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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04435626
Ethics application status
Date submitted
15/06/2020
Date registered
17/06/2020

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
Completed
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
Actual
14/06/2024
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
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5068 - Leabrook
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3083 - Bundoora
Recruitment postcode(s) [7] 0 0
4032 - Chermside
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Country [202] 0 0
Japan
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Kagawa
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Japan
State/province [203] 0 0
Kanagawa
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Japan
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Nagano
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Japan
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Okinawa
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Japan
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Osaka
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Japan
State/province [207] 0 0
Saitama
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Japan
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Shimane
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Japan
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Tokyo
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Japan
State/province [210] 0 0
Tottori
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Japan
State/province [211] 0 0
Yamaguchi
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Japan
State/province [212] 0 0
Kumamoto
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Japan
State/province [213] 0 0
Miyazaki
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Japan
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Niigata
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Japan
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Oita
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Japan
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Japan
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Toyama
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Japan
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Korea, Republic of
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Chungcheongbugdo
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Korea, Republic of
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Gang''weondo
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Daugavpils
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Latvia
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Jelgava
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Liepaja
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Latvia
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Riga
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Latvia
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Ventspils
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Lithuania
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Alytus
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Siauliai
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Lithuania
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Vilnius
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Malaysia
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George Town,
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Malaysia
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Kuala Lumpur
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Malaysia
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Perak
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Malaysia
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Pulau Pinang
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Malaysia
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Sarawak
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Malaysia
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Mexico
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Distrito Federal
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Mexico
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Guerrero
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Mexico
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Jalisco
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Mexico
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Querétaro
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Mexico
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Veracruz
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Mexico
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Mexico
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Durango
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Netherlands
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Almelo
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Netherlands
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Blaricum
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Netherlands
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Deventer
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Netherlands
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Doetinchem
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Netherlands
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Ede
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Netherlands
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Eindhoven
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Netherlands
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Groningen
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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
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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
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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
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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 scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. 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.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04435626