Clinical trials: Fontan
Hypotension, Fontan Physiology
The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology
The goal of this study is to evaluate if vasopressin can elevate systemic arterial blood pressures without having a significant effect on pulmonary arterial pressures.
- Trial name
- NCT04463394
- Testing
- Vasopressin
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Stanford University
Fontan Physiology
Effects of Different Tidal Volume Ventilation Strategies on Fontan Flow and Hemodynamics
In patients with Fontan circulation blood is not pumped to the lungs from a ventricle. Instead the superior vena cava and inferior vena cava is connected to the pulmonary artery and blood flow to the lungs occurs passively along…
- Trial name
- NCT04633343
- Testing
- Small volume breath and fast breathing rate for 5 minutes, Large volume breath and slow breathing rate for 5 minutes
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
Single Ventricle Heart Disease After Fontan Surgery
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular…
- Trial name
- NCT02201342
- Testing
- Udenafil
- Where
- 6 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Mezzion Pharma Co. Ltd
Fontan Operation, Protein-Losing Enteropathy
Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation
This study is phase 2 open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of Camostat mesylate in patients with Protein-losing enteropathy after Fontan operation.
- Conditions
- Fontan Operation, Protein-Losing Enteropathy, Camostat Mesylate
- Trial name
- NCT05474664
- Testing
- Camostat mesylate
- Where
- South Korea
- Volunteers
- 19 people
- Sponsor
- Seoul National University Hospital
Fontan Circulation
Fontan Circulation and Reproductive Health in a National Swedish Cohort
In the Swedish registry for congenital heart defects, SWEDCON, over 230 patients with single-ventricle circulation are registered in the adult section.
- Trial name
- NCT06258382
- Testing
- Questionnaires and functional test
- Where
- 15 sites in Sweden
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Caroline Lilliecreutz
Fontan Circulation
Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation.
This is the first pilot study proposing a novel therapeutic option treating patients with Fontan circulation (FC), a high-risk condition that has no definite treatment options available, other than heart or heart-liver…
- Trial name
- MYSTIC (NCT06197763)
- Testing
- Colesevelam, Control Arm
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- St. Boniface Hospital
Single-ventricle, Fontan Procedure
Hemodynamic, Vascular and Muscular Parameters of Exercise Capacity in Single-Ventricle Patients With Fontan Procedure
After the Fontan procedure applied in patients with a functional or anatomical single ventricle, patients are faced with significant morbidity and mortality risk.
- Conditions
- Single-ventricle, Fontan Procedure, Hemodynamic Instability, Arterial Stiffness
- Trial name
- NCT05011565
- Testing
- Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function
- Where
- Turkey (Türkiye)
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Congenital Heart Disease, Fontan Operation
The Role of the Pulmonary Vasculature in the Fontan Circulation
This study aims to explore the structural and functional characteristics of the pulmonary vasculature in adult Fontan patients. Objectives: Determine the effect of pulmonary vasodilatation on indexed cardiac output during…
- Conditions
- Congenital Heart Disease, Fontan Operation, Pulmonary Vascular Resistance, Pulmonary Vascular Remodeling
- Trial name
- NCT02414321
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- University Medical Center Groningen
Fontan Procedure
Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles
Evaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low preoperative risk profiles in prospective study
- Trial name
- NCT03503032
- Testing
- Extracardiac Fontan, Fontan fenestration
- Where
- Saudi Arabia
- Volunteers
- 62 people
- Sponsor
- King Faisal Specialist Hospital & Research Center
Congenital Heart Disease With Fontan Circulation
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study…
- Trial name
- RUBATO OL (NCT03775421)
- Testing
- macitentan 10 mg
- Where
- 19 sites in United States, Australia and 9 more
- Volunteers
- 112 people
- Sponsor
- Actelion
Fontan Procedure
Cholate Clearance in Fontans
HepQuant is an assay to measure liver function in other forms of liver disease such as hepatitis C. It measures the ability of the liver to process an naturally occurring substance called cholate and has been shown to predict…
- Trial name
- NCT03726229
- Testing
- Cholate assay
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Pennsylvania
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
Fontan
Nitrate Effect on Exercise Capacitance
The investigators will investigate the safety and preliminary efficacy of ISDN therapy to reduce venous congestion and improve exercise tolerance in children and adults after the Fontan operation.
- Trial name
- NEET (NCT04297241)
- Testing
- Isosorbide Dinitrate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Fontan
TRPV2 Agonists in the Fontan Circulation
There are currently very few proven pharmacologic options available for these patients. The recent discovery of transient receptor potential vanilloid (TRPV) channels, particularly TRPV2 channels, in the cardiovascular system is…
- Trial name
- NCT03965351
- Testing
- Probenecid
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Atrial Septal Defect, Patent Foramen Ovale
Canadian Adult Congenital Heart Disease Intervention Registry
The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of…
- Conditions
- Atrial Septal Defect, Patent Foramen Ovale, Tetralogy of Fallot, Fontan
- Trial name
- C-ACHDiR (NCT04288596)
- Testing
- Participants undergoing ACHD intervention
- Where
- Canada
- Volunteers
- 9,000 people
- Sponsor
- University Health Network, Toronto
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
Failing Fontan Physiology, Pediatric Congenital Heart Disease
Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
The purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with Fontan failure using…
- Trial name
- NCT03223168
- Testing
- Hayek RTX ventilator
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Michigan
Fontan Circulation
The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.
- Trial name
- NCT00964782
- Testing
- Sildenafil, Sildenafil 2
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Milton S. Hershey Medical Center
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