Clinical trial • Phase III • Cardiology
N/A for Heart failure with reduced ejection fraction (HFrEF)
Phase III trial of N/A for Heart failure with reduced ejection fraction (HFrEF).
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Heart failure with reduced ejection fraction (HFrEF)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 05-03-2025
- First CTIS Authorization Date
- 20-06-2025
Trial design
Randomised, placebo for bay 94-8862 (placebo arm); active comparator: finerenone (bay 94-8862) oral film-coated tablet (active substance: finerenone). dose information in product records: max daily doses listed include 10 mg, 20 mg, 40 mg (dose units mg); specific dosing schedule not specified in the provided data.-controlled Phase III trial in Czechia, Hungary, Poland and others.
- Randomised
- Yes
- Comparator
- Placebo for BAY 94-8862 (placebo arm); active comparator: Finerenone (BAY 94-8862) oral film-coated tablet (active substance: finerenone). Dose information in product records: max daily doses listed include 10 mg, 20 mg, 40 mg (dose units mg); specific dosing schedule not specified in the provided data.
- Target Sample Size
- 1860
Eligibility
Recruits 1860 Vulnerable population selected (isVulnerablePopulationSelected=true). Participants must provide written informed consent. No specific assent procedures or additional consent handling details are provided in the supplied data..
- Pregnancy Exclusion
- 5. Persons of childbearing potential can only be included in the study if a pregnancy test is negative at screening and if they agree to use highly effective contraception which is consistent with local regulations regarding the methods for contraception for the duration of the study.
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true). Participants must provide written informed consent. No specific assent procedures or additional consent handling details are provided in the supplied data.
Inclusion criteria
- {"criterion_text":"- 2. Age ≥18 years or legal age of majority if >18 years in the participant’s country of residence."}
- {"criterion_text":"- 3. Symptomatic HFrEF (must meet all criteria) • NYHA class II – IV symptoms at screening and randomization • Most recent ejection fraction <40% by imaging (e.g., echocardiogram, cardiac MRI, nuclear scan) within 12 months prior to screening • Qualifying natriuretic peptide level: Most recent local laboratory value within 14 days of randomization for patients with recent HHF (discharged within prior 10 days) or within 30 days for patients without recent HHF must meet the qualifying threshold below. If no value is available in the medical record, a local lab value must be obtained. Note: for participants treated with an angiotensin receptor/neprilysin inhibitor (ARNI) in the previous 4 weeks prior to natriuretic peptide measurement, only NTproBNP values should be used."}
- {"criterion_text":"- 4. Not on sMRA (i.e., spironolactone, eplerenone or canrenone/potassium canrenoate) due to documented history of being either intolerant, contraindicated (e.g., due to eGFR <30 mL/min/1.73m2) or considered ineligible for treatment with sMRA . • Intolerance is defined as at least one episode of hyperkalemia, or an episode of worsening kidney function, or an episode of sexual side effects or hypotension, each leading to drug interruption or discontinuation. • Ineligibility is in the opinion of the treating physician and/or investigator."}
- {"criterion_text":"- 5. Persons of childbearing potential can only be included in the study if a pregnancy test is negative at screening and if they agree to use highly effective contraception which is consistent with local regulations regarding the methods for contraception for the duration of the study."}
- {"criterion_text":"- 1. Provide written informed consent."}
Exclusion criteria
- {"criterion_text":"- 1. Treatment with any MRA (e.g., spironolactone, eplerenone, finerenone, esaxerenone, apararenone) within 30 days prior to randomization; treatment with any MRA should not be interrupted for the purpose of enrollment into the study."}
- {"criterion_text":"- 10. Concomitant treatment with: a) systemic potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g., itraconazole, ritonavir, indinavir, cobicistat, clarithromycin), or moderate CYP3A4 inducers (e.g., efavirenz, phenobarbital), or potent CYP3A4 inducers (e.g., carbamazepine, phenytoin, St John’s Wort) that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period (note: a list of prohibited concomitant medications and excluded and allowed CYP3A4 inhibitors and inducers is provided in Appendix D); b) or a renin inhibitor or more than one of an angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin-receptor-neprilysin-inhibitor (ARNI); c) or a potassium-sparing diuretic that cannot be stopped prior to randomization and for the duration of the treatment period."}
