Clinical trials: Single Ventricle Heart Disease
Congenital Heart Disease
Endothelin Blockade in Patients With Single Ventricle Physiology
Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar…
- Trial name
- NCT00989911
- Testing
- Bosentan
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, Los Angeles
Arrhythmias, Atrial Fibrillation
Evaluation of a Single-lead ECG Patch-based Telemetry System for In-hospital Monitoring
"This investigator-initiated, prospective, single-center clinical study evaluates the performance and clinical utility of a single-lead electrocardiogram (ECG) patch-based telemetry system for hospitalized patients who require…
- Conditions
- Arrhythmias, Atrial Fibrillation, Ventricular Tachycardia, Supraventricular Tachycardia
- Trial name
- NCT07260721
- Testing
- MEMO-Cue-based telemetry monitoring
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University
Single Ventricle
Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
The purpose of this study is to test the efficacy of treprostinil (TRE) in the perioperative non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube drainage (in days).
- Trial name
- NCT02498444
- Testing
- Treprostinil
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Stanford University
mHealth, Adherence, Patient
Parental Experience in the Single Ventricle Interstage Utilizing a mHealth Innovation: A Comparative Case Study
The purpose of this study is to provide a rich description of the parental perspectives of utilizing a mHealth application for data transfer during the single ventricle interstage monitoring period.
- Trial name
- NCT03231020
- Testing
- Interview
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Children's Mercy Hospital Kansas City
Heart Failure, Ventricular Dysfunction
Effects of Nesiritide in Pediatric Patients With Heart Failure
Children with severe heart failure need immediate appropriate care. New and better drugs are constantly being developed. As these drugs are approved for adult use, they are used off-label for children.
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Decompensation
- Trial name
- NCT00166010
- Testing
- Nesiritide
- Sponsor
- Emory University
Irregular Heart Rate
Ventricular Synchrony in Pediatric Patients
At Children's Healthcare of Atlanta, children who have irregular heart rhythms are often referred for evaluation. Sometimes they also need a procedure to correct their irregular heart rhythm.
- Trial name
- NCT00165932
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- Emory University
Aortic Stenosis
Feasibility Study of the transShield Embolic Protection System
The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06652841
- Testing
- transShield Embolic Protection System
- Where
- New Zealand
- Volunteers
- 2 people
- Sponsor
- TransAortic Medical, Inc.
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
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
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
Hypoplastic Left Heart Syndrome
SVRII Family Factors Study
The purpose of this study is to learn about the relationship between family factors and developmental and psychosocial outcomes in children with congenital heart disease at 6 years of age.
- Trial name
- NCT01582529
- Where
- 11 sites in United States, Canada
- Volunteers
- 187 people
- Sponsor
- Medical College of Wisconsin
Ventricular Tachycardia
Initial Management of Patients Receiving a Single Shock (IMPRESS)
The goal of this study is to determine the optimal treatment for patients who receive a single shock from their implantable cardioverter defibrillator (ICD).
- Trial name
- IMPRESS (NCT03531502)
- Testing
- Ventricular Tachycardia Ablation, Standard Medical Therapy, Non-Invasive Programmed Stimulation (NIPS)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Saint Luke's Health System
Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Genetic Determinants of Congenital Heart Disease Outcomes
The purpose of this study is to examine the role of genetic variation in the oxidative stress response on critical perioperative and short-term outcomes after neonatal heart surgery.
- Conditions
- Congenital Heart Disease, Hypoplastic Left Heart Syndrome, Hypoplastic Right Heart Syndrome, d-Transposition of the Great Arteries
- Trial name
- GECHO (NCT01656941)
- Where
- 5 sites in United States, Australia
- Volunteers
- 250 people
- Sponsor
- University of Michigan
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Dopamine, Protein-Losing Enteropathies
Characterizing the Effect of Dopamine on Markers of Lymph Re-circulation in Fontan-associated Protein-losing Enteropathy
Patients that have undergone a Fontan procedure (surgical correction for single ventricle congenital heart disease) may develop a complication known as protein-losing enteropathy (PLE).
- Conditions
- Dopamine, Protein-Losing Enteropathies, Lymphatic System, Lymph
- Trial name
- NCT03322345
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Michigan
Single-ventricle
Fibrosis and the Fontan
The purpose of this study is to non-invasively characterize the fibrotic consequences of single ventricle physiology, its possible solution and effect on lymphatics.
- Trial name
- NCT04901975
- Testing
- Spironolactone
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Children's Hospital of Philadelphia
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
Pulmonary Embolism, Right Ventricular Dysfunction
Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE
SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2…
- Conditions
- Pulmonary Embolism, Right Ventricular Dysfunction, Right Ventricular Failure
- Trial name
- SONIC-PE (NCT06310018)
- Testing
- Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis, Tissue Plasminogen Activator
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brigham and Women's Hospital
Heart Failure Congenital, Single-ventricle
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life. 1.
- Trial name
- NCT06150950
- Testing
- Cardiac rehabilitation, Usual care
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Stanford University
Primary Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH
This is an open-label, single-armed, prospective single-centre clinical study to evaluate the effect of riociguat on right heart size and function in patients with manifest PAH and CTEPH.
- Trial name
- RIVERII (NCT04954742)
- Testing
- Riociguat
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Heidelberg University