Clinical trials: Single-ventricle
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
Ventricular Repolarization
A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects
This study is conducted to evaluate the effectiveness of DIC075V on ventricular repolarization in healthy subjects compared to placebo after a single dose of DIC075V administered intravenously (IV) and to evaluate ECG assay…
- Trial name
- NCT01812538
- Testing
- DIC075V
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Congenital Heart Disease, Nutritional Failure
Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
The purpose of this study is to understand the causes of growth failure and to define biochemical markers of nutritional failure in patients with single ventricle Congenital Heart Disease (CHD).
- Trial name
- NCT01821287
- Testing
- CHD
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Left Ventricular Dysfunction, Ventricular Dysfunction
Low Ejection Fraction in Single Lead ECG- Ochsner
The purpose of this research is to prospectively test and validate the single-lead Low EF algorithm in outpatients in order to test the performance of a single-lead ECG based algorithm to identify people with decreased left…
- Conditions
- Left Ventricular Dysfunction, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT05010642
- Testing
- Use of Eko DUO electronic Stethoscope
- Where
- United States
- Volunteers
- 307 people, healthy volunteers welcome
- Sponsor
- Eko Devices, Inc.
Healthy Chinese Subjects
A Study of Etripamil in Healthy Subjects
The objectives of the study are as below: Primary: ·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects Secondary: To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese…
- Trial name
- NCT05511870
- Testing
- Etripamil Nasal Spray 70mg
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Corxel Pharmaceuticals
Healthy Participants
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.
- Trial name
- NCT05719805
- Testing
- Mavacamten
- Where
- 2 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Single-ventricle, Myocardial Fibrosis
Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient
This is a single center prospective longitudinal exercise training study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years.
- Trial name
- NCT03263312
- Testing
- Exercise
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Maria Bano
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
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
Hypoxia, Normobaric Hypoxia
Effect of Acute Hypoxia on RIght VEntRicular Function in Healthy Adults.
More and more people are engaging in sports in the mountains, including individuals with heart or lung diseases. At the same time, such diseases are becoming more common in Switzerland.
- Conditions
- Hypoxia, Normobaric Hypoxia, Altitude Hypoxia, Right Heart Function
- Trial name
- RIVER-H (NCT07431567)
- Testing
- Normobaric Hypoxia
- Where
- 2 sites in Switzerland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Mona Lichtblau
Congenital Heart Disease
SVR III: Brain Connectome and Neurodevelopmental Outcomes
Patients with hypoplastic left heart syndrome and other single right ventricle lesions who have undergone the Fontan procedure have a high risk of neurodevelopmental disorders that affect quality of life and adulthood employment.
- Trial name
- SVRIII (NCT02692443)
- Testing
- Magnetic Resonance Imaging, Neurodevelopmental Testing
- Volunteers
- 223 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Healthy Volunteer
Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults
The primary objective of Part 1 of the study is to evaluate the safety and tolerability of S-648414 after administration of a single oral dose of S-648414 in healthy adult study participants.
- Trial name
- NCT04147715
- Testing
- S-648414, Midazolam, Dolutegravir
- Where
- 2 sites in United States, Japan
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Shionogi
Quantitative Validation for Ventricular SPECT Imaging
Validation of Quantitative Ventricular Function Imaging Single Photon Emission Tomography (Spect)Using the D-SPECT Cardiac Camera
The purpose of this study is to validate the use of DSPECT camera for the performance of quantitative spect ventricular function imaging by comparison to a validated procedure performed on standard nuclear cameras.
- Trial name
- NCT01296737
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Spectrum Dynamics
Single-ventricle, Congenital Heart Disease
Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex.
- Trial name
- VU3D (NCT05118152)
- Where
- France
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
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
Stroke, Aortic Valve Stenosis
INTERvention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi)
The study aims to evaluate the processes of a pilot single-centre randomised controlled trial (RCT) of carbon-dioxide flushing of transcatheter aortic valves (TAVI-CO2) versus standard saline flushing of valves (TAVI-S) and…
- Conditions
- Stroke, Aortic Valve Stenosis, Silent Cerebral Infarct, Vascular Brain Injury
- Trial name
- INTERCEPTavi (NCT05146037)
- Testing
- CO2 and saline flushing, Saline flushing
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Diastolic Function
Determination of Diastolic Dysfunction by Single Lead Electrocardiogram
It is a prospective, controlled, single-center, non-randomized, observational study. From September 2019 to December 2020, the study plans to prospectively include 400 patients aged 18 to 90 years.
- Trial name
- NCT04474639
- Testing
- echocardiographic examination
- Where
- Russia
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Pulmonary Hypertension, Heart Failure
Frailty in Children With Cardiac Disease
Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to decreased resistance to stressors and is associated with adverse health outcomes.
- Conditions
- Pulmonary Hypertension, Heart Failure, Single Ventricle
- Trial name
- NCT02999438
- Testing
- Actigraph to check activity levels at home
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
Cicatrix
Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions
This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.
- Trial name
- NCT00627536
- Testing
- Avotermin
- Where
- United Kingdom
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Renovo
Fontan Procedure, Hypoplastic Left Heart Syndrome
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia
- Trial name
- NCT00974025
- Testing
- Vitamin C
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Michigan