Clinical trials: Congenital Heart Disease With Fontan Circulation
Single-ventricle, Congenital Heart Disease
Fontan Fitness Trial
The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention.
- Trial name
- NCT06918795
- Testing
- Digital Exercise Intervention
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Philadelphia
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
Congenital Heart Disease, Univentricular Heart
Effect of Muscle Strengthening Training in Adults with Fontan Circulation
Aim: to evaluate the effect of muscle strengthening exercise training in adults with Fontan circulation compared to healthy controls.
- Trial name
- NCT05454254
- Testing
- Individualised muscle strengthening exercise training protocol.
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- Umeå University
Lymphatic Abnormality, Plastic Bronchitis
Lymphatic Morphology of Fontan Patients
The Fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. However, over time, it is associated with severe lymphatic complications such as plastic bronchitis…
- Conditions
- Lymphatic Abnormality, Plastic Bronchitis, Protein-Losing Enteropathies, Univentricular Heart
- Trial name
- NCT04163653
- Testing
- Non-contrast MRI, Cardiopulmonary exercise test
- Where
- Denmark
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
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
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
Congenital Heart Disease
Impact of a Cardiac and Mental Health Rehab Program on Well-Being and Fitness in Young Adults With Fontan Circulation: A Randomized Trial
Helping Young Adults With Fontan Circulation Feel Better and Stay Active What is the study about? This study looked at how a special program could help young adults with Fontan circulation feel better mentally and physically.
- Trial name
- (NCTXXXXXXXX) (NCT06844149)
- Testing
- CPR; (Cardiac and Psychosocial Rehabilitation) with Cardiac Rehabilitation, CR; Home-Based Cardiac Rehabilitation, Usual Care
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Samsung Medical Center
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, Microvascular Dysfunction
Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation
Univentricular heart (UVH) is a severe congenital heart disease. Accurate advanced non-invasive diagnostic methods is limited. Cardiovascular magnetic resonance (CMR) imaging has evolved as a particularly useful tool for the…
- Conditions
- Univentricular Heart, Microvascular Dysfunction, Heart Failure, Magnetic Resonance
- Trial name
- CMR_TCPC (NCT06735521)
- Testing
- Cardiac magnetic resonance stress-perfusion
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Karolinska Institutet
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
Univentricular Heart, Congenital Heart Disease
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
Background: The Fontan operation has been used to treat complex cardiac anomalies with a single-functioning ventricle. A study performed by Instituto do Coracão-Hospital das Clínicas-Universidade de Sao Paulo…
- Conditions
- Univentricular Heart, Congenital Heart Disease, Lymphatic Abnormalities, Functional Capacity
- Trial name
- NCT05934578
- Testing
- Exercise training
- Where
- Brazil
- Volunteers
- 20 people
- Sponsor
- University of Sao Paulo
Heart Defects, Congenital
Colloid Osmotic Pressure in Patients With Fontan Circulation
Children born with univentricular heart will go through step surgery and end up with a Fontan circulation. A circulation with cause problems with body fluid balance.This project will evaluate changes in interstitial colloid…
- Trial name
- NCT02443662
- Testing
- Catheterization
- Where
- Norway
- Volunteers
- 12 people
- Sponsor
- Oslo University Hospital
Single-ventricle, Congenital Heart Disease
Enhanced External Counterpulsation in Patients With Fontan Circulation
The purpose of the proposed study is to determine the safety of enhanced external counterpulsation (EECP), a system for compressing the blood vessels in the legs in synchrony with an individual's cardiac rhythm, in clinically…
- Trial name
- NCT04956952
- Testing
- EECP
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Boston Children's Hospital
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
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
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 (CHD), Univentricular Heart
Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
This prospective cohort study evaluates differences in clinical outcomes between pulmonary oligemia and pulmonary plethora in patients with cyanotic congenital heart disease and univentricular heart physiology undergoing staged…
- Trial name
- NCT07535203
- Testing
- Fontan Procedure
- Where
- Indonesia
- Volunteers
- 52 people
- Sponsor
- Sisca Natalia Siagian
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
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