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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 outubro de 2013 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

1639

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Augsburg, Alemanha, 86156
        • Novartis Investigative Site
      • Bad Bevensen, Alemanha, 29549
        • Novartis Investigative Site
      • Bad Nauheim, Alemanha, 61231
        • Novartis Investigative Site
      • Berlin, Alemanha, 10249
        • Novartis Investigative Site
      • Berlin, Alemanha, 10098
        • Novartis Investigative Site
      • Berlin, Alemanha, 13353
        • Novartis Investigative Site
      • Berlin, Alemanha, 13347
        • Novartis Investigative Site
      • Berlin, Alemanha, 13578
        • Novartis Investigative Site
      • Berlin, Alemanha, 12621
        • Novartis Investigative Site
      • Bischofswerda, Alemanha, 01877
        • Novartis Investigative Site
      • Bonn, Alemanha, 53105
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      • Bremen, Alemanha, 28277
        • Novartis Investigative Site
      • Cloppenburg, Alemanha, 49661
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      • Cottbus, Alemanha, 03048
        • Novartis Investigative Site
      • Dessau, Alemanha, D-06822
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      • Detmold, Alemanha, 32756
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      • Dortmund, Alemanha, 44137
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      • Dresden, Alemanha, 01067
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      • Frankfurt, Alemanha, 60316
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      • Frankfurt, Alemanha, 60488
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      • Greifswald, Alemanha, 17475
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      • Halle/'Saale, Alemanha, 06120
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      • Hamburg, Alemanha, 20246
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      • Herne, Alemanha, 44649
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      • Herrsching, Alemanha, 82211
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      • Jena, Alemanha, 07740
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      • Konstanz, Alemanha, 78464
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      • Köln, Alemanha, 50924
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      • Langen, Alemanha, 63225
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      • Ludwigslust, Alemanha, 19288
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      • Magdeburg, Alemanha, 39120
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      • Merseburg, Alemanha, 06217
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      • Muenchen, Alemanha, 81377
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      • Nordhorn, Alemanha, 48527
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      • Paderborn, Alemanha, 33098
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      • Quedlinburg, Alemanha, 06484
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      • Regensburg, Alemanha, 93053
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      • Rostock, Alemanha, 18057
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      • Sömmerda, Alemanha, 99610
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      • Weiden, Alemanha, 92637
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  • Argentina
      • 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
      • San Nicolas, Buenos Aires, Argentina, B2900IIC
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    • Misiones
      • Posadas, Misiones, Argentina, N3300AHX
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    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSV
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      • Rosario, Santa Fe, Argentina, S2001ODA
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    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000JCU
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  • Brasil
    • MG
      • 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
      • Londrina, PR, Brasil, 86051-990
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    • RJ
      • Rio de Janeiro, RJ, Brasil, 22261-010
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    • RS
      • Porto Alegre, RS, Brasil, 90610-000
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    • SP
      • 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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  • Bélgica
      • 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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  • Canadá
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
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    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 2Y9
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    • Ontario
      • Ottawa, Ontario, Canadá, K1Y 4W7
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      • Toronto, Ontario, Canadá, M5B 1W8
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    • Quebec
      • Montreal, Quebec, Canadá, H3T 1E2
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      • Montreal, Quebec, Canadá, H3A 1A1
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  • Cingapura
      • Singapore, Cingapura, 119074
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      • Singapore, Cingapura, 168752
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      • Singapore, Cingapura, 768825
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  • Colômbia
      • Barranquilla, Colômbia
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      • Bogotá, Colômbia, 0000
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      • Cali, Colômbia
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      • Florida Blanca, Colômbia
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    • Atlantico
      • Barranquilla, Atlantico, Colômbia
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    • Cundinamarca
      • Bogotá, Cundinamarca, Colômbia
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  • Eslováquia
      • Bratislava, Eslováquia, 833 48
