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Completed

NCT Number: NCT04435626

Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina, Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

finerenone (BAY94-8862)

Drug

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.

Placebo

Other

Placebo tablets matching BAY94-8862 are administered orally.

Primary outcomes

  1. Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events

    Time frame: From randomization up until the end of study, with an average study duration of 32 months

    Number of composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.

  2. Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events

    Time frame: From randomization up until the end of study, with an average study duration of 32 months

    Number of participants with composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.

Secondary outcomes

  1. Occurrence of Total (First and Recurrent) Heart Failure Events

    Time frame: From randomization up until the end of study, with an average study duration of 32 months

    Number of total (first and recurrent) heart failure events.

  2. Occurrence of Total (First and Recurrent) Heart Failure Events

    Time frame: From randomization up until the end of study, with an average study duration of 32 months

    Number of participants with total (first and recurrent) heart failure events.

  3. Change From Baseline in Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: From baseline to Month 6, 9 and 12

    The Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) is ranged from 0 to 100. A higher score (closer to 100) reflects fewer symptoms, indicating better heart failure symptom status.

    For the change from baseline the combined and averaged result across the entire time frame is reported.

  4. Proportion of Participants Who Showed Improvement in NHYA Class

    Time frame: from baseline to Month 12

    The New York Heart Association (NYHA) Functional Classification is a simple scale that classifies patients with heart failure based on the severity of their symptoms and how those symptoms affect their physical activity, which ranges from Class I to Class IV, a lower class number is indicative of a better condition. A patient was considered as having improved in NYHA class, if the NYHA class at Month 12 is at least one category improved compared to the baseline visit.

  5. First Occurrence of Renal Composite Events

    Time frame: From randomization up to end of study visit, with an average study duration of 32 months

    Number of participants with renal composite events encompassing the components sustained decrease in eGFR ≥50% relative to baseline over at least 4 weeks, sustained eGFR decline to <15 mL/min/1.73 m2 over at least 4 weeks, initiation of chronic dialysis and renal transplantation.

  6. Occurence of All-cause Mortality (Full Analysis Set)

    Time frame: From randomization until end of study, with an average of 32 months

    Number of participants with death due to any cause were reported as descriptive result. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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%)

Acronym: FINEARTS-HF

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2020
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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