- {"criterion_text":"- 11. Known hypersensitivity to the IP (active substance or excipients)"}
- {"criterion_text":"- 12. Any other condition or therapy (e.g., breastfeeding, cardiogenic shock, clinically overt severe hepatic insufficiency [Child Pugh C], Addison’s disease, malignancy or other severe condition as per investigator’s judgment such as disease with <1 year life expectancy) which would make the participant unsuitable for this study and not allow participation for the full planned study period"}
- {"criterion_text":"- 13. Concurrent or previous participation in another interventional clinical study using an investigational agent (e.g., not approved for any indication) within 30 days or 5 half-lives of the study drug, whichever is longer, prior to randomization."}
- {"criterion_text":"- 2. Documented prior history of severe hyperkalemia (potassium ≥6.0 mmol/L and/or resulting in hospitalization or Emergency Department visit) in the setting of MRA use"}
- {"criterion_text":"- 3. eGFR <25 mL/min/1.73m² and / or potassium >5.0 mmol/L at screening (most recent value within 14 days of randomization if acutely hospitalized or discharged within the last 10 days; within 30 days of randomization if no recent hospitalization). Note: eGFR and potassium should be repeated prior to randomization if renin-angiotensin system antagonist started or dose increased since most recent prior measurement"}
- {"criterion_text":"- 4. Acute MI, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days prior to randomization or planned (note: pacemakers or implantable cardioverter defibrillators without resynchronization function are allowed)"}
- {"criterion_text":"- 5. Prior heart transplant or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement) or currently using or plan for mechanical circulatory support, e.g., left ventricular assist device, intra-aortic balloon pump, or participants on mechanical ventilation or participants with planned outpatient inotropic support"}
- {"criterion_text":"- 6. Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)"}
- {"criterion_text":"- 7. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker"}
- {"criterion_text":"- 8. Cardiomyopathy due to known acute inflammatory heart disease (e.g., acute myocarditis within 90 days prior to randomization), infiltrative diseases (e.g., amyloidosis), accumulation diseases (e.g., haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g., stress cardiomyopathy), known hypertrophic obstructive cardiomyopathy, complex (according to investigator`s judgement) congenital heart disease, or known pericardial constriction"}
- {"criterion_text":"- 9. Probable alternative cause of participant’s HF symptoms that, in the opinion of the investigator, primarily accounts for patient’s symptoms; specifically, participants with severe pulmonary disease requiring home oxygen or chronic oral steroid therapy, primary pulmonary arterial hypertension at screening"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the time to first occurrence of cardiovascular death or a heart failure event.","definition_or_measurement_approach":"Time-to-event analysis: time from randomization to first occurrence of cardiovascular death or a heart failure event (as stated)."}
Secondary endpoints
- {"endpoint_text":"- Secondary endpoints include treatment group differences in: Timing and occurrence of total (first and recurrent) events of cardiovascular (CV) death and heart failure (HF) events. Timing and occurrence of total (first and recurrent) HF events. Change in Kansas City Cardiomyopathy Questionnaire – Total Symptom Score (KCCQ-TSS) from baseline to Month 6. Time to CV death. Time to all-cause death.","definition_or_measurement_approach":"Endpoints include timing and occurrence (time-to-event and event counts for first and recurrent events), change from baseline in KCCQ-TSS at Month 6, and time-to-event for CV death and all-cause death as specified."}
Recruitment
- Planned Sample Size
- 1860
- Recruitment Window Months
- 36
- Consent Approach
- Written informed consent required from participants. Participants must be aged ≥18 (or legal age of majority in their country). Subject information and informed consent form documents are available in multiple country/language versions (examples in the dossier: English, Polish, Greek, Italian, Hungarian, Czech, Croatian, Spanish and country-specific ICFs). No additional assent procedures are provided in the available data.
