Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04435626




Registration number
NCT04435626
Ethics application status
Date submitted
15/06/2020
Date registered
17/06/2020
Date last updated
28/05/2024

Titles & IDs
Public title
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%
Scientific title
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity and Mortality in Participants With Heart Failure (NYHA II-IV) and Left Ventricular Ejection Fraction = 40% (LVEF = 40%)
Secondary ID [1] 0 0
2020-000306-29
Secondary ID [2] 0 0
20103
Universal Trial Number (UTN)
Trial acronym
FINEARTS-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Finerenone (BAY94-8862)
Other interventions - Placebo

Experimental: Arm 1_BAY94-8862 - Adult patients receive BAY94-8862

Placebo Comparator: Arm 2_Placebo - Adult patients receive placebo


Treatment: Drugs: Finerenone (BAY94-8862)
For participants with an eGFR =60 mL/min/1.73 m^2: Starting dose is 10 mg OD and maximum dose 20 mg OD.
For participants with an eGFR >60 mL/min/1.73 m^2: Starting dose is 20 mg OD and maximum dose 40 mg OD. Finerenone is administered orally as immediate release tablets.

Other interventions: Placebo
Placebo tablets matching BAY94-8862 are administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of cardiovascular deaths and heart failure events
Timepoint [1] 0 0
Up to 42 months
Secondary outcome [1] 0 0
Time to total (first and recurrent) HF events
Timepoint [1] 0 0
Up to 42 months
Secondary outcome [2] 0 0
Improvement in NYHA class from Baseline to Month 12
Timepoint [2] 0 0
Up to 12 month after start of treatment
Secondary outcome [3] 0 0
Change in Total Symptom Score (TSS) from KCCQ.
Timepoint [3] 0 0
At baseline, Months 6, 9 and 12
Secondary outcome [4] 0 0
Time to first occurrence of composite renal endpoint
Timepoint [4] 0 0
Up to 42 months
Secondary outcome [5] 0 0
Time to death from any cause
Timepoint [5] 0 0
Up to 42 months

Eligibility
Key inclusion criteria
- Participant (male or female) must be aged 40 years and older.

- Diagnosis of heart failure with New York Heart Association(NYHA) class II-IV,
ambulatory or hospitalized primarily for heart failure.

- On diuretic treatment for at least 30 days prior to randomization.

- Documented left ventricular ejection fraction (LVEF) of =40% measured by any modality
within the last 12 months.

- Structural heart abnormalities based on any local imaging measurement within the last
12 months, defined by at least one of the following findings: left atrial diameter
(LAD) =3.8cm, left atrial area (LAA) =20cm2, left atrial volume index (LAVI) >30
mL/m2, left ventricular mass index (LVMI) =115 g/m2 (?)/ 95 g/m2 (?), septal thickness
or posterior wall thickness =1.1 cm

- n-terminal prohormone B-type natriuretic peptide (NT-proBNP) =300 pg/mL (BNP =100
pg/mL) in sinus rhythm and patient does not have an ongoing diagnosis of paroxysmal
atrial fibrillation or NT-proBNP =900 pg/mL (BNP =300 pg/mL) in atrial fibrillation
(or if atrial fibrillation status is unknown or if patient has an ongoing diagnosis of
paroxysmal atrial fibrillation) for participants obtained at the following time:

- Within 90 days prior to randomization if patient had been hospitalized for heart
failure (HF) requiring initiation or change in HF therapy or if patient had an
urgent visit for HF requiring intravenous (IV) diuretic therapy, both within 90
days prior to randomization OR

- Within 30 days prior to randomization if patient has not been hospitalized for HF
nor had an urgent HF visit within the past 90 days.

- Women of childbearing potential can only be included in the study if a pregnancy test
is negative at screening and baseline and if they agree to use adequate contraception
which is consistent with local regulations regarding the methods for contraception for
those participating in clinical trials.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m² at either screening or
randomization visit.

- Serum/plasma potassium >5.0 mmol/L at either screening or randomization visit.

- Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to
randomization

- Myocardial infarction or any event which could have reduced the ejection fraction
within 90 days prior to randomization

- Coronary artery bypass graft surgery in the 90 days prior to randomization

- Percutaneous coronary intervention in the 30 days prior to randomization

- Stroke or transient ischemic cerebral attack within 90 days prior to randomization

- Probable alternative cause of participants' HF symptoms that in the opinion of the
investigator primarily accounts for patient's dyspnea such as significant pulmonary
disease, anemia or obesity. Specifically, patients with the below are excluded: Severe
pulmonary disease requiring home oxygen, or chronic oral steroid therapy, History of
primary pulmonary arterial hypertension, Hemoglobin <10 g/dl, Valvular heart disease
considered by the investigator to be clinically significant, Body Mass Index (BMI) >50
kg/m2 at screening

- Systolic blood pressure(SBP) =160 mmHg if not on treatment with =3 blood pressure
lowering medications or =180 mmHg irrespective of treatments, on 2 consecutive
measurements at least 2-minute apart, at screening or at randomization.

- Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4)
inhibitors (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin) or
moderate or potent CYP3A4 inducers, that cannot be discontinued 7 days prior to
randomization and for the duration of the treatment period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/06/2024
Actual
Sample size
Target
Accrual to date
Final
6016
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
The Wesley Hospital - Auchenflower
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Advara HeartCare Leabrook - Leabrook
Recruitment hospital [6] 0 0
Advara HeartCare Ringwood - Bundoora
Recruitment hospital [7] 0 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4006 - Herston
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
5068 - Leabrook
Recruitment postcode(s) [6] 0 0
3083 - Bundoora
Recruitment postcode(s) [7] 0 0
4032 - Chermside
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
South Dakota
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Argentina
State/province [35] 0 0
Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
Ciudad Auton. De Buenos Aires
Country [37] 0 0
Argentina
State/province [37] 0 0
Santa Fe
Country [38] 0 0
Argentina
State/province [38] 0 0
Tucuman
Country [39] 0 0
Argentina
State/province [39] 0 0
Corrientes
Country [40] 0 0
Argentina
State/province [40] 0 0
Córdoba
Country [41] 0 0
Austria
State/province [41] 0 0
Kärnten
Country [42] 0 0
Austria
State/province [42] 0 0
Niederösterreich
Country [43] 0 0
Austria
State/province [43] 0 0
Oberösterreich
Country [44] 0 0
Austria
State/province [44] 0 0
Steiermark
Country [45] 0 0
Austria
State/province [45] 0 0
Vorarlberg
Country [46] 0 0
Austria
State/province [46] 0 0
Salzburg
Country [47] 0 0
Austria
State/province [47] 0 0
Wien
Country [48] 0 0
Brazil
State/province [48] 0 0
Bahia
Country [49] 0 0
Brazil
State/province [49] 0 0
Distrito Federal
Country [50] 0 0
Brazil
State/province [50] 0 0
Goiás
Country [51] 0 0
Brazil
State/province [51] 0 0
Parana
Country [52] 0 0
Brazil
State/province [52] 0 0
Rio Grande Do Sul
Country [53] 0 0
Brazil
State/province [53] 0 0
Santa Catarina
Country [54] 0 0
Brazil
State/province [54] 0 0
Sao Paulo
Country [55] 0 0
Brazil
State/province [55] 0 0
Sergipe
Country [56] 0 0
Brazil
State/province [56] 0 0
Campinas
Country [57] 0 0
Brazil
State/province [57] 0 0
Minas Gerais
Country [58] 0 0
Bulgaria
