Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure (ASTRONAUT)
15 de octubre de 2013 actualizado por: Novartis Pharmaceuticals
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the 6 Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality When Initiated Early After Hospitalization for Acute Decompensated Heart Failure
This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1639
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Augsburg, Alemania, 86156
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Bad Bevensen, Alemania, 29549
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Bad Nauheim, Alemania, 61231
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Berlin, Alemania, 10249
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Berlin, Alemania, 10098
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Berlin, Alemania, 13353
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Berlin, Alemania, 13347
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Berlin, Alemania, 13578
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Berlin, Alemania, 12621
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Bischofswerda, Alemania, 01877
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Bonn, Alemania, 53105
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Bremen, Alemania, 28277
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Cloppenburg, Alemania, 49661
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Cottbus, Alemania, 03048
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Dessau, Alemania, D-06822
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Detmold, Alemania, 32756
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Dortmund, Alemania, 44137
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Dresden, Alemania, 01067
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Frankfurt, Alemania, 60316
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Frankfurt, Alemania, 60488
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Greifswald, Alemania, 17475
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Halle/'Saale, Alemania, 06120
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Hamburg, Alemania, 20246
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Herne, Alemania, 44649
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Herrsching, Alemania, 82211
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Jena, Alemania, 07740
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Konstanz, Alemania, 78464
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Köln, Alemania, 50924
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Langen, Alemania, 63225
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Ludwigslust, Alemania, 19288
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Magdeburg, Alemania, 39120
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Merseburg, Alemania, 06217
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Muenchen, Alemania, 81377
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Nordhorn, Alemania, 48527
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Paderborn, Alemania, 33098
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Quedlinburg, Alemania, 06484
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Regensburg, Alemania, 93053
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Rostock, Alemania, 18057
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Sömmerda, Alemania, 99610
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Weiden, Alemania, 92637
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Buenos Aires, Argentina
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Buenos Aires, Argentina, C1050AAK
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Buenos Aires, Argentina, W3400ABH
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Buenos Aires, Argentina, C1094AAD
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Buenos Aires, Argentina, B1650CSQ
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Buenos Aires, Argentina, B1708KCH
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Buenos Aires, Argentina, C1201AAO
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Buenos Aires, Argentina, C1428AQK
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Buenos aires, Argentina, C1210AAP
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Cordoba, Argentina, X5006IKK
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Cordoba, Argentina, X5000AAI
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Corrientes, Argentina, 3400
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Corrientes, Argentina, W3400
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Corrientes, Argentina, W3400CBI
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Quilmes, Argentina, 1878
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Santa Fe, Argentina, 3000
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Santa Fe, Argentina, S2004CMW
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Tucuman, Argentina, T4000NIJ
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Buenos Aires
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San Nicolas, Buenos Aires, Argentina, B2900IIC
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Misiones
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Posadas, Misiones, Argentina, N3300AHX
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DSV
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Rosario, Santa Fe, Argentina, S2001ODA
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Tucuman
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San Miguel de Tucuman, Tucuman, Argentina, T4000JCU
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MG
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Belo Horizonte, MG, Brasil, 30150-221
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Belo Horizonte, MG, Brasil, 20180-090
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Belo Horizonte, MG, Brasil
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PR
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Londrina, PR, Brasil, 86051-990
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RJ
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Rio de Janeiro, RJ, Brasil, 22261-010
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RS
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Porto Alegre, RS, Brasil, 90610-000
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SP
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Campinas, SP, Brasil, 13060-904
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Sao Jose do Rio Preto, SP, Brasil, 15150-210
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São Paulo, SP, Brasil, 05403-000
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Antwerpen, Bélgica, 2020
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Brasschaat, Bélgica, 2930
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Genk, Bélgica, 3600
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Gent, Bélgica, 9000
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Hasselt, Bélgica, 3500
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Huy, Bélgica, 4500
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Leuven, Bélgica, 3000
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Mechelen, Bélgica, 2800
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Mol, Bélgica, 2400
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Namur, Bélgica, 5000
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 2Y9
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Ontario