Geography
- Total Number Of Sites
- 70
- Total Number Of Participants
- 740
Czechia
- Earliest CTIS Part Ii Submission Date
- 10-04-2025
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 307
- Number Of Sites
- 8
- Number Of Participants
- 100
Sites
- Site Name
- Dr.Kuchar Kardiologie s.r.o
- Department Name
- Cardiology outpatient clinic
- Principal Investigator Name
- Jiří Kuchař
- Principal Investigator Email
- jirkakuchar@centrum.cz
- Contact Person Name
- Jiří Kuchař
- Contact Person Email
- jirkakuchar@centrum.cz
- Site Name
- Kardiologicka ambulance Brno s.r.o.
- Department Name
- Cardiology outpatient clinic
- Principal Investigator Name
- Jiri Parenica
- Principal Investigator Email
- jiri.parenica@atlas.cz
- Contact Person Name
- Jiri Parenica
- Contact Person Email
- jiri.parenica@atlas.cz
- Site Name
- Nemocnice Tabor a.s.
- Department Name
- Cardiology
- Principal Investigator Name
- Rostislav Král
- Principal Investigator Email
- rostislav.kral@nemta.cz
- Contact Person Name
- Rostislav Král
- Contact Person Email
- rostislav.kral@nemta.cz
- Site Name
- Nemocnice AGEL Trinec-Podlesi a.s.
- Department Name
- Cardiology outpatient clinic
- Principal Investigator Name
- Alexandra Vodzinská
- Principal Investigator Email
- avodzinska@volny.cz
- Contact Person Name
- Alexandra Vodzinská
- Contact Person Email
- avodzinska@volny.cz
- Site Name
- Institute For Clinical And Experimental Medicine
- Department Name
- Acute cardiology department
- Principal Investigator Name
- Marek Šramko
- Principal Investigator Email
- marek.sramko@ikem.cz
- Contact Person Name
- Marek Šramko
- Contact Person Email
- marek.sramko@ikem.cz
- Site Name
- KardioBusak s.r.o.
- Department Name
- Cardiology outpatient clinic
- Principal Investigator Name
- Ladislav Bušák
- Principal Investigator Email
- L.Busak@seznam.cz
- Contact Person Name
- Ladislav Bušák
- Contact Person Email
- L.Busak@seznam.cz
- Site Name
- Kardio Chlumec s.r.o.
- Department Name
- Cardiology
- Principal Investigator Name
- Martin Wiendl
- Principal Investigator Email
- wiendlmartin@seznam.cz
- Contact Person Name
- Martin Wiendl
- Contact Person Email
- wiendlmartin@seznam.cz
- Site Name
- KardioBusak s.r.o.
- Department Name
- Cardiology outpatient clinic
- Principal Investigator Name
- Ladislav Bušák
- Principal Investigator Email
- L.Busak@seznam.cz
- Contact Person Name
- Ladislav Bušák
- Contact Person Email
- L.Busak@seznam.cz
Hungary
- Earliest CTIS Part Ii Submission Date
- 30-04-2025
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 287
- Number Of Sites
- 8
- Number Of Participants
- 130
Sites
- Site Name
- Semmelweis University
- Department Name
- Cardiology
- Principal Investigator Name
- Béla Merkely
- Principal Investigator Email
- merkely.study@gmail.com
- Contact Person Name
- Béla Merkely
- Contact Person Email
- merkely.study@gmail.com
- Site Name
- Central Hospital Of Northern Pest Military Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Gabor Duray
- Principal Investigator Email
- gduray@gmail.com
- Contact Person Name
- Gabor Duray
- Contact Person Email
- gduray@gmail.com
- Site Name
- Vasarhelyi Sarkanyfu Kft.
- Department Name
- Cardiology
- Principal Investigator Name
- Attila Palinkas
- Principal Investigator Email
- palinkasa@hotmail.com
- Contact Person Name
- Attila Palinkas
- Contact Person Email
- palinkasa@hotmail.com
- Site Name
- Medifarma-98 Kft.
