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%)
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%)
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.
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:
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:
Tucson, Arizona 85724, United States
Gainesville, Florida 32608, United States
Wellington, Florida 33449, United States
Elkhart, Indiana 46514, United States
Riverhead, New York 11901, United States
Valley Stream, New York 11580, United States
Ciudad Autónoma de Buenos Aire, Buenos Aires C1056ABI, Argentina
Lanus, Buenos Aires B1824, Argentina
Zárate, Buenos Aires B2800DGH, Argentina
Buenos Aires, Buenos Aires F.D. C1428ART, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires 1426, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires C1440CFD, Argentina
CABA, Ciudad Auton. de Buenos Aires C1018DES, Argentina
Rosario, Santa Fe Province 2000, Argentina
Rosario, Santa Fe Province S2000DEJ, Argentina
Corrientes, 3400, Argentina
Goiânia, Goiás 74605-020, Brazil
Curitiba, Paraná 80045-170, Brazil
Paraná, Paraná 83430-000, Brazil
Porto Alegre, Rio Grande do Sul 90035-903, Brazil
Porto Alegre, Rio Grande do Sul 91350-280, Brazil
Campinas, São Paulo 13060-080, Brazil
Pernik, 2300, Bulgaria
Plovdiv, 4004, Bulgaria
Shumen, 9700, Bulgaria
Sofia, 1233, Bulgaria
Sofia, 1309, Bulgaria
Sofia, 1404, Bulgaria
Veliko Tarnovo, 5000, Bulgaria
Yambol, 8600, Bulgaria
Halifax, Nova Scotia B3H 3A7, Canada
North York, Ontario M6B 3H7, Canada
Baranquilla, Atlántico 080020, Colombia
Prague, 12808, Czechia
Praha 11 - Chodov, 148 00, Czechia
Århus N, 8200, Denmark
Svendborg, 5700, Denmark
Ampelokipi - Athens, 11526, Greece
Thessaloniki, 54642, Greece
Hódmezővásárhely, 6800, Hungary
Székesfehérvár, 8000, Hungary
Berlin, Maharashtra 10365, India
Naples, Campania 80131, Italy
Bologna, Emilia-Romagna 40133, Italy
Bologna, Emilia-Romagna 40138, Italy
Bergamo, Lombardy 24127, Italy
Brescia, Lombardy 25123, Italy
Monza Brianza, Lombardy 20832, Italy
Vimercate, Lombardy 20871, Italy
Perugia, Umbria 06129, Italy
Verona, Veneto 37126, Italy
Onga-gun, Fukuoka 811-4342, Japan
Hakusan, Ishikawa-ken 924-8588, Japan
Kanazawa, Ishikawa-ken 920-8650, Japan
Adachi-ku, Tokyo 123-0845, Japan
Meguro-ku, Tokyo 152-8902, Japan
Yonago, Tottori 683-8605, Japan
Sarawak, 94300, Malaysia
Alcaldia Gustavo A. Madero, Mexico City 7300, Mexico
Alcaldía Cuauhtemoc, Mexico City 6090, Mexico
Hawkes Bay, 4130, New Zealand
Grodzisk Mazowiecki, 05 825, Poland
Guimaraes, Braga, Braga District 4835-044, Portugal
Covilha, Castelo Branco District 6200-251, Portugal
Matosinhos Municipality, Porto District 4464-513, Portugal
Setúbal, Setúbal District 2900-722, Portugal
Aveiro, 3810-501, Portugal
Coimbra, 3004-561, Portugal
Craiova Dolj, 200642, Romania
Ferrol, A Coruña 15405, Spain
Las Palmas de Gran Canaria, Las Palmas 35010, Spain
Lleida, 25198, Spain
Cherkasy, 18009, Ukraine
Dnipro, 49006, Ukraine
Kharkiv, 61039, Ukraine
Kharkiv, 61166, Ukraine
Kharkiv, 61176, Ukraine
Kiev, 02 091, Ukraine
Kyiv, 03151, Ukraine
Kyiv, 03151, Ukraine
Kyiv, 03151, Ukraine
Lviv, 79015, Ukraine
Zaporizhzhya, 69005, Ukraine
Zhytomyr, 10002, Ukraine
Dudley, West Midlands DY1 2HQ, United Kingdom
Chichester, West Sussex PO19 6SE, United Kingdom
Cottingham, HU16 5JQ, United Kingdom
Glasgow, G31 2ER, United Kingdom