Clinical trials: Cardiac Congenital Defects
Congenital Heart Disease
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.
- Trial name
- NCT00848250
- Testing
- Angiotensin Converting Enzyme Inhibitor, No ACE Inhibitor
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Vanderbilt University Medical Center
Foramen Ovale, Patent, Heart Catheterization
Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the interatrial septum is a clinical finding…
- Conditions
- Foramen Ovale, Patent, Heart Catheterization, Heart Septal Defects, Atrial
- Trial name
- 09k003 (NCT00968032)
- Testing
- Nit-Occlud® PFO
- Where
- Germany
- Volunteers
- 63 people
- Sponsor
- pfm medical gmbh
Congenital Heart Disease
Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery
The investigators hypothesize that intermittent bolus doses of morphine and midazolam can provide the same pain control after pediatric cardiothoracic surgery as bolus doses plus infusions while using smaller total doses of both…
- Trial name
- NCT02112448
- Testing
- continuous infusion, as needed dosing, Acetaminophen
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Wake Forest University Health Sciences
Adult Rhabdomyosarcoma, Lung Metastases
Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases
This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating younger patients with lung metastases.
- Conditions
- Adult Rhabdomyosarcoma, Lung Metastases, Metastatic Ewing Sarcoma, Previously Treated Childhood Rhabdomyosarcoma
- Trial name
- NCT01586104
- Testing
- intensity-modulated radiation therapy
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Myocardial Bridging
Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging
The proposed clinical trial is relevant to public health because it is expected to expand the differential diagnosis and provide an evidence--based therapy for the large population of patients with angina in the absence of…
- Trial name
- NCT04130438
- Testing
- Nebivolol, Diltiazem
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Stanford University
Congenital Heart Defect, Surgery-Induced Tissue Adhesions
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and…
- Conditions
- Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage
- Trial name
- NCT01330433
- Testing
- CoSeal Surgical Spray Group
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Loma Linda University
Ventricular Tachycardia, Ventricular Fibrillation
Pediatric Lead Extractability and Survival Evaluation (PLEASE)
This is a randomized, prospective clinical trial comparing 2 different types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Long QT Syndrome
- Trial name
- NCT00335036
- Testing
- ICD lead implant, Thin leads
- Where
- United States
- Volunteers
- 748 people
- Sponsor
- Charles Berul
Cardiac Disease
Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)
The purpose of this study is to determine whether long-term treatment with a beta-blocker (BB) such as atenolol and/or an angiotensin receptor blocker (ARB) such as telmisartan, given to adult patients with bicuspid aortic valve…
- Trial name
- BAV (NCT01202721)
- Testing
- Atenolol, Telmisartan
- Where
- 13 sites in Canada
- Volunteers
- 85 people
- Sponsor
- Hamilton Health Sciences Corporation
Williams Beuren Syndrome
Efficacy of Minoxidil in Children With Williams-Beuren Syndrome
The Williams-Beuren syndrome (WBS) is a sporadic congenital disorder characterized by a multisystem developmental impairment. This syndrome is caused by a microdeletion in chromosome 7q11.23 that encompasses loss of the elastin…
- Trial name
- Williams (NCT00876200)
- Testing
- Minoxidil
- Where
- 18 sites in France
- Volunteers
- 21 people
- Sponsor
- Hospices Civils de Lyon
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in participants with ATTR amyloidosis with cardiomyopathy.
- Trial name
- NCT04153149
- Testing
- Vutrisiran, Sterile Normal Saline (0.9% NaCl)
- Where
- 119 sites in United States, Argentina and 30 more
- Volunteers
- 655 people
- Sponsor
- Alnylam Pharmaceuticals
Pulmonary Arterial Hypertension, Congenital Heart Disease
Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease
Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is common in patients with congenital heart disease.
- Conditions
- Pulmonary Arterial Hypertension, Congenital Heart Disease, Eisenmenger's Syndrome
- Trial name
- NCT01319045
- Testing
- Iloprost
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of California, Los Angeles
Pulmonary Arterial Hypertension
Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.
- Trial name
- MAESTRO (NCT01743001)
- Testing
- Macitentan 10 mg
- Where
- 55 sites in United States, Austria and 19 more
- Volunteers
- 226 people
- Sponsor
- Actelion
Kawasaki Disease
Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery…
- Trial name
- NCT02179853
- Testing
- Anakinra
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of California, San Diego
Amyloidosis, Amyloid Cardiomyopathy
Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy
Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
- Conditions
- Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis, Cardiomyopathies
- Trial name
- ATTRibute-CM (NCT03860935)
- Testing
- acoramidis
- Where
- 104 sites in United States, Australia and 16 more
- Volunteers
- 632 people
- Sponsor
- Eidos Therapeutics, a BridgeBio company
Single Ventricle Physiology
Training in Exercise Activities and Motion for Growth
To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
- Trial name
- T4G (NCT01917084)
- Testing
- Passive range of motion (ROM) exercise
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Carelon Research
Low T3 Syndrome
Can Oral T3 Normalize Thyroid Hormone Levels Following Cardiopulmonary Bypass in Children?
Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill. This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary bypass.
- Trial name
- NCT01780584
- Testing
- Oral T3 Low dose, Oral T3 high dose
- Where
- Indonesia
- Volunteers
- 45 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Stillbirth, Neonatal Death
Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda
A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital…
- Trial name
- NCT02273037
- Testing
- Fetal heart rate Doppler, Partograph
- Where
- 2 sites in Canada, Uganda
- Volunteers
- 1,987 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Hypoplastic Left Heart Syndrome, Hypoplastic Right-sided Heart Complex
Ambrisentan in Single Ventricle
Purpose: To evaluate the pharmacokinetics, bioavailability and hemodynamic efficacy of ambrisentan after Fontan surgical palliation of single ventricle heart defects.
- Trial name
- NCT02080637
- Testing
- Ambrisentan
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Kevin Hill
Heart Defects, Congenital
Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
The staged surgical pathway to treat children with single ventricle heart defects culminates with the Fontan operation. In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to…
- Trial name
- NCT00543309
- Testing
- nesiritide, milrinone
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- John M Costello
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