- Principal Investigator Name
- Zsolt Zilahi
- Principal Investigator Email
- drzilahi@gmail.com
- Contact Person Name
- Zsolt Zilahi
- Contact Person Email
- drzilahi@gmail.com
- Site Name
- Pharma 4 Trial Kft.
- Department Name
- Cardiology
- Principal Investigator Name
- Attila Mohacsi
- Principal Investigator Email
- attila.mohacsi@pharma4trial.net
- Contact Person Name
- Attila Mohacsi
- Contact Person Email
- attila.mohacsi@pharma4trial.net
- Site Name
- University Of Pecs
- Department Name
- Cardiology
- Principal Investigator Name
- Zsolt Marton
- Principal Investigator Email
- marton.zsolt@pte.hu
- Contact Person Name
- Zsolt Marton
- Contact Person Email
- marton.zsolt@pte.hu
- Site Name
- Budapesti Jahn Ferenc Del Pesti Korhaz Es Rendelointezet
- Department Name
- Cardiology
- Principal Investigator Name
- Jozsef Lippai
- Principal Investigator Email
- drlippai@gmail.com
- Contact Person Name
- Jozsef Lippai
- Contact Person Email
- drlippai@gmail.com
- Site Name
- University Of Szeged
- Department Name
- Cardiology
- Principal Investigator Name
- Andras Farkas
- Principal Investigator Email
- farkas.andras@med.u-szeged.hu
- Contact Person Name
- Andras Farkas
- Contact Person Email
- farkas.andras@med.u-szeged.hu
Poland
- Earliest CTIS Part Ii Submission Date
- 26-05-2025
- Latest Decision Or Authorization Date
- 15-10-2025
- Processing Time Days
- 142
- Number Of Sites
- 11
- Number Of Participants
- 120
Sites
- Site Name
- Clinical Best Solutions Sp. z o.o. S.K.
- Principal Investigator Name
- Piotr Denysiuk
- Principal Investigator Email
- piotr.denysiuk@gmail.com
- Contact Person Name
- Piotr Denysiuk
- Contact Person Email
- piotr.denysiuk@gmail.com
- Site Name
- Medicome Sp. z o.o.
- Principal Investigator Name
- Iwona Kobielusz-Gembala
- Principal Investigator Email
- iwonagembala@wp.pl
- Contact Person Name
- Iwona Kobielusz-Gembala
- Contact Person Email
- iwonagembala@wp.pl
- Site Name
- Provita Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Ewa Kalecińska-Krystkiewicz
- Principal Investigator Email
- e.krystkiewicz@gmail.com
- Contact Person Name
- Ewa Kalecińska-Krystkiewicz
- Contact Person Email
- e.krystkiewicz@gmail.com
- Site Name
- Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
- Department Name
- Cardiology
- Principal Investigator Name
- Łukasz Wiśniowski
- Principal Investigator Email
- dr.lukasz.wisniowski@gmail.com
- Contact Person Name
- Łukasz Wiśniowski
- Contact Person Email
- dr.lukasz.wisniowski@gmail.com
- Site Name
- Centrum Medyczne NessMedica
- Department Name
- Cardiology
- Principal Investigator Name
- Jadwiga Nessler
- Principal Investigator Email
- jnessler@interia.pl
- Contact Person Name
- Jadwiga Nessler
- Contact Person Email
- jnessler@interia.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Cardiology
- Principal Investigator Name
- Ewa Straburzyńska-Migaj
- Principal Investigator Email
- ewa.straburzynska-migaj@skpp.edu.pl
- Contact Person Name
- Ewa Straburzyńska-Migaj
- Contact Person Email
- ewa.straburzynska-migaj@skpp.edu.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Cardiology
- Principal Investigator Name
- Anna Fojt
- Principal Investigator Email
- anna.fojt@wum.edu.pl
- Contact Person Name
- Anna Fojt
- Contact Person Email
- anna.fojt@wum.edu.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ
- Department Name
- Cardiology
- Principal Investigator Name
- Malgorzata Lelonek
- Principal Investigator Email
- malgorzata.lelonek@umed.lodz.pl
- Contact Person Name
- Malgorzata Lelonek
- Contact Person Email
- malgorzata.lelonek@umed.lodz.pl
- Site Name
- American Heart Of Poland S.A.
