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%

  • STATUS
    Recruiting
  • End date
    May 2, 2024
  • participants needed
    5500
  • sponsor
    Bayer
Updated on 22 September 2021
stroke
ejection fraction
heart failure
heart disease
nt-probnp
b-type natriuretic peptide
diuretic therapy
natriuretic peptide

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.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease
Treatment Placebo, Finerenone (BAY94-8862)
Clinical Study IdentifierNCT04435626
SponsorBayer
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m 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
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