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Ottawa, Ontario, Canadá, K1Y 4W7
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Toronto, Ontario, Canadá, M5B 1W8
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Quebec
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Montreal, Quebec, Canadá, H3T 1E2
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Montreal, Quebec, Canadá, H3A 1A1
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Barranquilla, Colombia
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Bogotá, Colombia
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Bogotá, Colombia, 0000
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Cali, Colombia
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Florida Blanca, Colombia
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Atlantico
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Barranquilla, Atlantico, Colombia
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Cundinamarca
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Bogotá, Cundinamarca, Colombia
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Bratislava, Eslovaquia, 833 48
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Bratislava, Eslovaquia, 813 69
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Komarno, Eslovaquia, 94575
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Kosice, Eslovaquia, 040 01
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Kosice-Saca, Eslovaquia, 040 01
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Levice, Eslovaquia, 934 01
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Lucenec, Eslovaquia, 984 39
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Martin, Eslovaquia, 036 59
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Nitra, Eslovaquia, 949 01
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Trnava, Eslovaquia, 917 75
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Slovak Republic
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Liptovsky Mikulas, Slovak Republic, Eslovaquia, 831 23
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Presov, Slovak Republic, Eslovaquia, 081 81
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Madrid, España, 28046
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Madrid, España, 28007
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Madrid, España, 28040
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Andalucia
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Sanlúcar de Barrameda, Andalucia, España, 11540
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Villamartin, Andalucia, España, 11650
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Baleares
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Palma de Mallorca, Baleares, España, 07010
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Cataluña
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Barcelona, Cataluña, España, 08003
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, España, 46014
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Galicia
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Santiago de Compostela, Galicia, España, 15706
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Madrid
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Majadanonda, Madrid, España, 28220
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Pozuelo de Alarcón, Madrid, España, 28223
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Alabama
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Mobile, Alabama, Estados Unidos, 36608
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Arizona
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Tucson, Arizona, Estados Unidos, 85723-0001
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California
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Los Angeles, California, Estados Unidos, 90073
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San Diego, California, Estados Unidos, 92103
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Sylmar, California, Estados Unidos, 91342
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Torrance, California, Estados Unidos, 90502
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06102-5037
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20037
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Washington, District of Columbia, Estados Unidos, 20010-2975
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Florida
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Jacksonville, Florida, Estados Unidos, 32207
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Georgia
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Macon, Georgia, Estados Unidos, 31201
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Illinois
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Oakbrook Terrace, Illinois, Estados Unidos, 60181
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Iowa
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Iowa City, Iowa, Estados Unidos, 52245
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Louisiana
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Lafayette, Louisiana, Estados Unidos, 70501
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
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Kalamazoo, Michigan, Estados Unidos, 49048
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
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New Jersey
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Cherry Hill, New Jersey, Estados Unidos, 08034
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Newark, New Jersey, Estados Unidos, 07103-2714
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New York
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Bronx, New York, Estados Unidos, 10461
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Buffalo, New York, Estados Unidos, 14215
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Buffalo, New York, Estados Unidos, 14203
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Saratoga Springs, New York, Estados Unidos, 12866
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7075
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
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Cincinnati, Ohio, Estados Unidos, 45267-0585
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Cleveland, Ohio, Estados Unidos, 44109-1998
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19140
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Philadelphia, Pennsylvania, Estados Unidos, 19102-1192
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Pittsburgh, Pennsylvania, Estados Unidos, 15212
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29403
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57701
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Tennessee
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Springfield, Tennessee, Estados Unidos, 37172
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Texas
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Brownsville, Texas, Estados Unidos, 78520
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
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Richmond, Virginia, Estados Unidos, 23298
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Richmond, Virginia, Estados Unidos, 23249
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Lubertsi, Federación Rusa, 140006
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Moscow, Federación Rusa, 117198
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Moscow, Federación Rusa, 127473