- Department Name
- Cardiology
- Principal Investigator Name
- Adam Janas
- Principal Investigator Email
- adamjanas@icloud.com
- Contact Person Name
- Adam Janas
- Contact Person Email
- adamjanas@icloud.com
- Site Name
- Umed Clinical Trials Sp. z o.o.
- Department Name
- Cardiology
- Principal Investigator Name
- Jaroslaw Drozdz
- Principal Investigator Email
- jaroslaw.drozdz@umed.lodz.pl
- Contact Person Name
- Jaroslaw Drozdz
- Contact Person Email
- jaroslaw.drozdz@umed.lodz.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Cardiology
- Principal Investigator Name
- Anna Tomaszuk-Kazberuk
- Principal Investigator Email
- a.tomaszuk@poczta.fm
- Contact Person Name
- Anna Tomaszuk-Kazberuk
- Contact Person Email
- a.tomaszuk@poczta.fm
Croatia
- Earliest CTIS Part Ii Submission Date
- 27-05-2025
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 342
- Number Of Sites
- 8
- Number Of Participants
- 110
Sites
- Site Name
- Klinicki bolnicki centar Sestre milosrdnice
- Department Name
- Institute for cardiomyopathies, heart failure and heart valve diseases
- Principal Investigator Name
- Kresimir Kordic
- Principal Investigator Email
- kordic.kresimir@yahoo.com
- Contact Person Name
- Kresimir Kordic
- Contact Person Email
- kordic.kresimir@yahoo.com
- Site Name
- University Hospital Centre Zagreb
- Department Name
- Department for Cardiovascular Diseases
- Principal Investigator Name
- Ivo Planinc
- Principal Investigator Email
- ivo.planinc@gmail.com
- Contact Person Name
- Ivo Planinc
- Contact Person Email
- ivo.planinc@gmail.com
- Site Name
- Klinicki Bolnicki Centar Osijek
- Department Name
- Department of Heart and Vascular Diseases
- Principal Investigator Name
- Marko Stupin
- Principal Investigator Email
- marko.stupin@gmail.com
- Contact Person Name
- Marko Stupin
- Contact Person Email
- marko.stupin@gmail.com
- Site Name
- Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
- Department Name
- Cardiac rehabilitation department
- Principal Investigator Name
- Krunoslav Fuckar
- Principal Investigator Email
- krunoslavf93@gmail.com
- Contact Person Name
- Krunoslav Fuckar
- Contact Person Email
- krunoslavf93@gmail.com
- Site Name
- Internacionalni medicinski centar PRIORA
- Department Name
- Department of Internal Medicine and Cardiology
- Principal Investigator Name
- Aleksandar Kibel
- Principal Investigator Email
- aleksandar_mf@yahoo.com
- Contact Person Name
- Aleksandar Kibel
- Contact Person Email
- aleksandar_mf@yahoo.com
- Site Name
- University Hospital Sveti Duh
- Department Name
- Department for Cardiovascular Diseases
- Principal Investigator Name
- Jasna Cerkez Habek
- Principal Investigator Email
- jasna.habek@gmail.com
- Contact Person Name
- Jasna Cerkez Habek
- Contact Person Email
- jasna.habek@gmail.com
- Site Name
- Clinical Hospital Centre Rijeka
- Department Name
- Clinic for heart and blood vessel diseases
- Principal Investigator Name
- Ivana Smoljan
- Principal Investigator Email
- ismoljan@yahoo.com
- Contact Person Name
- Ivana Smoljan
- Contact Person Email
- ismoljan@yahoo.com
- Site Name
- Opca Bolnica Varazdin
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Melita Jeric
- Principal Investigator Email
- melita.jeric@vz.t-com.hr
- Contact Person Name
- Melita Jeric
- Contact Person Email
- melita.jeric@vz.t-com.hr
Spain
- Earliest CTIS Part Ii Submission Date
- 17-03-2025
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 378
- Number Of Sites
- 17
- Number Of Participants
- 135
Sites
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Internal Medicine
- Principal Investigator Name
- Antonio Bustos Merlo
- Principal Investigator Email
- antoniobustosmerlo@gmail.com