State/province [58] 0 0
Burgas
Country [59] 0 0
Bulgaria
State/province [59] 0 0
Haskovo
Country [60] 0 0
Bulgaria
State/province [60] 0 0
Pazardjik
Country [61] 0 0
Bulgaria
State/province [61] 0 0
Pernik
Country [62] 0 0
Bulgaria
State/province [62] 0 0
Pleven
Country [63] 0 0
Bulgaria
State/province [63] 0 0
Plovdiv
Country [64] 0 0
Bulgaria
State/province [64] 0 0
Shumen
Country [65] 0 0
Bulgaria
State/province [65] 0 0
Sliven
Country [66] 0 0
Bulgaria
State/province [66] 0 0
Sofia
Country [67] 0 0
Bulgaria
State/province [67] 0 0
Stara Zagora
Country [68] 0 0
Bulgaria
State/province [68] 0 0
Veliko Tarnovo
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Yambol
Country [70] 0 0
Canada
State/province [70] 0 0
British Columbia
Country [71] 0 0
Canada
State/province [71] 0 0
Manitoba
Country [72] 0 0
Canada
State/province [72] 0 0
New Brunswick
Country [73] 0 0
Canada
State/province [73] 0 0
Nova Scotia
Country [74] 0 0
Canada
State/province [74] 0 0
Ontario
Country [75] 0 0
Canada
State/province [75] 0 0
Quebec
Country [76] 0 0
China
State/province [76] 0 0
Fujian
Country [77] 0 0
China
State/province [77] 0 0
Gansu
Country [78] 0 0
China
State/province [78] 0 0
Guangdong
Country [79] 0 0
China
State/province [79] 0 0
Guizhou
Country [80] 0 0
China
State/province [80] 0 0
Hainan
Country [81] 0 0
China
State/province [81] 0 0
Hebei
Country [82] 0 0
China
State/province [82] 0 0
Heilongjiang
Country [83] 0 0
China
State/province [83] 0 0
Henan
Country [84] 0 0
China
State/province [84] 0 0
Hunan
Country [85] 0 0
China
State/province [85] 0 0
Jiangsu
Country [86] 0 0
China
State/province [86] 0 0
Jilin
Country [87] 0 0
China
State/province [87] 0 0
Liaoning
Country [88] 0 0
China
State/province [88] 0 0
Ningxia
Country [89] 0 0
China
State/province [89] 0 0
Shandong
Country [90] 0 0
China
State/province [90] 0 0
Shanxi
Country [91] 0 0
China
State/province [91] 0 0
Sichuan
Country [92] 0 0
China
State/province [92] 0 0
Xinjiang
Country [93] 0 0
China
State/province [93] 0 0
Zhejiang
Country [94] 0 0
China
State/province [94] 0 0
Beijing
Country [95] 0 0
China
State/province [95] 0 0
Shanghai
Country [96] 0 0
China
State/province [96] 0 0
Tianjin
Country [97] 0 0
Colombia
State/province [97] 0 0
Antioquia
Country [98] 0 0
Colombia
State/province [98] 0 0
Atlántico
Country [99] 0 0
Colombia
State/province [99] 0 0
Distrito Capital De Bogotá
Country [100] 0 0
Colombia
State/province [100] 0 0
Quindío
Country [101] 0 0
Colombia
State/province [101] 0 0
Santander
Country [102] 0 0
Colombia
State/province [102] 0 0
Tolima
Country [103] 0 0
Colombia
State/province [103] 0 0
Valle Del Cauca
Country [104] 0 0
Colombia
State/province [104] 0 0
Barranquilla
Country [105] 0 0
Colombia
State/province [105] 0 0
Bogota
Country [106] 0 0
Colombia
State/province [106] 0 0
Medellin
Country [107] 0 0
Colombia
State/province [107] 0 0
Santa Fe De Bogotá
Country [108] 0 0
Czechia
State/province [108] 0 0
Brno
Country [109] 0 0
Czechia
State/province [109] 0 0
Cesky Krumlov
Country [110] 0 0
Czechia
State/province [110] 0 0
Chlumec nad Cidlinou
Country [111] 0 0
Czechia
State/province [111] 0 0
Dolni Brezany
Country [112] 0 0
Czechia
State/province [112] 0 0
Hradec kralove
Country [113] 0 0
Czechia
State/province [113] 0 0
Kromeriz
Country [114] 0 0
Czechia
State/province [114] 0 0
Liberec
Country [115] 0 0
Czechia
State/province [115] 0 0
Louny
Country [116] 0 0
Czechia
State/province [116] 0 0
Pisek
Country [117] 0 0
Czechia
State/province [117] 0 0
Plzen
Country [118] 0 0
Czechia
State/province [118] 0 0
Podebrady
Country [119] 0 0
Czechia
State/province [119] 0 0