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Moscow, Federación Rusa, 127644
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Moscow, Federación Rusa, 121552
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Moscow, Federación Rusa, 119881
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Moscow, Federación Rusa, 111539
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Moscow, Federación Rusa, 115487
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Moscow, Federación Rusa, 109377
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Nizhnii Novgorod, Federación Rusa, 603000
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S.-Petersburg, Federación Rusa, 196247
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S.-Petersburg, Federación Rusa, 192242
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S.-Petersburg, Federación Rusa, 198205
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S.-Petersburg, Federación Rusa, 195197
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Saint Petersburg, Federación Rusa, 199106
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Saint Petersburg, Federación Rusa, 195067
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Saint-Petersburg, Federación Rusa, 197341
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Saint-Petersburg, Federación Rusa, 193312
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Saint-Petersburg, Federación Rusa, 198013
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Sankt-Peterburg, Federación Rusa, 197022
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Saratov, Federación Rusa, 410028
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Saratov, Federación Rusa, 410012
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St.Petersburg, Federación Rusa, 193163
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Yaroslavl, Federación Rusa, 150003
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Manila, Filipinas, 1000
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Quezon City, Filipinas, 1100
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Metro Manila
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Quezon City, Metro Manila, Filipinas, 1109
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Jyvaskyla, Finlandia, FIN-40620
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Turku, Finlandia, 20520
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Bordeaux Cedex, Francia, 33075
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Grenoble, Francia, 38043
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Le Chesnay, Francia
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Paris, Francia, 75013
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Paris, Francia, 75571
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Pessac Cedex, Francia, 33604
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Pontoise, Francia, F-95300
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Toulouse Cedex, Francia, 31059
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Balatonfured, Hungría, H-8231
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Budapest, Hungría, 1027
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Budapest, Hungría, 1096
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Budapest, Hungría, H-1106
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Hodmezovasarhely, Hungría, 6800
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Nagykanizsa, Hungría, 8800
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Szolnok, Hungría, H-5000
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Zalaegerszeg, Hungría, 8900
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Baranya
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Pecs, Baranya, Hungría, 7621
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Bangalore, India, 560 034
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Hyderabad, India, 500 063
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New Delhi, India, 110 025
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Andhra Pradesh
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Secunderabad, Andhra Pradesh, India, 500003
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Gujrat
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Vadodara, Gujrat, India, 390015
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Karnataka
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Bangalore, Karnataka, India, 560099
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Bangalore, Karnataka, India, 560 069
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Mangalore, Karnataka, India, 575002
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Kerala
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Kochi, Kerala, India, 682 026
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M.p.
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Indore, M.p., India, 452001
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Maharashtra
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Mumbai, Maharashtra, India, 400 022
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Nagpur, Maharashtra, India, 440010
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Nagpur, Maharashtra, India, 440012
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Pune, Maharashtra, India, 411004
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Pune, Maharashtra, India, 411011
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Pune, Maharashtra, India, 411030
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Tamil Nadu
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Coimbatore, Tamil Nadu, India, 641014
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Coimbatore, Tamil Nadu, India, 641037
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Ashkelon, Israel, 78278
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Hadera, Israel, 38100
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Haifa, Israel, 34362
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Jerusalem, Israel, 91120
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Nazareth, Israel, 16100
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Safed, Israel, 13100
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Tel-Aviv, Israel, 64239
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(pv)
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Pavia, (pv), Italia, 27100
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(vr)
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Verona, (vr), Italia, 37126
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Bologna, BO, Italia, 40138
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BS
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Brescia, BS, Italia, 25123
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CR
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Cremona, CR, Italia, 26100
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CT
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Catania, CT, Italia, 95123
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FE
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Lagosanto, FE, Italia, 44023
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FG
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Foggia, FG, Italia, 71100
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FI
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Firenze, FI, Italia, 50141
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GR
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Grosseto, GR, Italia, 58100