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      • Bratislava, Eslováquia, 813 69
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      • Komarno, Eslováquia, 94575
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      • Kosice, Eslováquia, 040 01
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      • Kosice-Saca, Eslováquia, 040 01
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      • Levice, Eslováquia, 934 01
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      • Lucenec, Eslováquia, 984 39
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      • Martin, Eslováquia, 036 59
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      • Nitra, Eslováquia, 949 01
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      • Trnava, Eslováquia, 917 75
        • Novartis Investigative Site
    • Slovak Republic
      • Liptovsky Mikulas, Slovak Republic, Eslováquia, 831 23
        • Novartis Investigative Site
      • Presov, Slovak Republic, Eslováquia, 081 81
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  • Espanha
      • Madrid, Espanha, 28046
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      • Madrid, Espanha, 28007
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      • Madrid, Espanha, 28040
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    • Andalucia
      • Sanlúcar de Barrameda, Andalucia, Espanha, 11540
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      • Villamartin, Andalucia, Espanha, 11650
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    • Baleares
      • Palma de Mallorca, Baleares, Espanha, 07010
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    • Cataluña
      • Barcelona, Cataluña, Espanha, 08003
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    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Espanha, 46014
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    • Galicia
      • Santiago de Compostela, Galicia, Espanha, 15706
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    • Madrid
      • Majadanonda, Madrid, Espanha, 28220
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      • Pozuelo de Alarcón, Madrid, Espanha, 28223
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  • Estados Unidos
    • Alabama
      • Mobile, Alabama, Estados Unidos, 36608
        • Novartis Investigative Site
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85723-0001
        • Novartis Investigative Site
    • California
      • 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
      • Hartford, Connecticut, Estados Unidos, 06102-5037
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    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20037
        • Novartis Investigative Site
      • Washington, District of Columbia, Estados Unidos, 20010-2975
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    • Florida
      • Jacksonville, Florida, Estados Unidos, 32207
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    • Georgia
      • Macon, Georgia, Estados Unidos, 31201
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    • Illinois
      • Oakbrook Terrace, Illinois, Estados Unidos, 60181
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    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52245
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    • Louisiana
      • Lafayette, Louisiana, Estados Unidos, 70501
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    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
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      • Kalamazoo, Michigan, Estados Unidos, 49048
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, Estados Unidos, 63110
        • Novartis Investigative Site
    • New Jersey
      • Cherry Hill, New Jersey, Estados Unidos, 08034
        • Novartis Investigative Site
      • Newark, New Jersey, Estados Unidos, 07103-2714
        • Novartis Investigative Site
    • New York
      • Bronx, New York, Estados Unidos, 10461
        • Novartis Investigative Site
      • Buffalo, New York, Estados Unidos, 14215
        • Novartis Investigative Site
      • Buffalo, New York, Estados Unidos, 14203
        • Novartis Investigative Site
      • Saratoga Springs, New York, Estados Unidos, 12866
        • Novartis Investigative Site
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599-7075
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
        • Novartis Investigative Site
      • Cincinnati, Ohio, Estados Unidos, 45267-0585
        • Novartis Investigative Site
      • Cleveland, Ohio, Estados Unidos, 44109-1998
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19140
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Estados Unidos, 19102-1192
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29403
        • Novartis Investigative Site
    • South Dakota
      • Rapid City, South Dakota, Estados Unidos, 57701
        • Novartis Investigative Site
    • Tennessee
      • Springfield, Tennessee, Estados Unidos, 37172
        • Novartis Investigative Site
    • Texas
      • Brownsville, Texas, Estados Unidos, 78520
        • Novartis Investigative Site
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
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      • Richmond, Virginia, Estados Unidos, 23298
        • Novartis Investigative Site
      • Richmond, Virginia, Estados Unidos, 23249
        • Novartis Investigative Site
  • Federação Russa
      • Lubertsi, Federação Russa, 140006
        • Novartis Investigative Site
      • Moscow, Federação Russa, 117198
        • Novartis Investigative Site
      • Moscow, Federação Russa, 127473
        • Novartis Investigative Site
      • Moscow, Federação Russa, 127644
        • Novartis Investigative Site
      • Moscow, Federação Russa, 121552
        • Novartis Investigative Site
      • Moscow, Federação Russa, 119881
        • Novartis Investigative Site
      • Moscow, Federação Russa, 111539
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      • Moscow, Federação Russa, 115487
        • Novartis Investigative Site
      • Moscow, Federação Russa, 109377
        • Novartis Investigative Site
      • Nizhnii Novgorod, Federação Russa, 603000
        • Novartis Investigative Site
      • S.-Petersburg, Federação Russa, 196247
        • Novartis Investigative Site
      • S.-Petersburg, Federação Russa, 192242