Praha 11 - Chodov
Country [120] 0 0
Czechia
State/province [120] 0 0
Praha 2
Country [121] 0 0
Czechia
State/province [121] 0 0
Praha 4
Country [122] 0 0
Czechia
State/province [122] 0 0
Praha 5
Country [123] 0 0
Czechia
State/province [123] 0 0
Praha 6
Country [124] 0 0
Czechia
State/province [124] 0 0
Trebic
Country [125] 0 0
Czechia
State/province [125] 0 0
Trinec
Country [126] 0 0
Czechia
State/province [126] 0 0
Zlin
Country [127] 0 0
Czechia
State/province [127] 0 0
Znojmo
Country [128] 0 0
Denmark
State/province [128] 0 0
Aarhus N
Country [129] 0 0
Denmark
State/province [129] 0 0
Esbjerg
Country [130] 0 0
Denmark
State/province [130] 0 0
Hellerup
Country [131] 0 0
Denmark
State/province [131] 0 0
Herlev
Country [132] 0 0
Denmark
State/province [132] 0 0
Herning
Country [133] 0 0
Denmark
State/province [133] 0 0
Holbæk
Country [134] 0 0
Denmark
State/province [134] 0 0
Hvidovre
Country [135] 0 0
Denmark
State/province [135] 0 0
Randers
Country [136] 0 0
Denmark
State/province [136] 0 0
Svendborg
Country [137] 0 0
Finland
State/province [137] 0 0
Espoo
Country [138] 0 0
Finland
State/province [138] 0 0
Tampere
Country [139] 0 0
Finland
State/province [139] 0 0
Turku
Country [140] 0 0
Germany
State/province [140] 0 0
Baden-Württemberg
Country [141] 0 0
Germany
State/province [141] 0 0
Bayern
Country [142] 0 0
Germany
State/province [142] 0 0
Niedersachsen
Country [143] 0 0
Germany
State/province [143] 0 0
Nordrhein-Westfalen
Country [144] 0 0
Greece
State/province [144] 0 0
Attica
Country [145] 0 0
Greece
State/province [145] 0 0
Alexandroupoli
Country [146] 0 0
Greece
State/province [146] 0 0
Ampelokipi - Athens
Country [147] 0 0
Greece
State/province [147] 0 0
Athens
Country [148] 0 0
Greece
State/province [148] 0 0
Chaidari
Country [149] 0 0
Greece
State/province [149] 0 0
Heraklion
Country [150] 0 0
Greece
State/province [150] 0 0
Larissa
Country [151] 0 0
Greece
State/province [151] 0 0
Nea Ionia / Athens
Country [152] 0 0
Greece
State/province [152] 0 0
Patra
Country [153] 0 0
Greece
State/province [153] 0 0
Thessaloniki
Country [154] 0 0
Hong Kong
State/province [154] 0 0
N.T
Country [155] 0 0
Hong Kong
State/province [155] 0 0
Hong Kong
Country [156] 0 0
Hong Kong
State/province [156] 0 0
Kowloon
Country [157] 0 0
Hong Kong
State/province [157] 0 0
Lai Chi Kok
Country [158] 0 0
Hungary
State/province [158] 0 0
Balatonfured
Country [159] 0 0
Hungary
State/province [159] 0 0
Budapest
Country [160] 0 0
Hungary
State/province [160] 0 0
Gyongyos
Country [161] 0 0
Hungary
State/province [161] 0 0
Hodmezovasarhely
Country [162] 0 0
Hungary
State/province [162] 0 0
Miskolc
Country [163] 0 0
Hungary
State/province [163] 0 0
Nagykanizsa
Country [164] 0 0
Hungary
State/province [164] 0 0
Nyiregyhaza
Country [165] 0 0
Hungary
State/province [165] 0 0
Pecs
Country [166] 0 0
Hungary
State/province [166] 0 0
Szeged
Country [167] 0 0
Hungary
State/province [167] 0 0
Szekesfehervar
Country [168] 0 0
Hungary
State/province [168] 0 0
Szekszard
Country [169] 0 0
Hungary
State/province [169] 0 0
Szentes
Country [170] 0 0
India
State/province [170] 0 0
Delhi
Country [171] 0 0
India
State/province [171] 0 0
Maharashtra
Country [172] 0 0
India
State/province [172] 0 0
Tamil Nadu
Country [173] 0 0
Israel
State/province [173] 0 0
Ashdod
Country [174] 0 0
Israel
State/province [174] 0 0
Ashkelon
Country [175] 0 0
Israel
State/province [175] 0 0
Haifa
Country [176] 0 0
Israel
State/province [176] 0 0
Jerusalem
Country [177] 0 0
Israel
State/province [177] 0 0
Kfar Saba
Country [178] 0 0
Israel
State/province [178] 0 0
Lower Galilee
Country [179] 0 0
Israel
