Recruitment

Recruitment Status
Completed
Estimated Enrollment
470

Inclusion Criterias

Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization
Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization
Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization

Exclusion Criterias

Intravenous inotropes at any time after hospitalization
Intravenous inotropes at any time after hospitalization

Summary

Conditions
Heart Failure
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization
Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
Left ventricular ejection fraction (LVEF) >/= 45% by echocardiography at randomization
Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization

Exclusion Criterias

Intravenous inotropes at any time after hospitalization
Intravenous inotropes at any time after hospitalization

Locations

Mechelen, 2800
Fort Lauderdale, Florida, 33308
Rouen, 76031
Naha, Okinawa, 902-8511
Tokushima, 770-8539
...
Mechelen, 2800
Fort Lauderdale, Florida, 33308
Rouen, 76031
Naha, Okinawa, 902-8511
Tokushima, 770-8539
Iizuka, Fukuoka, 820-8505
Gilly, 6060
Minato-ku, Tokyo, 106-0031
Valencia, 46026
Graz, Steiermark, 8036
Lisboa, 1449-005
New Orleans, Louisiana, 70112-1396
Poznan, 61-848
Wien, 1220
MOL, 2400
Roeselare, 8800
Milwaukee, Wisconsin, 53215
Karlstad, 652 30
Taoyuan, 333423
Praha 2, 12808
Kromeriz, 767 01
Praha 6, 169 02
Singapore, 119228
Helsingborg, 251 87
Bruxelles - Brussel, 1200
Bad Krozingen, Baden-Württemberg, 79189
Bad Homburg, Hessen, 61348
Fukui, 910-8526
Jackson, Mississippi, 39216-4505
New Taipei City, 220
Holbaek, 4300
Singapore, 169609
Burgas, 8018
Sofia, 1309
Majadahonda, Madrid, 28222
Montreal, Quebec, H2W 1T8
Linz, Oberösterreich, 4010
Minneapolis, Minnesota, 55422
Nashville, Tennessee, 37232-8802
Higashiibaraki, Ibaraki, 311-3193
Stara Zagora, 6000
Sneek, 8601 ZR
Praha 4, 140 21
Petah Tikva, 4941492
Ancona, Marche, 60126
Amsterdam, 1105 AZ
Tel Aviv, 6423906
Toronto, Ontario, M5B 1W8
Singapore, 308433
Fountain Valley, California, 92708
Praha 10, 10034
Erfurt, Thüringen, 99089
Linz, Oberösterreich, 4020
Hadera, 3810101
Santander, Cantabria, 39008
Saint-Jean-sur-Richelieu, Quebec, J3A 1C3
Uji, Kyoto, 611-0041
Brisbane, Queensland, 4064
Germantown, Tennessee, 38138
El Palmar, Murcia, 30120
Örebro, 701 85
München, Bayern, 80331
Randers, 8930
Nagasaki, 850-8555
Linköping, 581 85
Macon, Georgia, 31201
Genève, 1205
Takatsuki, Osaka, 569-1096
Iowa City, Iowa, 52242
Barcelona, 08023
Chaidari, 12462
Tiberias, 1528001
Kaohsiung, 813
Chesterfield, Derbyshire, S44 5DX
Valencia, 46010
Almada, 2801-951
Leeuwarden, 8934 AD
Sherbrooke, Quebec, J1G 2E8
Takamatsu, Kagawa, 760-0018
Yokohama, Kanagawa, 236-0051
Nea Ionia / Athens, 142 33
Budapest, 1097
Yokosuka, Kanagawa, 238-8567
Darlinghurst, New South Wales, 2010
St. Pölten, Niederösterreich, 3100
Lisboa, 1649-035
Pittsburgh, Pennsylvania, 15212
Bialystok, 15-276
Sofia, 1202
Redcliffe, Queensland, 4020
Wien, 1090
Gent, 9000
Hamburg, 20246
Singapore, 768828
Stevenage, Hertfordshire, SG1 4AB
Sofia, 1233
Hiroshima, 734-8530
Seoul, 138-736
Lugano, Ticino, 6900
Charleston, South Carolina, 29425
Detroit, Michigan, 48202
Kumamoto, 862-8505
Toulouse, 31403
Zrifin, 7030000
Brescia, Lombardia, 25123
Newark, New Jersey, 07103
Komatsushima, Tokushima, 773-8502
Kanazawa, Ishikawa, 920-8650
Osaka, 558-8558
Heerenveen, 8441 PW
Taipei, 11217
Salzburg, 5020
Taipei, 10016
Milano, Lombardia, 20149
Bergamo, Lombardia, 24127
Homburg, Saarland, 66421
Sofia, 1527
Lodz, 93-513
Krakow, 31-202
Naples, Florida, 34102
Meguro-ku, Tokyo, 152-8902
Köln, Nordrhein-Westfalen, 50937
Ashkelon, 7830604
Barcelona, 08003
Quebec, G1V 4G5
Sagamihara, Kanagawa, 252-5188
Brisbane, Queensland, 4029
Pessac, 33604
Aalborg, 9000
Brugge, 8000
Olsztyn, 10-010
Himeji, Hyogo, 670-0981
Milano, Lombardia, 20017
Chicago, Illinois, 60611-2908
Hannover, Niedersachsen, 30625
Lodz, 92-213
Arezzo, Toscana, 52040
Lisboa, 1500-650
Rehovot, 7610001
Toyama, 930-8550
Afula, 1834111
Greifswald, Mecklenburg-Vorpommern, 17475
Stockholm, 118 83
Athens, 11527
Kistarcsa, H-2143
Sakai, Osaka, 599-8247
Buffalo, New York, 14215
Szczecin, 70-965
Münster, Nordrhein-Westfalen, 48149
HUY, 4500
Pavia, Lombardia, 27100
Montreal, Quebec, H1T 1C8
Jerusalem, 9103102
Haifa, 3109601
BRON Cedex, 69677
Krakow, 31-121
Szekesfehervar, 8000
Hobart, Tasmania, 7000

Tracking Information

NCT #
NCT01951638
Collaborators
Not Provided
Investigators
Study Director: Bayer Study Director Bayer