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Protocol Number21466
NCT Number(ClinicalTrials.gov Identfier)NCT07188805
Active

2025-11-14 - 2030-06-28

Phase III

Recruiting6

ICD-10I50.20

Unspecified systolic (congestive) heart failure

ICD-10I50.21

Acute systolic (congestive) heart failure

ICD-10I50.22

Chronic systolic (congestive) heart failure

ICD-10I50.23

Acute on chronic systolic (congestive) heart failure

ICD-10I50.30

Unspecified diastolic (congestive) heart failure

ICD-10I50.31

Acute diastolic (congestive) heart failure

ICD-10I50.32

Chronic diastolic (congestive) heart failure

ICD-10I50.33

Acute on chronic diastolic (congestive) heart failure

ICD-10I50.40

Unspecified combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.41

Acute combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.42

Chronic combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.43

Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.9

Heart failure, unspecified

ICD-9428.0

Congestive heart failure

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)

  • Trial Applicant

    BAYER TAIWAN COMPANY LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 林宜君 Division of Pediatrics
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shuenn Nan Chiu Division of Pediatrics
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 翁根本 Division of Pediatrics
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 莊傑貿 Division of Pediatrics
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳宇萱 Division of Pediatrics
MacKay Children's Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jieh-Neng Wang
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Left Ventricular Systolic Dysfunction

Objectives

This trial, as described in this protocol, aims to investigate the efficacy, safety, and pharmacokinetic/proliferative capacity (PK/PD) of finerenone in children with heart failure, further strengthening the positive outcome base obtained in the adult HF population, and helping to address the significant unmet need for effective treatment in children with HF. 1. Primary Trial Objective • To evaluate the effect of adding finerenone to standard treatment (SoC) compared to placebo in reducing NT-proBNP levels. 2. Key Secondary Trial Objectives • To evaluate the safety profile of adding finerenone to standard treatment (SoC) compared to placebo in children with LVSD. • To confirm the efficacy of adding finerenone to standard treatment (SoC) compared to placebo. • To confirm the dosage and systemic exposure of finerenone in children with LVSD.

Test Drug

錠劑
錠劑
錠劑
懸浮液用顆粒劑
錠劑
懸液用顆粒劑

Active Ingredient

Finerenone micronized
BAY 94-8862
placebo
Placebo

Dosage Form

110
110
15C
110
151

Dosage

10mg/tablet
20mg/tablet
40mg/tablet
3.4%(W/W)
N/A

Endpoints

The change in NT-proBNP from baseline to month 3 in subjects receiving the investigational drug compared to the placebo group.

Inclution 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

Exclusion Criteria:

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 Estimated Number of Participants

  • Taiwan

    9 participants

  • Global

    222 participants

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