A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.
Inclusion criteria:
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
Signed and dated written ICF (Informed Consent Form)
Further inclusion criteria apply
Exclusion criteria:
Chapel Hill, North Carolina 27599-5021, United States
CABA, C1119ACN, Argentina
CABA, C1199ABB, Argentina
Ciudad Autonoma Buenos Aires, C1425AGC, Argentina
Ciudad Autonoma Buenos Aires, C1428ART, Argentina
Ciudad Autonoma Buenos Aires, C1430CKE, Argentina
Ciudad Autonoma de Bs As, C1120AAC, Argentina
Ciudad Autónoma de Bs As, C1180AAX, Argentina
Caxias do Sul, 95070-560, Brazil
Rio de Janeiro - RJ, CEP 20551, Brazil
Longeuil, Quebec J4M 2X1, Canada
Saint George-de-Beauce, Quebec G5Y 4T8, Canada
Brandys Nad, 250 01, Czechia
Praha 4 - Krc, 140 59, Czechia
Aichi, Kasugai, 486-8510, Japan
Aichi, Nagoya, 454-0933, Japan
Aichi, Nagoya, 466-8650, Japan
Aichi, Toyota, 471-8513, Japan
Chiba, Chiba, 263-0043, Japan
Chiba, Kisarazu, 292-8535, Japan
Chiba, Matsudo, 271-0077, Japan
Fukui, Fukui, 918-8503, Japan
Fukuoka, Chikushino, 818-8502, Japan
Fukuoka, Chikushino, 818-8516, Japan
Fukuoka, Fukuoka, 810-0001, Japan
Fukuoka, Fukuoka, 810-8563, Japan
Fukuoka, Fukuoka, 812-8582, Japan
Fukuoka, Iizuka, 820-8505, Japan
Fukuoka, Kitakyushu, 805-8508, Japan
Fukuoka, Kitakyushu, 806-8501, Japan
Gifu, Ogaki, 503-8502, Japan
Gifu, Seki, 501-3802, Japan
Hiroshima, Fukuyama, 721-8511, Japan
Hiroshima, Hatsukaichi, 738-8503, Japan
Hiroshima, Shobara, 727-0013, Japan
Hyogo, Amagasaki, 660-8550, Japan
Hyogo, Himeji, 670-0981, Japan
Hyogo, Kobe, 654-0155, Japan
Ishikawa, Kanazawa, 920-8650, Japan
Kagawa, Kanonji, 769-1695, Japan
Kagawa, Takamatsu, 760-8557, Japan
Kanagawa, Sagamihara, 252-0311, Japan
Kanagawa, Yokohama, 236-0051, Japan
Kumamoto, Kumamoto, 861-8520, Japan
Kumamoto, Kumamoto, 862-0950, Japan
Kumamoto, Yatsushiro, 866-8533, Japan
Kyoto, Uji, 611-0041, Japan
Miyagi, Sendai, 980-0873, Japan
Miyagi, Sendai, 981-3131, Japan
Miyagi, Sendai, 981-3133, Japan
Miyagi, Sendai, 983-8520, Japan
Miyazaki, Miyazaki, 880-0834, Japan
Nagano, Nakano, 383-8505, Japan
Nagasaki, Omura, 856-8562, Japan
Okayama, Okayama, 700-8557, Japan
Okinawa, Naha, 902-8511, Japan
Okinawa, Urasoe, 901-2132, Japan
Osaka, Higashiosaka, 578-8588, Japan
Osaka, Osaka, 530-8480, Japan
Osaka, Osaka, 533-0024, Japan
Osaka, Sakai, 599-8247, Japan
Osaka, Takatsuki, 569-8585, Japan
Saitama, Saitama, 338-0837, Japan
Saitama, Saitama, 339-0033, Japan
Shiga, Kusatsu, 525-8585, Japan
Tokushima, Tokushima, 770-8539, Japan
Tokyo, Ome, 198-0042, Japan
Tokyo, Ota-ku, 143-0013, Japan
Wakayama, Tanabe, 646-8558, Japan
Yamaguchi, Shimonoseki, 752-8510, Japan
Sungnam, 463-707, South Korea