Clinical trials: Single-ventricle Physiology
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
Aortic Stenosis Symptomatic
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
- Trial name
- NCT06721676
- Testing
- transcatheter aortic valve replacement in severe aortic stenosis
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Heart Failure
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in…
- Trial name
- ADMIRE-ICD (NCT02656329)
- Testing
- Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator, Thyroid blocking
- Where
- 94 sites in United States, Canada and 8 more
- Volunteers
- 395 people
- Sponsor
- GE Healthcare
Heart Disease, Congenital, Single Ventricle
Single Ventricle Outcome
The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.
- Conditions
- Heart Disease, Congenital, Single Ventricle, Hypoplastic Left Heart Syndrome
- Trial name
- NCT00308217
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Emory University
Single-ventricle
Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
This study is testing whether a special formula called Fortini, which is a high-calorie, low osmolality formula can help high-risk babies with single ventricle physiology grow better after their initial Stage 1 surgical…
- Trial name
- NCT07087782
- Testing
- Fortini formula, Standard Nutritional Care
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Driscoll Children's Hospital
Congenital Heart Disease
Pulmonary Capillary Recruitment in Fontan Patients
This study evaluates the effects of pulmonary vasodilator therapy on pulmonary capillary blood flow by measuring the functional capillary surface area (FCSA) at baseline and post nitric oxide inhalation, through the injection of…
- Trial name
- NCT04292483
- Testing
- Nitric Oxide
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- Jewish General Hospital
Pulmonary Arterial Hypertension
A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension
The primary objective of this study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in…
- Trial name
- ARTISAN (NCT05203510)
- Testing
- Parenteral Treprostinil, Oral Treprostinil
- Where
- 28 sites in United States
- Volunteers
- 52 people
- Sponsor
- United Therapeutics
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
Diabetes Mellitus, Type 2, Diastolic Dysfunction
Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Type 2 Diabetics
The purpose of the EmDia trial is to compare the effects of empagliflozin with placebo in addition to standard diabetic treatment or dietetic treatment on cardiac diastolic function in patients with type 2 Diabetes mellitus.
- Trial name
- EmDia (NCT02932436)
- Testing
- Empagliflozin
- Where
- Germany
- Volunteers
- 144 people
- Sponsor
- Johannes Gutenberg University Mainz
Congenital Heart Defect
Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following…
- Trial name
- NCT02860702
- Testing
- Human Milk Derived Fortifier, Human/Bovine Milk
- Where
- 12 sites in United States
- Volunteers
- 16 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Congenital Disorders
Spironolactone in Patients With Single Ventricle Heart
Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions.
- Trial name
- NCT00211081
- Testing
- Spironolactone (drug)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Emory University
Comparison of 3D Monitored Changes of Left Atrial Volume Before and After Ablation With Conventional Transesophageal Echocardiography
Assessment of Left Atrial Mechanical Function With a True 3D Ultrasouns Arry and Comparison With the Transthoracic and Transesophageal Echocardiography
Chronic atrial fibrillation is a challenging arrhythmia requiring additional radiofrequency ablation besides pulmonary vein isolation. Atrial contractility in these patients is often impaired.
- Trial name
- NCT03331029
- Testing
- transesophageal investigation
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Klinik Hirslanden, Zurich
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
Congenital Heart Disease
International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease
The international multicenter registry aims to collect real-world data on clinical outcomes and evaluate the net clinical success of transcatheter microvascular plug (MVP)-based pulmonary flow restrictors (PFRs) in patients with…
- Trial name
- RESTRICT (NCT07791069)
- Testing
- Transcatheter pulmonary flow restriction
- Where
- 5 sites in France, Germany and 3 more
- Volunteers
- 150 people
- Sponsor
- Fondation Hôpital Saint-Joseph
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
Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates…
- Conditions
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Single Ventricle Defect, Stress, Psychological
- Trial name
- NCT02462434
- Testing
- Early palliative care team consultation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
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
Pulmonary Arterial Hypertension PAH, Pulmonary Arterial Hypertension WHO Group I
Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE)
Pulmonary arterial hypertension (PAH) is a progressive disease characterized by vascular remodelling resulting in elevated pressures in the pulmonary artery (PA).
- Conditions
- Pulmonary Arterial Hypertension PAH, Pulmonary Arterial Hypertension WHO Group I, Pulmonary Arterial Hypertension
- Trial name
- RECOMPENSE (NCT06658522)
- Testing
- Sotatercept
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Amsterdam UMC, location VUmc
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
Acute Myocardial Infarction, Pulmonary Hypertension
Pulmonary Hypertension on Prognosis of Acute Myocardial Infarction Patients With Reduced Left Ventricular Function
Pulmonary hypertension (PH) has a negative effect on acute myocardial infarction (AMI) patients and appears to be closely associated with reduced left ventricular function.
- Trial name
- STIMULATE (NCT06186713)
- Testing
- This was an observational study, and no Intervention was given to the patients.
- Where
- China
- Volunteers
- 4,784 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University