Clinical trials: Pediatric Heart Failure
Heart Failure
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (PANORAMA-HF) core study Part 2…
- Trial name
- NCT03785405
- Testing
- sacubitril/valsartan
- Where
- 79 sites in United States, Argentina and 25 more
- Volunteers
- 216 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure, Cardiogenic Shock
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to: 1.
- Conditions
- Heart Failure, Cardiogenic Shock, Congenital Heart Disease, Cardiomyopathies
- Trial name
- TROLLEY (NCT06080074)
- Testing
- Cardiohelp device (VA-ECMO), Heparin, Bivalirudin
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Stanford University
Congenital Cardiac Defect, Acute Renal Injury
Investigation of the Relationship Between Blood Transfusion Volume and Development of Renal Failure in Pediatric Patients Undergoing Cardiovascular Surgery
Blood transfusion strategies in cardiac surgery are a research topic that has been studied more for adults. There is not enough data on this subject for children in studies.
- Conditions
- Congenital Cardiac Defect, Acute Renal Injury, Blood Transfusion Complication
- Trial name
- NCT06889272
- Testing
- blood transfusion
- Where
- Turkey (Türkiye)
- Volunteers
- 205 people
- Sponsor
- Hacettepe University
Pediatric Heart Transplantation, Immunosuppression
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years.
- Conditions
- Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy
- Trial name
- TEAMMATE (NCT03386539)
- Testing
- Everolimus, Tacrolimus, Mycophenolate Mofetil
- Where
- 25 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Children's Hospital
Acute Heart Failure, Dilated Cardiomyopathy
Early Administration of Ivabradine in Children With Heart Failure
This is a monocentric, prospective, single arm, not for profit study. It is designed to study the early use of ivabradine in patients with dilated cardiomyopathy and Ejection Fraction (EF) < 45%.
- Trial name
- EASI-Child (NCT04405804)
- Testing
- Ivabradine 5Mg Tab
- Where
- Italy
- Volunteers
- 9 people
- Sponsor
- Bambino Gesù Hospital and Research Institute
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction
Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD).
- Trial name
- FIORE (NCT07188805)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- 133 sites in United States, Argentina and 21 more
- Volunteers
- 111 people
- Sponsor
- Bayer
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
Heart Failure, Children
National Multicenter Registry for Pediatric End-Stage Heart Failure in China
To establish a multicenter pediatric end-stage heart failure (ESHF) specialized disease data platform and promote its adoption across major children's medical centers nationwide.
- Trial name
- NCT06927440
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Pediatric Heart Failure
Pumps for Kids, Infants, and Neonates
PumpKIN is a multicenter, prospective, single-arm feasibility study; Evaluating the investigational Jarvik 2015 VAD in pediatric patients with heart failure.
- Trial name
- PumpKIN (NCT02954497)
- Testing
- Surgical placement of the Jarvik 2015 VAD, Surgical Placement of Jarvik 2015 VAD
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- Carelon Research
Acute Heart Failure
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)
- Trial name
- RELAX-PEDS-PK (NCT02151383)
- Testing
- Serelaxin
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Congenital Disease
Kids Intestinal Dysfunction in Congenital Heart Disease: the Kind Heart Study
Approximately 40,000 infants are born each year in the United States with congenital heart defects (CHD), and heart defects are the leading cause of birth defect-related deaths in the United States.
- Trial name
- NCT02824705
- Testing
- Congenital Heart Disease Surgery
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- University of Arizona
Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure
Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients
The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit.
- Conditions
- Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure, Persistent Pulmonary Hypertension of Newborn, Congenital Heart Defects
- Trial name
- NCT00981591
- Testing
- Iloprost
- Sponsor
- Seattle Children's Hospital
Critical Illness, Pediatric Critical Illness
Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children
This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit…
- Conditions
- Critical Illness, Pediatric Critical Illness, Respiratory Failure, Traumatic Brain Injury
- Trial name
- NCT07613918
- Testing
- Transcranial Doppler
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- University of Wisconsin, Madison
Cardiac Failure
Near Infrared Spectroscopy (NIRS) for Heart Failure Assessment.
It is routine practice for a cardiologist to perform a battery of tests to assess the degree of heart failure. The purpose of this study is to establish a non-invasive method to reliably predict cardiac output state in real-time…
- Trial name
- NCT01577810
- Testing
- Near Infrared Spectroscopy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Phoenix Children's Hospital
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD).
- Trial name
- FIORELLO (NCT07192952)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- 132 sites in United States, Argentina and 21 more
- Volunteers
- 117 people
- Sponsor
- Bayer
HCM, Noonan Syndrome and Other Rasopathy
Clinical Trial of a MEK Inhibitor for RASopathy-Associated Severe Infantile Hypertrophic Cardiomyopathy: Baby MERIT
This project seeks to perform a Phase 3 clinical trial to test whether an FDA-approved cancer drug called trametinib is effective in treating young infants with genetic conditions called RASopathies and a severe, life-threatening…
- Conditions
- HCM, Noonan Syndrome and Other Rasopathy, Heart Failure (Pediatric)
- Trial name
- Baby MERIT (NCT07817186)
- Testing
- Trametinib
- Volunteers
- 25 people
- Sponsor
- Carelon Research
Heart Failure With Reduced Ejection Fraction, Pediatric HD, Stage IV
Pumps for Kids, Infants and Neonates (PumpKIN): The Jarvik 2015 Pivotal Trial
This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to…
- Conditions
- Heart Failure With Reduced Ejection Fraction, Pediatric HD, Stage IV, LVAD
- Trial name
- PumpKIN (NCT06348043)
- Testing
- Jarvik 2015 LVAD
- Volunteers
- 22 people
- Sponsor
- Stanford University
Heart Failure
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric patients who have experienced heart failure during surgery and cannot be removed from cardiac…
- Trial name
- NCT01171950
- Testing
- CentriMag Ventricular Assist System
- Sponsor
- Abbott Medical Devices
Heart Decompensation
Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure
Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.
- Trial name
- NCT02973620
- Testing
- Levosimendan
- Sponsor
- Tenax Therapeutics, Inc.
Congenital Heart Disease, Advanced Heart Failure
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
TORCH-LATAM-003 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for children and adults with congenital heart disease and advanced cardiac and/or respiratory failure who may require heart…
- Conditions
- Congenital Heart Disease, Advanced Heart Failure, Respiratory Failure, Heart Transplantation
- Trial name
- TORCH-003 (NCT07837024)
- Testing
- TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.