State/province [179] 0 0
Nahariya
Country [180] 0 0
Israel
State/province [180] 0 0
Ramat Gan
Country [181] 0 0
Israel
State/province [181] 0 0
Rehovot
Country [182] 0 0
Israel
State/province [182] 0 0
Tel Aviv
Country [183] 0 0
Israel
State/province [183] 0 0
Zefat
Country [184] 0 0
Israel
State/province [184] 0 0
Zrifin
Country [185] 0 0
Italy
State/province [185] 0 0
Calabria
Country [186] 0 0
Italy
State/province [186] 0 0
Campania
Country [187] 0 0
Italy
State/province [187] 0 0
Emilia-Romagna
Country [188] 0 0
Italy
State/province [188] 0 0
Lombardia
Country [189] 0 0
Italy
State/province [189] 0 0
Piemonte
Country [190] 0 0
Italy
State/province [190] 0 0
Toscana
Country [191] 0 0
Italy
State/province [191] 0 0
Umbria
Country [192] 0 0
Italy
State/province [192] 0 0
Veneto
Country [193] 0 0
Japan
State/province [193] 0 0
Aichi
Country [194] 0 0
Japan
State/province [194] 0 0
Chiba
Country [195] 0 0
Japan
State/province [195] 0 0
Fukuoka
Country [196] 0 0
Japan
State/province [196] 0 0
Gifu
Country [197] 0 0
Japan
State/province [197] 0 0
Hiroshima
Country [198] 0 0
Japan
State/province [198] 0 0
Hyogo
Country [199] 0 0
Japan
State/province [199] 0 0
Ibaraki
Country [200] 0 0
Japan
State/province [200] 0 0
Ishikawa
Country [201] 0 0
Japan
State/province [201] 0 0
Iwate
Country [202] 0 0
Japan
State/province [202] 0 0
Kagawa
Country [203] 0 0
Japan
State/province [203] 0 0
Kanagawa
Country [204] 0 0
Japan
State/province [204] 0 0
Nagano
Country [205] 0 0
Japan
State/province [205] 0 0
Okinawa
Country [206] 0 0
Japan
State/province [206] 0 0
Osaka
Country [207] 0 0
Japan
State/province [207] 0 0
Saitama
Country [208] 0 0
Japan
State/province [208] 0 0
Shimane
Country [209] 0 0
Japan
State/province [209] 0 0
Tokyo
Country [210] 0 0
Japan
State/province [210] 0 0
Tottori
Country [211] 0 0
Japan
State/province [211] 0 0
Yamaguchi
Country [212] 0 0
Japan
State/province [212] 0 0
Kumamoto
Country [213] 0 0
Japan
State/province [213] 0 0
Miyazaki
Country [214] 0 0
Japan
State/province [214] 0 0
Niigata
Country [215] 0 0
Japan
State/province [215] 0 0
Oita
Country [216] 0 0
Japan
State/province [216] 0 0
Okayama
Country [217] 0 0
Japan
State/province [217] 0 0
Toyama
Country [218] 0 0
Japan
State/province [218] 0 0
Wakayama
Country [219] 0 0
Korea, Republic of
State/province [219] 0 0
Chungcheongbugdo
Country [220] 0 0
Korea, Republic of
State/province [220] 0 0
Gang''weondo
Country [221] 0 0
Korea, Republic of
State/province [221] 0 0
Gyeonggido
Country [222] 0 0
Korea, Republic of
State/province [222] 0 0
Busan
Country [223] 0 0
Korea, Republic of
State/province [223] 0 0
Daejeon
Country [224] 0 0
Korea, Republic of
State/province [224] 0 0
Gwangju
Country [225] 0 0
Korea, Republic of
State/province [225] 0 0
Seoul
Country [226] 0 0
Latvia
State/province [226] 0 0
Daugavpils
Country [227] 0 0
Latvia
State/province [227] 0 0
Jelgava
Country [228] 0 0
Latvia
State/province [228] 0 0
Liepaja
Country [229] 0 0
Latvia
State/province [229] 0 0
Riga
Country [230] 0 0
Latvia
State/province [230] 0 0
Ventspils
Country [231] 0 0
Lithuania
State/province [231] 0 0
Alytus
Country [232] 0 0
Lithuania
State/province [232] 0 0
Kaunas
Country [233] 0 0
Lithuania
State/province [233] 0 0
Klaipeda
Country [234] 0 0
Lithuania
State/province [234] 0 0
Siauliai
Country [235] 0 0
Lithuania
State/province [235] 0 0
Vilnius
Country [236] 0 0
Malaysia
State/province [236] 0 0
George Town,
Country [237] 0 0
Malaysia
State/province [237] 0 0
Kuala Lumpur
Country [238] 0 0
Malaysia
State/province [238] 0 0
Perak
Country [239] 0 0
Malaysia
State/province [239] 0 0
Pulau Pinang