- Contact Person Name
- Antonio Bustos Merlo
- Contact Person Email
- antoniobustosmerlo@gmail.com
- Site Name
- Hospital Universitario De Navarra
- Department Name
- Cardiology
- Principal Investigator Name
- Amaia Martínez León
- Principal Investigator Email
- amaiamtzleon@gmail.com
- Contact Person Name
- Amaia Martínez León
- Contact Person Email
- amaiamtzleon@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Cardiology
- Principal Investigator Name
- Luís Almenar Bonet
- Principal Investigator Email
- lualmenar@gmail.com
- Contact Person Name
- Luís Almenar Bonet
- Contact Person Email
- lualmenar@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Cardiology
- Principal Investigator Name
- José Manuel García Pinilla
- Principal Investigator Email
- marlucale41@gmail.com
- Contact Person Name
- José Manuel García Pinilla
- Contact Person Email
- marlucale41@gmail.com
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- Heart Failure and Pulmonary Hypertension Unit
- Principal Investigator Name
- Diego Ginés Segura-Rodríguez
- Principal Investigator Email
- diegoseguracardio@gmail.com
- Contact Person Name
- Diego Ginés Segura-Rodríguez
- Contact Person Email
- diegoseguracardio@gmail.com
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Cardiology
- Principal Investigator Name
- Aleix Fort Pal
- Principal Investigator Email
- afort.girona.ics@gencat.cat
- Contact Person Name
- Aleix Fort Pal
- Contact Person Email
- afort.girona.ics@gencat.cat
- Site Name
- Hospital Del Mar
- Department Name
- Heart Failure Unit
- Principal Investigator Name
- Sandra Valdivielso Moré
- Principal Investigator Email
- sandravm23@hotmail.com
- Contact Person Name
- Sandra Valdivielso Moré
- Contact Person Email
- sandravm23@hotmail.com
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Cardiology
- Principal Investigator Name
- Maria Generosa Crespo Leiro
- Principal Investigator Email
- Marisa.Crespo.Leiro@sergas.es
- Contact Person Name
- Maria Generosa Crespo Leiro
- Contact Person Email
- Marisa.Crespo.Leiro@sergas.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Cardiology
- Principal Investigator Name
- Alfonso Varela Román
- Principal Investigator Email
- alfonso.varela.roman@sergas.es
- Contact Person Name
- Alfonso Varela Román
- Contact Person Email
- alfonso.varela.roman@sergas.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Cardiology
- Principal Investigator Name
- Julio Núñez Villota
- Principal Investigator Email
- yulnunez@gmail.com
- Contact Person Name
- Julio Núñez Villota
- Contact Person Email
- yulnunez@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Cardiology
- Principal Investigator Name
- Marta Cobo Marcos
- Principal Investigator Email
- martacobomarcos@hotmail.com
- Contact Person Name
- Marta Cobo Marcos
- Contact Person Email
- martacobomarcos@hotmail.com
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- Cardiology
- Principal Investigator Name
- Mario Galvan Ruiz
- Principal Investigator Email
- mariogalvanr@hotmail.com
- Contact Person Name
- Mario Galvan Ruiz
- Contact Person Email
- mariogalvanr@hotmail.com
- Site Name
- Hospital De Manises
- Department Name
- Internal medicine
- Principal Investigator Name
- Maria Carmen Moreno García
- Principal Investigator Email
- mcmorenogarcia@gmail.com
- Contact Person Name
- Maria Carmen Moreno García
- Contact Person Email
- mcmorenogarcia@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Internal medicine
- Principal Investigator Name
- Pau Llàcer Iborra
- Principal Investigator Email
- paullacer@hotmail.com
- Contact Person Name
- Pau Llàcer Iborra
- Contact Person Email
- paullacer@hotmail.com
- Site Name
- Hospital Vithas Valencia Turia S.L.
