Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT07188805
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576501', 'term': 'finerenone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 111}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-09-08', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in NT-proBNP levels', 'timeFrame': 'From baseline to Day 90±3'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-emergent adverse events (TEAEs)', 'timeFrame': 'From the start of study intervention to last study intervention (up to 93 days) + 3 days', 'description': 'TEAEs will be mapped to Medical Dictionary for Regulatory Activities (MedDRA) terms'}, {'measure': 'Change in serum potassium levels', 'timeFrame': 'From baseline to Day 90±3'}, {'measure': 'Change in estimated glomerular filtration rate (eGFR)', 'timeFrame': 'From baseline to Day 90±3'}, {'measure': 'Change in systolic blood pressure (SBP)', 'timeFrame': 'From baseline to Day 90±3'}, {'measure': 'Change in left ventricular systolic function', 'timeFrame': 'From baseline to Day 90±3', 'description': 'Change measured by echocardiogram (%) from baseline to Day 90±3'}, {'measure': 'Total number of cardiovascular outcome events, including cardiovascular death, heart transplantation, and clinical worsening of heart failure', 'timeFrame': 'From baseline to Day 90±3'}, {'measure': 'Maximum observed finerenone concentration in plasma after multiple doses (Cmax, md)', 'timeFrame': 'Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 90±3'}, {'measure': 'Area under the curve for finerenone concentration in plasma after multiple doses (AUCτ,md)', 'timeFrame': 'Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 90±3'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Left Ventricular Systolic Dysfunction', 'Heart Failure (Pediatric)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/study/21466', 'label': "Click here to find further information and, after study completion, the study results according to Bayer's transparency standards."}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nAt 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:\n\n* have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured\n* have their heart examined by electrocardiogram (ECG) and echocardiogram\n* have blood samples taken\n* have physical examinations\n* answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answers\n\nAn 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.\n\nAfter 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be 6 months to \\<18 years old at the time when the informed consent/assent is signed.\n* Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography.\n* Elevated NT-pro BNP levels\n\n * \\>500 ng/l for children ≥ 6 months to \\< 2 years of age\n * \\>300 ng/l, for children ≥ 2 years to \\<18 years\n* 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.\n* 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.\n* Study participants must have a body weight ≥ 4.0 kg at Visit 1.\n\nExclusion Criteria:\n\n* Serum potassium:\n\n * \\> 5.0 mmol/L for children ≥ 2 years of age at either screening or randomization visit\n * \\> 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)\n* Severe renal dysfunction with eGFR \\< 30 ml/min/1.73m² at screening or randomization visit.\n* Systolic blood pressure (SBP) \\< 5th percentile for age, sex and height at screening or randomization.\n* Sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to randomization.\n* Treatment with a mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone) within 30 days of randomization.\n* Requirement of any intravenous (IV) vasoactive agents, mechanical ventilation, mechanical circulatory support within 30 days prior to randomization.\n* 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.'}, 'identificationModule': {'nctId': 'NCT07188805', 'acronym': 'FIORE', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '21466'}, 'secondaryIdInfos': [{'id': '2024-519829-38-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Finerenone (Kerendia, BAY94-8862)', 'description': 'Participants will receive finerenone treatment.', 'interventionNames': ['Drug: Finerenone (Kerendia, BAY94-8862)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo to finerenone.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Finerenone (Kerendia, BAY94-8862)', 'type': 'DRUG', 'description': 'Finerenone in different doses, treatment duration will be 90±3 days', 'armGroupLabels': ['Finerenone (Kerendia, BAY94-8862)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to finerenone, treatment duration will be 90±3 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Children's Hospital Colorado - Anschutz Medical Campus - Cardiology", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Nemours Children's Hospital -Delaware", 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'UF Health Shands Hospital - Pediatric Cardiology', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Joe Dimaggio Children's Hospital - Cardiology", 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Emory University Hospital - Children's Healthcare of Atlanta Cardiology - Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Riley Hospital For Children - Cardiology', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Boston Children's Hospital - Main Campus - Cardiology", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "C.S. 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Pendik EAH Kardiyoloji', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': 'TBC', 'city': 'Istanbul', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35210', 'city': 'Izmir', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Dr. Behcet Uz Cocuk Hastaliklari Hast', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'Leicestershire', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': "University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility", 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'L122AP', 'city': 'Liverpool', 'state': 'Merseyside', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': "Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'BT12 6BE', 'city': 'Belfast', 'state': 'Northern Ireland', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'state': 'Scotland', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': "Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart Unit", 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'state': 'West Yorkshire', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': "Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research Facility", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'BS2 8AE', 'city': 'Bristol', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}], 'centralContacts': [{'name': 'Bayer Clinical Trials Contact', 'role': 'CONTACT', 'email': 'clinical-trials-contact@bayer.com', 'phone': '(+)1-888-84 22937'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.\n\nAs such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nResearchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}