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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
Date last updated
3/07/2024

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
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
Recruitment postcode(s) [5] 0 0
5068 - Leabrook
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3083 - Bundoora
Recruitment postcode(s) [7] 0 0
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 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/study/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/study/NCT04435626