Country [240] 0 0
Malaysia
State/province [240] 0 0
Sarawak
Country [241] 0 0
Malaysia
State/province [241] 0 0
Selangor
Country [242] 0 0
Mexico
State/province [242] 0 0
Coahuila
Country [243] 0 0
Mexico
State/province [243] 0 0
Distrito Federal
Country [244] 0 0
Mexico
State/province [244] 0 0
Guerrero
Country [245] 0 0
Mexico
State/province [245] 0 0
Jalisco
Country [246] 0 0
Mexico
State/province [246] 0 0
Querétaro
Country [247] 0 0
Mexico
State/province [247] 0 0
Veracruz
Country [248] 0 0
Mexico
State/province [248] 0 0
Aguascalientes
Country [249] 0 0
Mexico
State/province [249] 0 0
Durango
Country [250] 0 0
Netherlands
State/province [250] 0 0
Almelo
Country [251] 0 0
Netherlands
State/province [251] 0 0
Blaricum
Country [252] 0 0
Netherlands
State/province [252] 0 0
Deventer
Country [253] 0 0
Netherlands
State/province [253] 0 0
Doetinchem
Country [254] 0 0
Netherlands
State/province [254] 0 0
Ede
Country [255] 0 0
Netherlands
State/province [255] 0 0
Eindhoven
Country [256] 0 0
Netherlands
State/province [256] 0 0
Groningen
Country [257] 0 0
Netherlands
State/province [257] 0 0
Harderwijk
Country [258] 0 0
Netherlands
State/province [258] 0 0
Maastricht
Country [259] 0 0
Netherlands
State/province [259] 0 0
Meppel
Country [260] 0 0
Netherlands
State/province [260] 0 0
Sneek
Country [261] 0 0
Netherlands
State/province [261] 0 0
Veldhoven
Country [262] 0 0
New Zealand
State/province [262] 0 0
Auckland
Country [263] 0 0
New Zealand
State/province [263] 0 0
Christchurch
Country [264] 0 0
New Zealand
State/province [264] 0 0
Dunedin
Country [265] 0 0
New Zealand
State/province [265] 0 0
Hawkes Bay
Country [266] 0 0
New Zealand
State/province [266] 0 0
Lower Hutt
Country [267] 0 0
New Zealand
State/province [267] 0 0
Nelson
Country [268] 0 0
New Zealand
State/province [268] 0 0
Tauranga
Country [269] 0 0
Poland
State/province [269] 0 0
Bialystok
Country [270] 0 0
Poland
State/province [270] 0 0
Bydgoszcz
Country [271] 0 0
Poland
State/province [271] 0 0
Gdynia
Country [272] 0 0
Poland
State/province [272] 0 0
Grodzisk Mazowiecki
Country [273] 0 0
Poland
State/province [273] 0 0
Katowice
Country [274] 0 0
Poland
State/province [274] 0 0
Krakow
Country [275] 0 0
Poland
State/province [275] 0 0
Lublin
Country [276] 0 0
Poland
State/province [276] 0 0
Olsztyn
Country [277] 0 0
Poland
State/province [277] 0 0
Oswiecim
Country [278] 0 0
Poland
State/province [278] 0 0
Poznan
Country [279] 0 0
Poland
State/province [279] 0 0
Pulawy
Country [280] 0 0
Poland
State/province [280] 0 0
Sopot
Country [281] 0 0
Poland
State/province [281] 0 0
Szczecin
Country [282] 0 0
Poland
State/province [282] 0 0
Torun
Country [283] 0 0
Portugal
State/province [283] 0 0
Braga
Country [284] 0 0
Portugal
State/province [284] 0 0
Castelo Branco
Country [285] 0 0
Portugal
State/province [285] 0 0
Porto
Country [286] 0 0
Portugal
State/province [286] 0 0
Setúbal
Country [287] 0 0
Portugal
State/province [287] 0 0
Amadora
Country [288] 0 0
Portugal
State/province [288] 0 0
Aveiro
Country [289] 0 0
Portugal
State/province [289] 0 0
Coimbra
Country [290] 0 0
Portugal
State/province [290] 0 0
Guarda
Country [291] 0 0
Portugal
State/province [291] 0 0
Leiria
Country [292] 0 0
Portugal
State/province [292] 0 0
Lisboa
Country [293] 0 0
Romania
State/province [293] 0 0
Mures
Country [294] 0 0
Romania
State/province [294] 0 0
Timis
Country [295] 0 0
Romania
State/province [295] 0 0
Baia Mare
Country [296] 0 0
Romania
State/province [296] 0 0
Braila
Country [297] 0 0
Romania
State/province [297] 0 0
Brasov
Country [298] 0 0
Romania
State/province [298] 0 0
Bucharest
Country [299] 0 0