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      • S.-Petersburg, Federação Russa, 198205
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      • S.-Petersburg, Federação Russa, 195197
        • Novartis Investigative Site
      • Saint Petersburg, Federação Russa, 199106
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      • Saint Petersburg, Federação Russa, 195067
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      • Saint-Petersburg, Federação Russa, 197341
        • Novartis Investigative Site
      • Saint-Petersburg, Federação Russa, 193312
        • Novartis Investigative Site
      • Saint-Petersburg, Federação Russa, 198013
        • Novartis Investigative Site
      • Sankt-Peterburg, Federação Russa, 197022
        • Novartis Investigative Site
      • Saratov, Federação Russa, 410028
        • Novartis Investigative Site
      • Saratov, Federação Russa, 410012
        • Novartis Investigative Site
      • St.Petersburg, Federação Russa, 193163
        • Novartis Investigative Site
      • Yaroslavl, Federação Russa, 150003
        • Novartis Investigative Site
  • Filipinas
      • Manila, Filipinas, 1000
        • Novartis Investigative Site
      • Quezon City, Filipinas, 1100
        • Novartis Investigative Site
    • Metro Manila
      • Quezon City, Metro Manila, Filipinas, 1109
        • Novartis Investigative Site
  • Finlândia
      • Jyvaskyla, Finlândia, FIN-40620
        • Novartis Investigative Site
      • Turku, Finlândia, 20520
        • Novartis Investigative Site
  • França
      • Bordeaux Cedex, França, 33075
        • Novartis Investigative Site
      • Grenoble, França, 38043
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      • Le Chesnay, França
        • Novartis Investigative Site
      • Paris, França, 75013
        • Novartis Investigative Site
      • Paris, França, 75571
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      • Pessac Cedex, França, 33604
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      • Pontoise, França, F-95300
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      • Toulouse Cedex, França, 31059
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  • Hungria
      • Balatonfured, Hungria, H-8231
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      • Budapest, Hungria, 1027
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      • Budapest, Hungria, 1096
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      • Budapest, Hungria, H-1106
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      • Hodmezovasarhely, Hungria, 6800
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      • Nagykanizsa, Hungria, 8800
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      • Szolnok, Hungria, H-5000
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      • Zalaegerszeg, Hungria, 8900
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    • Baranya
      • Pecs, Baranya, Hungria, 7621
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  • Israel
      • 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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  • Itália
    • (pv)
      • Pavia, (pv), Itália, 27100
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    • (vr)
      • Verona, (vr), Itália, 37126
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    • BO
      • Bologna, BO, Itália, 40138
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    • BS
      • Brescia, BS, Itália, 25123
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    • CR
      • Cremona, CR, Itália, 26100
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    • CT
      • Catania, CT, Itália, 95123
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    • FE
      • Lagosanto, FE, Itália, 44023
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    • FG
      • Foggia, FG, Itália, 71100
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    • FI
      • Firenze, FI, Itália, 50141
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    • GR
      • Grosseto, GR, Itália, 58100
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    • IS
      • Pozzilli, IS, Itália, 86077
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    • LE
      • Casarano, LE, Itália, 73042
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      • Lecce, LE, Itália, 73100
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      • Scorrano, LE, Itália, 73020
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    • MB
      • Monza, MB, Itália, 20900
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    • MI
      • Legnano, MI, Itália, 20025
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      • Milano, MI, Itália, 20157
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    • PA
      • Palermo, PA, Itália, 90146
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    • PG
      • Perugia, PG, Itália, 06129
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    • PR
      • Parma, PR, Itália, 43100
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    • RM
      • Albano Laziale, RM, Itália, 00041
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      • Roma, RM, Itália, 00185
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      • Roma, RM, Itália, 00189
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    • RN
      • Rimini, RN, Itália, 47900
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    • SI
      • Siena, SI, Itália, 53100
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    • VR
      • Legnago, VR, Itália, 37045
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  • Peru
      • Ankara, Peru, 06500
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      • Atakum / Samsun, Peru, 55139
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      • Etlik / Ankara, Peru, 06018
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      • Istanbul, Peru, 34303
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      • Istanbul, Peru, 34304
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      • Izmir, Peru, 35040
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      • Izmir, Peru, 35340
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      • Kirikkale, Peru, 71100
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      • Kocaeli, Peru, 41380
