purpose of this study is to determine whether Bosentan is an effective and safe treatment to adolescent and adult (15 years and older) patients, born with one ventricle of the heart instead of two (single ventricle…
- Conditions
- Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Other Specified Congenital Anomalies of Heart
- Trial name
- TEMPO (NCT01292551)
- Testing
- Bosentan
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 75 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Single-ventricle
Association of Near Infrared Spectroscopy With Interstage Outcomes
The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period.
- Trial name
- NCT06538571
- Testing
- Near infrared spectroscopy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Advocate Hospital System