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IS
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Pozzilli, IS, Italia, 86077
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LE
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Casarano, LE, Italia, 73042
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Lecce, LE, Italia, 73100
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Scorrano, LE, Italia, 73020
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Monza, MB, Italia, 20900
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MI
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Legnano, MI, Italia, 20025
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Milano, MI, Italia, 20157
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PA
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Palermo, PA, Italia, 90146
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PG
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Perugia, PG, Italia, 06129
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Parma, PR, Italia, 43100
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RM
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Albano Laziale, RM, Italia, 00041
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Roma, RM, Italia, 00185
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Roma, RM, Italia, 00189
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RN
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Rimini, RN, Italia, 47900
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SI
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Siena, SI, Italia, 53100
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VR
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Legnago, VR, Italia, 37045
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Ankara, Pavo, 06500
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Atakum / Samsun, Pavo, 55139
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Etlik / Ankara, Pavo, 06018
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Istanbul, Pavo, 34303
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Istanbul, Pavo, 34304
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Izmir, Pavo, 35040
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Izmir, Pavo, 35340
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Kirikkale, Pavo, 71100
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Kocaeli, Pavo, 41380
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Sivas, Pavo, 58140
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Talas / Kayseri, Pavo, 38039
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Grodzisk Wielkopolski, Polonia, 62-065
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Kraków, Polonia, 31-531
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Lódz, Polonia, 91-347
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Ruda Slaska, Polonia, 41-703
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Swidnica, Polonia, 58-100
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Szczecin, Polonia, 70-111
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Walbrzych, Polonia, 58-309
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Warszawa, Polonia, 04-628
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Warszawa, Polonia, 03-242
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Wroclaw, Polonia, 50-367
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Wroclaw, Polonia, 50-981
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Zabrze, Polonia, 41-800
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Zamosc, Polonia, 22-400
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Brno, República Checa, 636 00
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Brno - Bohunice, República Checa, 625 00
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Olomouc, República Checa, 775 20
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Prague 4, República Checa, 146 24
- Novartis Investigative Site
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Prague 5, República Checa, 150 00
- Novartis Investigative Site
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Praha 10, República Checa, 100 34
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Praha 2, República Checa, 128 08
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Slany, República Checa, 27401
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Teplice, República Checa, 415 29
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Znojmo, República Checa, 669 02
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CZE
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Hradec Kralove, CZE, República Checa, 500 05
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Bucharest, Rumania, 021659
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Bucharest, Rumania, 020125
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Craiova, Rumania, 200642
- Novartis Investigative Site
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Timisoara, Rumania, 300310
- Novartis Investigative Site
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Tirgoviste, Rumania, 130083
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District 1
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Bucuresti, District 1, Rumania, 014461
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Singapore, Singapur, 119074
- Novartis Investigative Site
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Singapore, Singapur, 168752
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Singapore, Singapur, 768825
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Göteborg, Suecia, 416 85
- Novartis Investigative Site
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Stockholm, Suecia, 141 86
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Stockholm, Suecia, 118 83
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Stockholm, Suecia, 182 88
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Kaohsiung, Taiwán, 807
- Novartis Investigative Site
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Keelung City, Taiwán, 20401
- Novartis Investigative Site
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Lin-Ko, Taiwán, 33305
- Novartis Investigative Site
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Taichung, Taiwán, 40447
- Novartis Investigative Site
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Taipei, Taiwán
- Novartis Investigative Site
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Taipei, Taiwán, 112
- Novartis Investigative Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion criteria:
- Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female.
Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization.
- LVEF < 40% (measured within the last 6 months).
- Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization.
- Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml).
- Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).
Exclusion Criteria:
- Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
- Concomitant use of ACEI and ARB at randomization.
- Right heart failure due to pulmonary disease.
- Diagnosis of postpartum cardiomyopathy.
- Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
- Patients with a history of heart transplant or who are on a transplant list.
- Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.
Other protocol-defined inclusion/exclusion criteria applied.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Aliskiren
Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks.