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      • Sivas, Peru, 58140
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      • Talas / Kayseri, Peru, 38039
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  • Polônia
      • Grodzisk Wielkopolski, Polônia, 62-065
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      • Klodzko, Polônia, 57-300
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      • Kraków, Polônia, 31-531
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      • Lublin, Polônia, 20-954
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      • Warszawa, Polônia, 04-628
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      • Warszawa, Polônia, 03-242
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      • Wroclaw, Polônia, 50-367
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      • Wroclaw, Polônia, 50-981
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      • Zabrze, Polônia, 41-800
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      • Zamosc, Polônia, 22-400
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  • República Checa
      • 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
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      • Prague 5, República Checa, 150 00
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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
      • Hradec Kralove, CZE, República Checa, 500 05
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  • Romênia
      • Bucharest, Romênia, 021659
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      • Bucharest, Romênia, 020125
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      • Craiova, Romênia, 200642
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      • Timisoara, Romênia, 300310
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      • Tirgoviste, Romênia, 130083
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    • District 1
      • Bucuresti, District 1, Romênia, 014461
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  • Suécia
      • Göteborg, Suécia, 416 85
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      • Stockholm, Suécia, 141 86
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      • Stockholm, Suécia, 118 83
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      • Stockholm, Suécia, 182 88
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  • Taiwan
      • Kaohsiung, Taiwan, 807
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      • Keelung City, Taiwan, 20401
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      • Lin-Ko, Taiwan, 33305
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      • Taichung, Taiwan, 40447
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      • Taipei, Taiwan
        • Novartis Investigative Site
      • Taipei, Taiwan, 112
        • Novartis Investigative Site
  • Índia
      • Bangalore, Índia, 560 034
        • Novartis Investigative Site
      • Hyderabad, Índia, 500 063
        • Novartis Investigative Site
      • New Delhi, Índia, 110 025
        • Novartis Investigative Site
    • Andhra Pradesh
      • Secunderabad, Andhra Pradesh, Índia, 500003
        • Novartis Investigative Site
    • Gujrat
      • Vadodara, Gujrat, Índia, 390015
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, Índia, 560099
        • Novartis Investigative Site
      • Bangalore, Karnataka, Índia, 560 069
        • Novartis Investigative Site
      • Mangalore, Karnataka, Índia, 575002
        • Novartis Investigative Site
    • Kerala
      • Kochi, Kerala, Índia, 682 026
        • Novartis Investigative Site
    • M.p.
      • Indore, M.p., Índia, 452001
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, Índia, 400 022
        • Novartis Investigative Site
      • Nagpur, Maharashtra, Índia, 440010
        • Novartis Investigative Site
      • Nagpur, Maharashtra, Índia, 440012
        • Novartis Investigative Site
      • Pune, Maharashtra, Índia, 411004
        • Novartis Investigative Site
      • Pune, Maharashtra, Índia, 411011
        • Novartis Investigative Site
      • Pune, Maharashtra, Índia, 411030
        • Novartis Investigative Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, Índia, 641014
        • Novartis Investigative Site
      • Coimbatore, Tamil Nadu, Índia, 641037
        • Novartis Investigative Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: Aliskiren
Aliskiren 150 mg and Aliskiren 300 mg
Outros nomes:
  • SPP100
  • Aliskiren®,
  • Tekturna®,
  • Rasilez®,
Comparador de Placebo: 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.
Medicamento: Placebo
Placebo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 6 months
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.
6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 12 months
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.
12 months
Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months
Prazo: Baseline, 1 months, 6 months and 12 months
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.
Baseline, 1 months, 6 months and 12 months
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Prazo: 6 months
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
6 months
Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months
Prazo: 12 months
12 months
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
Prazo: Baseline, 1 month, 6 months and 12 months
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.
Baseline, 1 month, 6 months and 12 months
Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months
Prazo: 12 months
A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.
12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de maio de 2009

Conclusão Primária (Real)

1 de agosto de 2012

Conclusão do estudo (Real)

1 de agosto de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

5 de maio de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de maio de 2009

Primeira postagem (Estimativa)

7 de maio de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

7 de novembro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de outubro de 2013

Última verificação

1 de outubro de 2013

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CSPP100A2368
  • 2009-010236-18 (Número EudraCT)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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