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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04435626
Ethics application status
Date submitted
15/06/2020
Date registered
17/06/2020
Date last updated
19/04/2021

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 - Composite endpoint. Heart Failure events comprise first and recurrent events
Timepoint [1] 0 0
Up to 42 months
Secondary outcome [1] 0 0
Change in Total Symptom Score (TSS) from KCCQ. - Patient Reported Outcomes measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Timepoint [1] 0 0
At baseline, Months 6, 9 and 12
Secondary outcome [2] 0 0
Time to first occurrence of composite renal endpoint - Composite renal endpoint: sustained decrease in estimated glomerular filtration rate (eGFR) =40% relative to baseline over at least 4 weeks, or sustained eGFR decline <15ml/min/1.73m2 or initiation of dialysis or renal transplantation.
Timepoint [2] 0 0
Up to 42 months
Secondary outcome [3] 0 0
Time to death from any cause
Timepoint [3] 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 B-type
natriuretic peptide (BNP = 100 pg/mL) in SR or NT-proBNP =900pg/mL (BNP = 300 pg/mL)
in atrial fibrillation (AF) 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
Gender
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.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
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Gosford Hospital - Gosford
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John Hunter Hospital - New Lambton Heights
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The Wesley Hospital - Auchenflower
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Royal Brisbane and Women's Hospital - Brisbane
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Gold Coast University Hospital - Gold Coast
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Flinders Medical Centre - Adelaide
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GenesisCare Leabrook - Leabrook
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GenesisCare Ringwood - Bundoora
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The Prince Charles Hospital - Chermside
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2050 - Camperdown
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2250 - Gosford
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2305 - New Lambton Heights
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4066 - Auchenflower
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4029 - Brisbane
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4215 - Gold Coast
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5042 - Adelaide
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5068 - Leabrook
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3083 - Bundoora
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4032 - Chermside
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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 5500 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/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
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
clinical-trials-contact@bayer.com
Contact person for scientific queries

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