- Department Name
- Cardiology
- Principal Investigator Name
- Alfonso Valle Muñoz
- Principal Investigator Email
- dr.alfonsovalle@gmail.com
- Contact Person Name
- Alfonso Valle Muñoz
- Contact Person Email
- dr.alfonsovalle@gmail.com
- Site Name
- Bellvitge University Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Cristina Enjuanes Grau
- Principal Investigator Email
- cristinaenjuanes@gmail.com
- Contact Person Name
- Cristina Enjuanes Grau
- Contact Person Email
- cristinaenjuanes@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Cardiology
- Principal Investigator Name
- Juan Ramón Rey Blas
- Principal Investigator Email
- jreyblas@hotmail.com
- Contact Person Name
- Juan Ramón Rey Blas
- Contact Person Email
- jreyblas@hotmail.com
Greece
- Earliest CTIS Part Ii Submission Date
- 17-03-2025
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 331
- Number Of Sites
- 11
- Number Of Participants
- 75
Sites
- Site Name
- Onassis Cardiac Surgery Center
- Department Name
- Dpt of Heart Failure and Transplantation
- Principal Investigator Name
- Michael Bonios
- Principal Investigator Email
- michael.bonios@hsc.utah.edu
- Contact Person Name
- Michael Bonios
- Contact Person Email
- michael.bonios@hsc.utah.edu
- Site Name
- Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
- Department Name
- 6th Cardiology Department
- Principal Investigator Name
- Elias Tsougos
- Principal Investigator Email
- ITsougkos@hygeia.gr
- Contact Person Name
- Elias Tsougos
- Contact Person Email
- ITsougkos@hygeia.gr
- Site Name
- University General Hospital Of Alexandroupoli
- Department Name
- University Cardiology Clinic
- Principal Investigator Name
- Dimitrios Tziakas
- Principal Investigator Email
- dtziakas@med.duth.gr
- Contact Person Name
- Dimitrios Tziakas
- Contact Person Email
- dtziakas@med.duth.gr
- Site Name
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
- Department Name
- 1st Cardiological Medicine Clinic and 5th Cardiological Medicine Clinic - Cardiology Dpt
- Principal Investigator Name
- Stefanos Foussas
- Principal Investigator Email
- sfoussas@gmail.com
- Contact Person Name
- Stefanos Foussas
- Contact Person Email
- sfoussas@gmail.com
- Site Name
- General Hospital Of Chios Skylitseio
- Department Name
- Cardiology Department
- Principal Investigator Name
- Athanasios Kartalis
- Principal Investigator Email
- gr.manager@xioshosp.gr
- Contact Person Name
- Athanasios Kartalis
- Contact Person Email
- gr.manager@xioshosp.gr
- Site Name
- University General Hospital of Larissa
- Department Name
- Cardiology Department
- Principal Investigator Name
- Grigorios Giamouzis
- Principal Investigator Email
- grgiamouzis@gmail.com
- Contact Person Name
- Grigorios Giamouzis
- Contact Person Email
- grgiamouzis@gmail.com
- Site Name
- General Hospital Of Nea Ionia Konstantopouleio Patision
- Department Name
- Cardiology Department
- Principal Investigator Name
- Sotirios Patsilinakos
- Principal Investigator Email
- spatsilinakos@Gmail.com
- Contact Person Name
- Sotirios Patsilinakos
- Contact Person Email
- spatsilinakos@Gmail.com
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- 1st Cardiology Clinic
- Principal Investigator Name
- Georgios Giannakoulas
- Principal Investigator Email
- g.giannakoulas@gmail.com
- Contact Person Name
- Georgios Giannakoulas
- Contact Person Email
- g.giannakoulas@gmail.com
- Site Name
- General Hospital Of Athens Alexandra
- Department Name
- Therapeutic Clinic & Lab of the Medical School of the National and Kapodistrian Uni of Athens
- Principal Investigator Name
- Alexandros Briasoulis
- Principal Investigator Email
- alexbriasoulis@gmail.com
- Contact Person Name
- Alexandros Briasoulis
- Contact Person Email
- alexbriasoulis@gmail.com
- Site Name
- Hippokration Hospital
- Department Name
- 1st Cardiology Clinic
- Principal Investigator Name
- Konstantinos Tsioufis
- Principal Investigator Email
- ktsioufis@gmail.com
- Contact Person Name
- Konstantinos Tsioufis
- Contact Person Email
- ktsioufis@gmail.com
- Site Name
- University General Hospital Attikon
- Department Name
- Cardiology Department
- Principal Investigator Name
- Gerasimos Filippatos
- Principal Investigator Email
- geros@otenet.gr
- Contact Person Name
- Gerasimos Filippatos
- Contact Person Email
- geros@otenet.gr
Italy
- Earliest CTIS Part Ii Submission Date
- 17-03-2025
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 331
- Number Of Sites
- 7
- Number Of Participants
- 70
Sites
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Cardiology Department
- Principal Investigator Name
- Laura Scelsi
- Principal Investigator Email
- l.scelsi@smatteo.pv.it
- Contact Person Name
- Laura Scelsi
- Contact Person Email
- l.scelsi@smatteo.pv.it
- Site Name
- Centro Cardiologico Monzino S.p.A.
