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Compares treatment options for Left Ventricular Systolic Dysfunction
Official title 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
ClinicalTrials.gov ID: NCT07188805
What this study is testing
What is Finerenone (Kerendia, BAY94-8862)?
Finerenone (Kerendia, BAY94-8862) is an investigational medicine, being studied as a potential treatment for left ventricular systolic dysfunction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
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.
- 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
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 \ 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.
See the full eligibility 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...
- 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 \ 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
- Aurora, Colorado, United States
- Wilmington, Delaware, United States
- Gainesville, Florida, United States
- Hollywood, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- New York, New York, United States
- The Bronx, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- North Charleston, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
+ 97 more site(s).
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, 6 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Wilmington, Delaware, United States; Gainesville, Florida, United States; Hollywood, Florida, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States and 111 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 ClinicalTrials.gov; the study team decides eligibility.