Clinical trials: Single Ventricle
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
Single-ventricle, Posttraumatic Stress Disorder
The PaTHS Descriptive Correlational Longitudinal Study
The primary objective of this study is to measure parent's post-traumatic stress before and after their infant's second palliative heart surgery for single ventricle congenital heart disease.
- Conditions
- Single-ventricle, Posttraumatic Stress Disorder, Psychosocial Impairment
- Trial name
- PaTHS (NCT04785482)
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Children's Mercy Hospital Kansas City
Single-ventricle, Heart Diseases
Colchicine in Postoperative Fontan Patients
The investigators found that there is inflammation in the chest drainage in patients after the Fontan operation. The investigators want to test the theory that Colchicine, an anti- inflammatory medication, can decrease the…
- Trial name
- CPFP (NCT03575572)
- Testing
- Colchicine
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Michigan
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
Single-ventricle, Fontan Procedure
Exercise Capacity in Patients With Fontan Procedure
In literature, it has been reported that exercise capacity decreases in single-ventricle patients undergoing Fontan Procedure due to various factors related to surgery and underlying cardiac anomaly.
- Trial name
- NCT05063903
- Testing
- Demographic and clinical characteristics, incremental shuttle walk test, six minute walk test, hand grip strength, M. Quadriceps isometric muscle strength, body composition
- Where
- Turkey (Türkiye)
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
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
Hypoplastic Left Heart Syndrome, Single Ventricle
Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac output.
- Conditions
- Hypoplastic Left Heart Syndrome, Single Ventricle, Heart Failure
- Trial name
- TICAP (NCT01273857)
- Testing
- Autologous cardiac progenitor cell transplantation, staged shunt procedure
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Okayama University
Single-ventricle, Congenital Heart Disease
Fontan Imaging Biomarkers (FIB) Study
The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.
- Trial name
- FIB (NCT03119090)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Children's Hospital
Single-ventricle, Myocardial Fibrosis
Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient
This is a single center prospective longitudinal exercise training study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years.
- Trial name
- NCT03263312
- Testing
- Exercise
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Maria Bano
Single-ventricle, Congenital Heart Disease
Redesigning the Care Journey of Patients With Single-ventricle Congenital Heart Disease
In this three-party collaboration, which includes The Texas Center for Pediatric and Congenital Heart Disease, the Value Institute for Health and Care, and the Design Institute for Health, all from University of Texas (UT) Dell…
- Trial name
- NCT04613934
- Where
- United States
- Volunteers
- 142 people
- Sponsor
- University of Texas at Austin
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
Circulatory Perfusion Disorder, Congenital Heart Disease
Early Use of Vasopressin in Post-Fontan Management
This is an investigator initiated, prospective, single-center, double-blinded, randomized, placebo-controlled trial of post-operative low dose vasopressin infusions as an early treatment of low systemic perfusion in pediatric…
- Conditions
- Circulatory Perfusion Disorder, Congenital Heart Disease, Single-ventricle
- Trial name
- VAMP (NCT03088345)
- Testing
- Vasopressin, Arginine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
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, Single Ventricle
Diffuse Myocardial Fibrosis in Fontan Patients
The purpose of this protocol is to measure the relaxation of the heart in subjects with single ventricles who have undergone the surgical Fontan procedure.
- Conditions
- Congenital Heart Disease, Single Ventricle, Myocardial Fibrosis
- Trial name
- NCT01929174
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Oregon Health and Science University
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
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 Fontan Palliation
The Effects of Ambrisentan on Exercise Capacity in Fontan Patients
Hypothesis: Patients with a Fontan type palliation are limited by preload, or the rate at which blood returns to the heart after passively traversing the pulmonary capillary bed.
- Trial name
- NCT01971580
- Testing
- Ambrisentan
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Washington University School of Medicine
Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch
The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
Hypothesis: By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed…
- Conditions
- Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan Palliation
- Trial name
- NCT01971593
- Testing
- Eplerenone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Washington University School of Medicine
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
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