- Department Name
- Heart Failure and Clinical Cardiology and Rehabilitation Department
- Principal Investigator Name
- Piergiuseppe Agostoni
- Principal Investigator Email
- pierguiseppe.agostini@cardiologicomonzino.it
- Contact Person Name
- Piergiuseppe Agostoni
- Contact Person Email
- pierguiseppe.agostini@cardiologicomonzino.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Cardiology 1
- Principal Investigator Name
- Michele Senni
- Principal Investigator Email
- msenni@asst-pg23.it
- Contact Person Name
- Michele Senni
- Contact Person Email
- msenni@asst-pg23.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Department of Advanced Biomedical Sciences
- Principal Investigator Name
- Giuseppe Esposito
- Principal Investigator Email
- espogiov@unina.it
- Contact Person Name
- Giuseppe Esposito
- Contact Person Email
- espogiov@unina.it
- Site Name
- Universita' Degli Studi Di Ferrara
- Department Name
- Cardiology Department
- Principal Investigator Name
- Alessandro Fucili
- Principal Investigator Email
- a.fucili@ospfe.it
- Contact Person Name
- Alessandro Fucili
- Contact Person Email
- a.fucili@ospfe.it
- Site Name
- Azienda Ospedaliero Universitaria Renato Dulbecco
- Department Name
- Geriatrics division
- Principal Investigator Name
- Angela Sciacqua
- Principal Investigator Email
- sciacqua@unicz.it
- Contact Person Name
- Angela Sciacqua
- Contact Person Email
- sciacqua@unicz.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Dep. of Medical and Surgical Specialities, Radiological Sciences and Public Health
- Principal Investigator Name
- Savina Nodari
- Principal Investigator Email
- savina.nodari@unibs.it
- Contact Person Name
- Savina Nodari
- Contact Person Email
- savina.nodari@unibs.it
Sponsor
Primary sponsor
- Full Name
- Colorado Prevention Center
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Emerald Clinical Trials B.V.
- Responsibilities
- codes: 1,2,5,8
Third parties
- {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"codes: 1,12,2,5","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Palantza Polyxeni Tou Konstantinou","duties_or_roles":"codes: 1,15; value for code 15: assistance with site selection and site management including but not limited to site budgets and contracts negotiations, Site Initiation Visit, overseeing safety reporting procedures at sites, site close out.","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Netherlands","full_name":"Emerald Clinical Trials B.V.","duties_or_roles":"codes: 1,2,5,8","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Placebo for bay 94-8862
- Modality
- Other
- Investigational Product Name
- BAY 94-8862
- Active Substance
- FINERENONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 20 mg
- Maximum Dose
- 20 mg
- Investigational Product Name
- Finerenone
- Active Substance
- FINERENONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 10 mg
- Maximum Dose
- 10 mg
- Investigational Product Name
- Finerenone
- Active Substance
- FINERENONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- 40 mg
- Maximum Dose
- 40 mg
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