Romania
State/province [299] 0 0
Bucuresti
Country [300] 0 0
Romania
State/province [300] 0 0
Craiova Dolj
Country [301] 0 0
Romania
State/province [301] 0 0
Galati
Country [302] 0 0
Romania
State/province [302] 0 0
Iasi
Country [303] 0 0
Romania
State/province [303] 0 0
Pitesti
Country [304] 0 0
Romania
State/province [304] 0 0
Targu Mures
Country [305] 0 0
Romania
State/province [305] 0 0
Timisoara
Country [306] 0 0
Russian Federation
State/province [306] 0 0
Aramil
Country [307] 0 0
Russian Federation
State/province [307] 0 0
Arkhangelsk
Country [308] 0 0
Russian Federation
State/province [308] 0 0
Barnaul
Country [309] 0 0
Russian Federation
State/province [309] 0 0
Chita
Country [310] 0 0
Russian Federation
State/province [310] 0 0
Izhevsk
Country [311] 0 0
Russian Federation
State/province [311] 0 0
Kazan
Country [312] 0 0
Russian Federation
State/province [312] 0 0
Kemerovo
Country [313] 0 0
Russian Federation
State/province [313] 0 0
Kirov
Country [314] 0 0
Russian Federation
State/province [314] 0 0
Moscow
Country [315] 0 0
Russian Federation
State/province [315] 0 0
Novosibirsk
Country [316] 0 0
Russian Federation
State/province [316] 0 0
Omsk
Country [317] 0 0
Russian Federation
State/province [317] 0 0
Penza
Country [318] 0 0
Russian Federation
State/province [318] 0 0
Perm
Country [319] 0 0
Russian Federation
State/province [319] 0 0
Rostov-on-Don
Country [320] 0 0
Russian Federation
State/province [320] 0 0
Ryazan
Country [321] 0 0
Russian Federation
State/province [321] 0 0
Samara
Country [322] 0 0
Russian Federation
State/province [322] 0 0
Saratov
Country [323] 0 0
Russian Federation
State/province [323] 0 0
St. Petersburg
Country [324] 0 0
Russian Federation
State/province [324] 0 0
Tomsk
Country [325] 0 0
Russian Federation
State/province [325] 0 0
Yekaterinburg
Country [326] 0 0
Slovakia
State/province [326] 0 0
Banska Bystrica
Country [327] 0 0
Slovakia
State/province [327] 0 0
Bardejov
Country [328] 0 0
Slovakia
State/province [328] 0 0
Bratislava 37
Country [329] 0 0
Slovakia
State/province [329] 0 0
Bratislava
Country [330] 0 0
Slovakia
State/province [330] 0 0
Brezno
Country [331] 0 0
Slovakia
State/province [331] 0 0
Dolny Kubin
Country [332] 0 0
Slovakia
State/province [332] 0 0
Kosice
Country [333] 0 0
Slovakia
State/province [333] 0 0
Levice
Country [334] 0 0
Slovakia
State/province [334] 0 0
Lucenec
Country [335] 0 0
Slovakia
State/province [335] 0 0
Moldava nad Bodvou
Country [336] 0 0
Slovakia
State/province [336] 0 0
Nitra
Country [337] 0 0
Slovakia
State/province [337] 0 0
Nove Zamky
Country [338] 0 0
Slovakia
State/province [338] 0 0
Presov
Country [339] 0 0
Slovakia
State/province [339] 0 0
Sahy
Country [340] 0 0
Slovakia
State/province [340] 0 0
Zilina
Country [341] 0 0
Spain
State/province [341] 0 0
A Coruña
Country [342] 0 0
Spain
State/province [342] 0 0
Alicante
Country [343] 0 0
Spain
State/province [343] 0 0
Asturias
Country [344] 0 0
Spain
State/province [344] 0 0
Barcelona
Country [345] 0 0
Spain
State/province [345] 0 0
Cádiz
Country [346] 0 0
Spain
State/province [346] 0 0
Las Palmas
Country [347] 0 0
Spain
State/province [347] 0 0
Málaga
Country [348] 0 0
Spain
State/province [348] 0 0
Sevilla
Country [349] 0 0
Spain
State/province [349] 0 0
Granada
Country [350] 0 0
Spain
State/province [350] 0 0
Lleida
Country [351] 0 0
Spain
State/province [351] 0 0
Madrid
Country [352] 0 0
Spain
State/province [352] 0 0
Salvador
Country [353] 0 0
Spain
State/province [353] 0 0
Valencia
Country [354] 0 0
Taiwan
State/province [354] 0 0
Kaohsiung
Country [355] 0 0
Taiwan
State/province [355] 0 0
Changhua
