Clinical trials: Pediatric Heart Failure
Heart Failure, Left Ventricular Systolic Dysfunction
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period.
- Trial name
- NCT05714085
- Testing
- Vericiguat tablet, Vericiguat suspension
- Where
- 111 sites in United States, Belgium and 28 more
- Volunteers
- 342 people
- Sponsor
- Merck Sharp & Dohme LLC
Pediatric HD
EXCOR® Pediatric VAD Anticoagulation IDE
The Berlin Heart EXCOR ventricular assist device received approval from the FDA as a bridge to transplantation for children in 2011.
- Trial name
- NCT03702192
- Testing
- novel anticoagulation protocol used in conjunction with the Berlin Heart EXCOR
- Sponsor
- David N. Rosenthal
Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia, Acute Respiratory Failure, Acute Lung Injury
- Trial name
- PETIT (NCT06750536)
- Testing
- MiniLung petite kit combined with the Xenios console
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Xenios AG
Pediatric Heart Failure
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure
This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696.
- Trial name
- NCT02678312
- Testing
- LCZ696, Enalapril
- Where
- 98 sites in United States, Argentina and 27 more
- Volunteers
- 393 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
This is a single-center, non-randomized study.The study staff will use the InSpectraTM tissue oxygen saturation (StO2) monitor manufactured by Hutchinson Technology to measure baseline StO2 levels after applying the noninvasive…
- Trial name
- NCT02368041
- Testing
- InSpectraTM StO2 monitor
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- University of Florida
Congestive Heart Failure
Study to Evaluate the Safety of Twice Daily Oral Carvedilol
The objective of this study is to evaluate the long-term safety of carvedilol in pediatric patients with chronic heart failure, who completed the Pediatric Carvedilol Study 321.
- Trial name
- NCT00129363
- Testing
- Carvedilol
- Where
- 17 sites in United States
- Volunteers
- 75 people
- Sponsor
- Shaddy, Robert, M.D.
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the…
- Trial name
- NCT00583661
- Testing
- EXCOR Pediatric
- Where
- 17 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Berlin Heart, Inc
Renal Insufficiency, Acute
NIRS for the Diagnosis and Prevention of Acute Renal Failure
This prospective study will take place at Hotel Dieu de France hospital in Lebanon. One hundred children undergoing cardiac surgery for congenital heart disease between May 2020 and May 2021 will be included.
- Trial name
- NCT04605705
- Testing
- Optimization of the cardiac output, the temperature, the hemoglobin in order to have the NIRS value by up to 80%.
- Where
- Lebanon
- Volunteers
- 100 people
- Sponsor
- Saint-Joseph University
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
- Trial name
- NCT03255226
- Testing
- Tolvaptan
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Heart Failure, Cardiomyopathies
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.
- Conditions
- Heart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart Diseases
- Trial name
- E-Motion (NCT04634708)
- Testing
- No intervention
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Berlin Heart GmbH
Heart Failure, Respiratory Failure
Heart And Lung Failure - Pediatric INsulin Titration Trial
Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels, is often seen in critically ill patients.
- Trial name
- HALF-PINT (NCT01565941)
- Testing
- Insulin
- Where
- 35 sites in United States, Australia and 1 more
- Volunteers
- 713 people
- Sponsor
- Boston Children's Hospital
Congenital Heart Surgery, Congenital Heart Disease in Children
Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.
Patients younger than 18 scheduled for congenital heart surgery will be assessed during and post-operatively as well as at the first follow-up after 9-12 month for the novel biomarker sST2.
- Conditions
- Congenital Heart Surgery, Congenital Heart Disease in Children, Fontan Physiology
- Trial name
- NCT07029230
- Where
- Switzerland
- Volunteers
- 225 people
- Sponsor
- Martin Schweiger
Myocarditis
Myocarditis Registry for Children and Adolescents - MYKKE
MYKKE is a prospective multi-center registry for children and adolescents with myocarditis. The aim is to generate prospective multi-center data on epidemiology, diagnostics, and therapy of pediatric patients with myocarditis in…
- Trial name
- MYKKE (NCT02590341)
- Where
- 13 sites in Germany
- Volunteers
- 1,500 people
- Sponsor
- German Heart Institute
Pediatric Heart Failure
Home Monitoring in Pediatric Heart Failure
Heart failure is a complex clinical syndrome, representing the final evolution of many cardiac diseases that may differ for etiology and pathophysiology.
- Trial name
- HOPE-HF (NCT05017077)
- Testing
- DynaVision System
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Bambino Gesù Hospital and Research Institute
Dilated Cardiomyopathy
A Trial of Autologous Bone Marrow Derived Stem Cells in Paediatric Heart Failure
The bone marrow mononuclear cell fraction has been used as therapy after myocardial infarction and in dilated cardiomyopathy in adults.
- Trial name
- NCT02479776
- Testing
- stem cell injection
- Volunteers
- 10 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Acute Heart Failure
Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units
To describe pharmacokinetics of levosimendan in neonates and children supported or not with extracorporeal circulation devices (ECMO, CRRT)
- Trial name
- PALMAréa (NCT03681379)
- Where
- France
- Volunteers
- 27 people
- Sponsor
- Nantes University Hospital
Cardiotoxicity, Pediatric Cancer
Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure
Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity.
- Conditions
- Cardiotoxicity, Pediatric Cancer, Heart Failure
- Trial name
- CATCH-HF (NCT04262830)
- Testing
- Cardiac magnetic resonance imaging (MRI), Accelerometer physical activity monitoring
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Hari Narayan
Heart Failure
Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population
There is a need for developing reliable and convenient technologies for telemonitoring of physiological signals such as respiration, cardiac function, and activity level in children and especially for those with heart disease.
- Trial name
- NCT04305340
- Testing
- Myant SKIIN Device
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Aamir Jeewa
Children, Chronic Renal Failure
Effect of Strict Blood Pressure Control and ACE-Inhibition on Progression of Chronic Renal Failure in Pediatric Patients
In children with chronic kidney disease, progression to end-stage renal failure is associated with high patient morbidity and poor quality of life.
- Conditions
- Children, Chronic Renal Failure, Hypertension, Acquired Kidney Disease
- Trial name
- ESCAPE (NCT00221845)
- Testing
- ACE Inhibition, Intensified Blood Pressure Control, Add-on Angiotensin Receptor Blockade
- Where
- 33 sites in Czechia, France and 10 more
- Volunteers
- 400 people
- Sponsor
- Heidelberg University