Clinical trials: Fontan Circulation
Single-ventricle
Inspiratory Muscle Therapy in Subjects With Fontan Circulations
Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory mechanics to support pulmonary blood flow (PBF).
- Trial name
- NCT03339466
- Testing
- Inspiratory muscle therapy
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Congenital Heart Disease
SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure
Some people are born with a birth defect where they only have one functioning ventricle (lower chamber) in their heart. This condition can be initially managed with a Fontan operation, but there is a risk of developing Fontan…
- Trial name
- EMPA-HEART-3 (NCT06955260)
- Testing
- Empagliflozin 10 mg
- Where
- 2 sites in Canada
- Volunteers
- 410 people
- Sponsor
- Subodh Verma
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 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
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 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
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 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 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
Patient Participation, Heart Defects, Congenital
Liver Disease, Myocardial Fibrosis and Collaterals in the Adult Fontan Patient a Metabolomics and Proteomics Approach
Out objective is to identify the mechanisms that promote hepatic and myocardial fibrosis, and collateral vessel formation in patients with complex congenital heart disease and Fontan circulation.
- Conditions
- Patient Participation, Heart Defects, Congenital, Liver Diseases, Collateral Circulation, Any Site
- Trial name
- NCT04764305
- Where
- Austria
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck
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
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, Fontan Circulation
Venous Compression in Fontan
The aim of this study is to investigate whether venous compression garments increase exercise stroke volume in patients with Fontan circulation. To address this aim, we will test the following hypotheses: 1.
- Trial name
- NCT07220226
- Testing
- Lower extremity compression garments, Without compression garments
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
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
Congenital Heart Disease
Fontan Patients: Comprehensive Evaluation of Pulmonary Circulation and Ventricular Function
In patients with one anatomical or functional ventricular chamber, which encompasses a spectrum of rare and complex congenital cardiac malformations, a staged surgical approach in view of an ultimate Fontan operation has become…
- Trial name
- NCT01572363
- Testing
- Sildenafil
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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
Lymphatic Abnormalities, Lymphatic Edema
Lymphatic Function in Patients With a Fontan-Kreutzer Circulation
The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema.
- Conditions
- Lymphatic Abnormalities, Lymphatic Edema, Univentricular Heart
- Trial name
- NCT03379805
- Testing
- Near Infrared Fluorescence Imaging, Non-contrast MRI, Strain Gauge Plethysmography
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Fontan Physiology, Frailty
Home Exercise And Resiliency Training (Heart) Club
The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine…
- Trial name
- NCT05543733
- Testing
- Home exercise program
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- University of Michigan
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
Fontan Circulation, Single Ventricle Heart Disease
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.
- Conditions
- Fontan Circulation, Single Ventricle Heart Disease, HFpEF - Heart Failure With Preserved Ejection Fraction
- Trial name
- NCT06762964
- Testing
- Dapagliflozin tablet
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Mayo Clinic