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RecruitingPhase 3

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Investigate the Efficacy, Safety, and PK/ PD of Finerenone, in Addition to Standard-of-care, in Pediatric Patients, 6 Months to < 18 Years of Age With Heart Failure (HF) and Left Ventricular Systolic Dysfunction (LVSD)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Months to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 90 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "If participants qualify for the treatment phase, they will undergo treatment for about 90 days."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests finerenone in children ages 6 months to under 18 years with heart failure whose main heart pumping chamber does not squeeze well. It compares finerenone with a placebo, which has no medicine, while children keep taking their usual heart failure treatments for 3 months. Researchers will check how well it works, its safety, and how it moves through the body.

Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure is a serious condition where the heart is unable to pump enough blood to meet the body's needs. This can lead to symptoms like shortness of breath, fatigue, and poor growth in children. The study treatment, finerenone (also called BAY94-8862), works by blocking a protein involved in inflammation, scarring, and thickening of the heart and blood vessels. This may help the heart to pump blood more effectively. This is the first study to explore its use specifically for children with heart failure and LVSD. The main purpose of this study is to learn if finerenone works to help the heart compared to placebo in children with heart failure and LVSD. For this, the researchers will collect and analyze data on the levels of a protein called NT-proBNP in the blood, which indicates heart stress, and monitor the safety of the treatment. The study will include children with heart failure and LVSD aged from 6 months to less than 18 years. The study participants will be randomly assigned to one of two treatment groups. Based on their group, they will receive either finerenone or a placebo for a duration of 3 months. A placebo looks like a treatment but does not have any medicine in it. Throughout the study, all participants will continue to receive their standard heart failure treatments. At the start of this study, the doctors will check each participant's medical history and current medications. If participants qualify for the treatment phase, they will undergo treatment for about 90 days. During this time, they will visit the study site at least 3 times. During these visits, the participants will: * have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured * have their heart examined by electrocardiogram (ECG) and echocardiogram * have blood samples taken * have physical examinations * answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answers An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. After the initial three-month study, eligible participants will have the option to join a nine-month open-label extension study where all will receive finerenone. Participants who choose not to enroll in the extension will have a follow-up visit 30 days after their last treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 6 months to under 18 years when study consent is signed.
  • Have a weak left heart pumping chamber that pumps out 50% or less of its blood with each beat, measured by a heart ultrasound.
  • Have a high level of NT-proBNP, a blood marker of heart stress: above 500 ng/L for children under 2, or above 300 ng/L for children ages 2 and older.
  • Have heart failure from one of the listed causes. These include certain birth defects, inherited or other heart muscle diseases, muscle or energy-use disorders, past heart inflammation, or damage from illness, treatment, poor nutrition, or low blood flow.
  • If heart failure followed heart muscle inflammation, the sudden illness must have been diagnosed at least 3 months before treatment group assignment.
  • Be on usual heart failure treatment, with a stable treatment plan for 30 days before treatment group assignment.
  • Weigh at least 4 kg (about 8.8 pounds) at the first visit.

Who can't join

  • Have high blood potassium at screening or treatment group assignment: above 5.0 mmol/L for ages 2 and older, or above 5.3 mmol/L for children under 2. For children under 2 with a kidney filtering score below 60, the limit is 5.0 mmol/L.
  • Have severe kidney problems, with an eGFR kidney filtering score below 30 mL/min/1.73 m² at treatment group assignment.
  • Have a top blood pressure number below the 5th percentile for age, sex, and height at screening or treatment group assignment. This means it is lower than that of about 95 out of 100 similar children.
  • Have lasting or symptom-causing abnormal heart rhythms not controlled by medicine or a device within the 30 days before treatment group assignment.
  • Have taken a medicine called a mineralocorticoid receptor blocker, such as spironolactone or eplerenone, within 30 days of treatment group assignment.
  • Have needed IV medicine to support blood pressure or blood flow, a breathing machine, or a device to help pump blood within the 30 days before treatment group assignment.
  • Have had surgery or another procedure for a heart birth defect within the past 3 months, or expect to have heart surgery during the 3 months after treatment group assignment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participants must be 6 months to \<18 years old at the time when the informed consent/assent is signed. * Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography. * Elevated NT-pro BNP levels * \>500 ng/l for children ≥ 6 months to \< 2 years of age * \>300 ng/l, for children ≥ 2 years to \<18 years * Heart failure etiologies including congenital heart defects (CHD) with biventricular physiology and systemic LV; idiopathic cardiomyopathy (CM); familial/inherited and/or genetic CM; history of myocarditis (diagnosis of an acute episode was at least 3 months prior to randomization); neuromuscular disorder (eg, duchenne muscular dystrophy); inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (eg, Kawasaki disease and postoperative heart failure \[HF\]); LV noncompaction. * Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion and being on a stable regimen for 30 days prior to randomization. * Study participants must have a body weight ≥ 4.0 kg at Visit 1. Exclusion Criteria: * Serum/plasma potassium (based on local laboratory results): * \> 5.0 mmol/L for children ≥ 2 years of age at either screening or randomization visit * \> 5.3 mmol/L for children ≥ 6 months to \< 2 years of age at either screening or randomization visit (if estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73m², threshold of \> 5.0 mmol/L will be used) * Severe renal dysfunction with eGFR \< 30 mL/min/1.73m² at randomization visit based on local laboratory results. * Systolic blood pressure (SBP) \< 5th percentile for age, sex and height at screening or randomization. * Sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to randomization. * Treatment with a mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone) within 30 days of randomization. * Requirement of any intravenous (IV) vasoactive agents, mechanical ventilation, mechanical circulatory support within 30 days prior to randomization. * Recent surgical procedure or other intervention to correct or palliate CHD within 3 months prior to randomization or anticipated to undergo cardiac surgery during the 3 months after randomization.

Study sites (22)

CO

  • Children's Hospital Colorado - Anschutz Medical Campus - Cardiology · Aurora, CO 80045More trials in Aurora

DE

FL

GA

  • Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta · Atlanta, GA 30329More trials in Atlanta

IN

MA

MI

MO

NY

OH

PA

SC

TX

UT