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 Preserved Ejection Fraction (HFpEF)
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 Preserved Ejection Fraction (HFpEF)
This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction.
Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine.
Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.
Inclusion criteria:
Exclusion criteria:
Chapel Hill, North Carolina 27599-5021, United States
CABA, C1119ACN, Argentina
CABA, C1199ABB, Argentina
Ciudad Autonoma Buenos Aires, C1428ART, Argentina
Ciudad Autonoma Buenos Aires, C1430CKE, Argentina
Ciudad Autonoma de Bs As, C1120AAC, Argentina
Ciudad Autonoma de BuenosAires, C1425AGC, Argentina
Ciudad Autónoma de Bs As, C1180AAX, Argentina
Caxias do Sul, 95070-560, Brazil
Longeuil, Quebec J4M 2X1, Canada
Bogota D.C, 111611, Colombia
Praha 4 - Krc, 140 59, Czechia
Aichi, Kasugai, 486-8510, Japan
Aichi, Nagoya, 466-8650, 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, Kitakyushu, 805-8508, Japan
Fukuoka, Kitakyushu, 806-8501, Japan
Fukushima, Shirakawa, 961-0005, Japan
Gifu, Ogaki, 503-8502, Japan
Gifu, Seki, 501-3802, Japan
Hiroshima, Fukuyama, 721-8511, Japan
Hiroshima, Shobara, 727-0013, Japan
Hyogo, Amagasaki, 660-8550, Japan
Hyogo, Himeji, 670-0981, Japan
Hyogo, Kobe, 654-0155, Japan
Ibaraki, Koga, 306-0041, Japan
Ishikawa, Kanazawa, 920-8650, Japan
Kagawa, Kanonji, 769-1695, Japan
Kagawa, Takamatsu, 760-8557, Japan
Kanagawa, Kawasaki, 212-0021, 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, 983-8520, Japan
Miyazaki, Miyazaki, 880-2102, Japan
Nagano, Nakano, 383-8505, Japan
Nagasaki, Omura, 856-8562, Japan
Oita, Oita, 870-0263, 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, Takatsuki, 569-8585, Japan
Saitama, Saitama, 338-0837, Japan
Saitama, Saitama, 339-0033, 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