Country [356] 0 0
Taiwan
State/province [356] 0 0
Hsinchu
Country [357] 0 0
Taiwan
State/province [357] 0 0
Taichung
Country [358] 0 0
Taiwan
State/province [358] 0 0
Taipei
Country [359] 0 0
Taiwan
State/province [359] 0 0
Tao-Yuan
Country [360] 0 0
Turkey
State/province [360] 0 0
Afyonkarahisar
Country [361] 0 0
Turkey
State/province [361] 0 0
Antalya
Country [362] 0 0
Turkey
State/province [362] 0 0
Edirne
Country [363] 0 0
Turkey
State/province [363] 0 0
Eskisehir
Country [364] 0 0
Turkey
State/province [364] 0 0
Istanbul
Country [365] 0 0
Turkey
State/province [365] 0 0
Izmir
Country [366] 0 0
Turkey
State/province [366] 0 0
Kayseri
Country [367] 0 0
Turkey
State/province [367] 0 0
Kocaeli
Country [368] 0 0
Turkey
State/province [368] 0 0
Konya
Country [369] 0 0
Turkey
State/province [369] 0 0
Kutahya
Country [370] 0 0
Turkey
State/province [370] 0 0
Mersin
Country [371] 0 0
Ukraine
State/province [371] 0 0
Cherkasy
Country [372] 0 0
Ukraine
State/province [372] 0 0
Dnipro
Country [373] 0 0
Ukraine
State/province [373] 0 0
Kharkiv
Country [374] 0 0
Ukraine
State/province [374] 0 0
Kiev
Country [375] 0 0
Ukraine
State/province [375] 0 0
Kyiv
Country [376] 0 0
Ukraine
State/province [376] 0 0
Lviv
Country [377] 0 0
Ukraine
State/province [377] 0 0
Poltava
Country [378] 0 0
Ukraine
State/province [378] 0 0
Uzhgorod
Country [379] 0 0
Ukraine
State/province [379] 0 0
Vinnytsia
Country [380] 0 0
Ukraine
State/province [380] 0 0
Vinnytsya
Country [381] 0 0
Ukraine
State/province [381] 0 0
Zaporizhzhja
Country [382] 0 0
Ukraine
State/province [382] 0 0
Zaporizhzhya
Country [383] 0 0
Ukraine
State/province [383] 0 0
Zhytomyr
Country [384] 0 0
United Kingdom
State/province [384] 0 0
Dorset
Country [385] 0 0
United Kingdom
State/province [385] 0 0
Glasgow City
Country [386] 0 0
United Kingdom
State/province [386] 0 0
Hampshire
Country [387] 0 0
United Kingdom
State/province [387] 0 0
Hertfordshire
Country [388] 0 0
United Kingdom
State/province [388] 0 0
Lancashire
Country [389] 0 0
United Kingdom
State/province [389] 0 0
Leicestershire
Country [390] 0 0
United Kingdom
State/province [390] 0 0
Northumberland
Country [391] 0 0
United Kingdom
State/province [391] 0 0
West Midlands
Country [392] 0 0
United Kingdom
State/province [392] 0 0
West Sussex
Country [393] 0 0
United Kingdom
State/province [393] 0 0
Cottingham
Country [394] 0 0
United Kingdom
State/province [394] 0 0
Glasgow
Country [395] 0 0
United Kingdom
State/province [395] 0 0
Manchester
Country [396] 0 0
United Kingdom
State/province [396] 0 0
Swindon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the effect of finerenone compared to placebo (a
tablet without active substance) in the reduction of cardiovascular death (generally meaning
death due to disease of the heart or blood vessels) and total Heart Failure (HF) events,
including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or
urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in
patients suffering from HF with an ejection fraction greater than or equal to 40%.
Researchers will also collect information on how much the heart disease has impact on
patient's lives, change of kidney function, and how well finerenone treatment is tolerated.
The study plans to enroll 6000 male and female patients of the age of 40 years and above
suffering from heart failure with ejection fraction greater than or equal to 40%.
Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg
once daily. Study duration will be up to 43 months.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04435626
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04435626