Clinical trials: Fontans
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 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
Fontan Circulation
Muscle Function in Patients With Single-chamber Heart
Groundbreaking cardiac surgery has significantly improved survival rates for patients with single-chamber hearts. However, despite these life-saving interventions, the long-term prognosis remains concerning, with an increased…
- Trial name
- Muscle in TCPC (NCT07420660)
- Where
- Sweden
- Volunteers
- 34 people
- Sponsor
- Karolinska Institutet
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
Fontan, Heart Failure
The Effect of Dapagliflozin on Exercise and Cardiac Functional Status of Patients After Fontan Procedure
While the Fontan operation improves survival for patients with a functional single ventricle, complications like heart failure remain prevalent during follow-up, causing frequent hospitalizations and reduced quality of life.
- Conditions
- Fontan, Heart Failure, Dapagliflozin, Cardiovascular Diseases
- Trial name
- NCT07482943
- Testing
- Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy
- Where
- 2 sites in Hong Kong
- Volunteers
- 30 people
- Sponsor
- The University of Hong Kong
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
Prevention of Venous Thromboembolism, Congenital Heart Disease
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery…
- Conditions
- Prevention of Venous Thromboembolism, Congenital Heart Disease, Fontan Procedure, Children
- Trial name
- NCT06193863
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 61 people
- Sponsor
- Bayer
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
Fontans
Fontan Associated Liver Disease
Fontan-associated liver disease (FALD), including the development of cardiac cirrhosis and liver neoplasms (benign and malignant), occurs in a majority of patients with congenital heart disease palliated with the Fontan…
- Trial name
- NCT03914196
- Testing
- Liver Stiffness Ultrasound
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Fontan Circulation
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.
- Trial name
- IMPROVE-FALD (NCT06324396)
- Testing
- Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg), Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Mercy Hospital Kansas City
Congenital Heart Surgery, Congenital Heart Disease in Children
Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.
Patients younger than 18 scheduled for congenital heart surgery will be assessed during and post-operatively as well as at the first follow-up after 9-12 month for the novel biomarker sST2.
- Conditions
- Congenital Heart Surgery, Congenital Heart Disease in Children, Fontan Physiology
- Trial name
- NCT07029230
- Where
- Switzerland
- Volunteers
- 225 people
- Sponsor
- Martin Schweiger
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
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
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
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