BridgeMD
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
EU CTIS ID: 2024-519829-38-00
What this study is testing
To evaluate the effect of finerenone in addition to standard of care (SoC) on reducing NT-proBNP levels compared to placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed.
- LV 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.
You likely can't join if
- Serum potassium: • >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 screening or randomization visit
- 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.
See the full eligibility criteria
- Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed.
- LV 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.
- Serum potassium: • >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 screening or randomization visit
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Brazil
- Canada
- United States
- United Kingdom
- Taiwan
- Argentina
- Korea, Republic of
- Mexico
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Brazil; Canada; United States; United Kingdom; Taiwan and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.