Clinical trials: Single-ventricle Fontan
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
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
Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
Randomisation between postoperative administration of an ACE-inhibitor or not.
- Trial name
- NCT00263406
- Testing
- Administration of an ACE-inhibitor or not
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- University Hospital, Ghent
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
Univentricular Heart, Lymphatic Abnormalities
Lymphatic Function in Patients With a Fontan Circulation From Brazil
It is suggested that the elevated central venous pressure in patients with a Fontan circulation can provoke manifestation of lymphatic dysfunction, met as plastic bronchitis, peripheral oedema and most feared protein-losing…
- Conditions
- Univentricular Heart, Lymphatic Abnormalities, Lymphatic Edema
- Trial name
- NCT04394507
- Testing
- Near-Infrared Fluorescence imaging, Strain Gauge Plethysmography
- Where
- 2 sites in Denmark
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Univentricular Heart
Aesculus Hippocastanum L. on Fontan Circulation
Patients after the Fontan operation at a single institution will be randomized to receive a standardized extract of Aesculus hippocastanum L. (horse chestnut) or placebo for 4 months in a crossover clinical trial.
- Trial name
- NCT04035317
- Testing
- Aesculus Hippocastanum / Horse Chestnut
- Where
- Brazil
- Sponsor
- Casa Espirita Terra de Ismael
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 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 Procedure, Hypoplastic Left Heart Syndrome
Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Double Inlet Left Ventricle
- Trial name
- NCT01107990
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Tricuspid Atresia, Heart Defects, Congenital
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure. II.
- Trial name
- NCT00004828
- Testing
- liothyronine I 131
- Volunteers
- 28 people
- Sponsor
- FDA Office of Orphan Products Development
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
Tricuspid Atresia, Hypoplastic Left Heart Syndrome
Biomarker Study for Heart Failure in Children With Single Ventricle Physiology
The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.
- Conditions
- Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Unbalanced AV Canal
- Trial name
- BHFSVP (NCT00571233)
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- University of California, San Francisco
Single-ventricle, Hepatic Congestion
The Effect of Fontan Fenestration Closure on Hepatic Stiffness
The overarching goal of this project is to discern how closure of Fontan fenestrations in patients with single ventricle heart disease will affect hepatic congestion, a major determinant of chronic liver disease.
- Trial name
- NCT03481985
- Testing
- Fenestration status
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Boston Children's Hospital
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, Frailty
WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of…
- Conditions
- Fontan Physiology, Frailty, Single Ventricle Heart Disease
- Trial name
- NCT05199857
- Testing
- WE BEAT Group Wellness Education program - phase 1, HEART Club Home Exercise program - phase 2
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Michigan
Congenital Heart Disease, SRV Dependent
Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD
Researchers want to better understand what happens to the heart when the autologous (from one's own body) stem cells are injected directly into muscle of the right side of the heart during the Fontan (Stage III) surgery.
- Trial name
- NCT04907526
- Testing
- Autologous mononuclear cells
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Timothy J Nelson, MD, PhD
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
Congenital Heart Disease
Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects
Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.
- Trial name
- NCT02378857
- Where
- Norway
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Oslo University Hospital
Complex Congenital Heart Disease, Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass
Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease
An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance. There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an…
- Conditions
- Complex Congenital Heart Disease, Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass, Systemic Right Ventricle, Pulmonary Failure
- Trial name
- CAR-DIFF (NCT02561975)
- Testing
- Double pulmonary diffusing
- Where
- France
- Volunteers
- 33 people
- Sponsor
- University Hospital, Montpellier