From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
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Aliskiren 150 mg and Aliskiren 300 mg
Otros nombres:
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Comparador de placebos: Placebo
Randomized patients in this arm received matching placebo of Aliskiren.
At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
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Placebo
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months
Periodo de tiempo: 6 months
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Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable.
For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization).
The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months
Periodo de tiempo: 12 months
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Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable.
For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization).
The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.
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12 months
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Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months
Periodo de tiempo: Baseline, 1 months, 6 months and 12 months
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Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ).
The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction.
Each scale score was calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning.
A score of 100 represents perfect health whereas a score of 0 represents death.
A positive change in score from baseline indicates an improvement.
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Baseline, 1 months, 6 months and 12 months
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Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Periodo de tiempo: 6 months
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A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
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6 months
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Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months
Periodo de tiempo: 12 months
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12 months
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Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
Periodo de tiempo: Baseline, 1 month, 6 months and 12 months
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The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.
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Baseline, 1 month, 6 months and 12 months
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Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Periodo de tiempo: 12 months
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A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
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12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Vaduganathan M, Cheema B, Cleveland E, Sankar K, Subacius H, Fonarow GC, Solomon SD, Lewis EF, Greene SJ, Maggioni AP, Bohm M, Zannad F, Butler J, Gheorghiade M. Plasma renin activity, response to aliskiren, and clinical outcomes in patients hospitalized for heart failure: the ASTRONAUT trial. Eur J Heart Fail. 2018 Apr;20(4):677-686. doi: 10.1002/ejhf.973. Epub 2017 Nov 16.
- Greene SJ, Butler J, Fonarow GC, Subacius HP, Ambrosy AP, Vaduganathan M, Triggiani M, Solomon SD, Lewis EF, Maggioni AP, Bohm M, Chioncel O, Nodari S, Senni M, Zannad F, Gheorghiade M; ASTRONAUT Investigators and Coordinators. Pre-discharge and early post-discharge troponin elevation among patients hospitalized for heart failure with reduced ejection fraction: findings from the ASTRONAUT trial. Eur J Heart Fail. 2018 Feb;20(2):281-291. doi: 10.1002/ejhf.1019. Epub 2017 Oct 17.
- Lund LH, Trochu JN, Meyns B, Caliskan K, Shaw S, Schmitto JD, Schibilsky D, Damme L, Heatley J, Gustafsson F. Screening for heart transplantation and left ventricular assist system: results from the ScrEEning for advanced Heart Failure treatment (SEE-HF) study. Eur J Heart Fail. 2018 Jan;20(1):152-160. doi: 10.1002/ejhf.975. Epub 2017 Sep 27.
- Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954. Erratum In: JAMA. 2013 Apr 10;309(14):1461.
- Gheorghiade M, Albaghdadi M, Zannad F, Fonarow GC, Bohm M, Gimpelewicz C, Botha J, Moores S, Lewis EF, Rattunde H, Maggioni A; ASTRONAUT investigators and study coordinators. Rationale and design of the multicentre, randomized, double-blind, placebo-controlled Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT). Eur J Heart Fail. 2011 Jan;13(1):100-6. doi: 10.1093/eurjhf/hfq209. Epub 2010 Nov 30.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2009
Finalización primaria (Actual)
1 de agosto de 2012
Finalización del estudio (Actual)
1 de agosto de 2012
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2009
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2009
Publicado por primera vez (Estimar)
7 de mayo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de noviembre de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
15 de octubre de 2013
Última verificación
1 de octubre de 2013
Más información
Términos relacionados con este estudio
Palabras clave
- Francos suizos
- hospitalización
- Insuficiencia cardiaca aguda
- eGFR
- BNP
- actividad de la renina plasmática
- inhibidores directos de renina
- Muerte cardiovascular
- KCCQ
- estudio de resultados
- renina angiotensina
- ensayo de morbi-mortalidad
- impulsado por el punto final
- elevated BNP
- reduced LVEF
- aldosterone system
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CSPP100A2368
- 2009-010236-18 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .