Clinical trials: Fontan
Fontan Procedure, Fontan Circulation
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
This is a multicenter, observational, cross-sectional study designed to investigate whether a parsimonious set of low-cost, accessible functional, anthropometric, and physiological measurements can help identify multisystem…
- Trial name
- NCT07874165
- Volunteers
- 150 people
- Sponsor
- Universidad de Murcia
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
Fontan Palliation
Upright Versus Supine Exercise Testing in Fontan-palliated Patients
Fontan-palliated patients comprise an interesting group of single-ventricle patients who are dependent upon passive return of blood from the body to the lungs.
- Trial name
- NCT00633815
- Testing
- Supine positioning, Upright positioning
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Congenital Heart Disease, Single Ventricle
Cardiovascular, Pulmonary and Skeletal Muscle Evaluation Postoperative in Fontan Patients: Effects of Exercise Training
Introduction: The Fontan operation is the surgical treatment in most patients with either anatomic or functional single ventricles.
- Conditions
- Congenital Heart Disease, Single Ventricle, Univentricular Heart
- Trial name
- NCT02283255
- Testing
- Aerobic Exercise Training, Inspiratory Muscle Training, No Exercise Training
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Fontan Operation
Pulmonary Functions Test in Patients After Fontan Operation
Developed in the early 1970s, Fontan Operation has provided palliative care for patients with single ventricle physiology. Single ventricle is a rare subclass of the atrioventricular (AV) alignment abnormalities double inlet and…
- Trial name
- NCT01413308
- Volunteers
- 15 people
- Sponsor
- Rambam Health Care Campus
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
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
Failure of Fontan Type Circulation, Fenestration
Occlutech AFR Fontan Study
The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation.
- Conditions
- Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly
- Trial name
- NCT07532369
- Testing
- Occlutech Atrial Flow Regulator Retrospective Data Collection
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Occlutech International AB
Functional Single Ventricle Heart Disease
A Extension Study of Udenafil in Adolescents
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart…
- Trial name
- FUELExten (NCT03013751)
- Testing
- Udenafil
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 301 people
- Sponsor
- Mezzion Pharma Co. Ltd
Congenital Heart Defect
The Effects of Inhaled Nitric Oxide After Fontan Operation
Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance.
- Trial name
- NCT00945529
- Testing
- inhaled nitric oxide (iNO)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Ellen Spurrier
Single-ventricle
Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will…
- Trial name
- NCT05634226
- Testing
- Hands-free oral-positive pressure device (oPEP)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Tarek Alsaied
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
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
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
Fontan Procedure, Congenital Heart Disease
Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients
This study will examine and record the patient's medical information and medical records (patient files, computer records, etc.). Physical examination, echocardiographic, electrocardiographic, laboratory, radiological, etc.
- Trial name
- NCT05684562
- Testing
- Cardiopulmonary exercise test, Pulmonary function test, Respiratory muscle strength test
- Where
- Turkey (Türkiye)
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction
Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease
This study evaluates whether new flow parameters of the cardiac magnetic resonance imaging (MRI) allow evaluation of parameters for which usually invasive rigth-left heart catheterization are necessary.
- Conditions
- Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction, Fontan Circulation
- Trial name
- NCT07742046
- Testing
- Right-left heart catheterization in magnetic resonance imaging (MRI)
- Where
- Switzerland
- Volunteers
- 130 people
- Sponsor
- Tobias Rutz
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
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
Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
Fluid Balance in Children Undergoing Fontan Surgery
This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure.
- Trial name
- NCT02306057
- Testing
- Pre BCPC, Pre TCPC, BCPC surgery
- Where
- Norway
- Volunteers
- 39 people
- Sponsor
- Oslo University Hospital