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)

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.

Study Overview

• Status: Completed
• Conditions: Acute Decompensated Heart Failure; Congestive Heart Failure
• Intervention / Treatment: Drug: Placebo; Drug: Aliskiren

• Study Type: Interventional
• Enrollment (Actual): 1639
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1050AAK
    • Novartis Investigative Site
  • Buenos Aires, Argentina, W3400ABH
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1094AAD
    • Novartis Investigative Site
  • Buenos Aires, Argentina, B1650CSQ
    • Novartis Investigative Site
  • Buenos Aires, Argentina, B1708KCH
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1201AAO
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1428AQK
    • Novartis Investigative Site
  • Buenos aires, Argentina, C1210AAP
    • Novartis Investigative Site
  • Cordoba, Argentina, X5006IKK
    • Novartis Investigative Site
  • Cordoba, Argentina, X5000AAI
    • Novartis Investigative Site
  • Corrientes, Argentina, 3400
    • Novartis Investigative Site
  • Corrientes, Argentina, W3400
    • Novartis Investigative Site
  • Corrientes, Argentina, W3400CBI
    • Novartis Investigative Site
  • Quilmes, Argentina, 1878
    • Novartis Investigative Site
  • Santa Fe, Argentina, 3000
    • Novartis Investigative Site
  • Santa Fe, Argentina, S2004CMW
    • Novartis Investigative Site
  • Tucuman, Argentina, T4000NIJ
    • Novartis Investigative Site
  • Buenos Aires
    • San Nicolas, Buenos Aires, Argentina, B2900IIC
      • Novartis Investigative Site
  • Misiones
    • Posadas, Misiones, Argentina, N3300AHX
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DSV
      • Novartis Investigative Site
    • Rosario, Santa Fe, Argentina, S2001ODA
      • Novartis Investigative Site
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, T4000JCU
      • Novartis Investigative Site
• Belgium
  • Antwerpen, Belgium, 2020
    • Novartis Investigative Site
  • Brasschaat, Belgium, 2930
    • Novartis Investigative Site
  • Genk, Belgium, 3600
    • Novartis Investigative Site
  • Gent, Belgium, 9000
    • Novartis Investigative Site
  • Hasselt, Belgium, 3500
    • Novartis Investigative Site
  • Huy, Belgium, 4500
    • Novartis Investigative Site
  • Leuven, Belgium, 3000
    • Novartis Investigative Site
  • Mechelen, Belgium, 2800
    • Novartis Investigative Site
  • Mol, Belgium, 2400
    • Novartis Investigative Site
  • Namur, Belgium, 5000
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• Brazil
  • MG
    • Belo Horizonte, MG, Brazil, 30150-221
      • Novartis Investigative Site
    • Belo Horizonte, MG, Brazil, 20180-090
      • Novartis Investigative Site
    • Belo Horizonte, MG, Brazil
      • Novartis Investigative Site
  • PR
    • Londrina, PR, Brazil, 86051-990
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  • RJ
    • Rio de Janeiro, RJ, Brazil, 22261-010
      • Novartis Investigative Site
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
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  • SP
    • Campinas, SP, Brazil, 13060-904
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    • Sao Jose do Rio Preto, SP, Brazil, 15150-210
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    • São Paulo, SP, Brazil, 05403-000
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• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
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  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
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  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
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    • Toronto, Ontario, Canada, M5B 1W8
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  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
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    • Montreal, Quebec, Canada, H3A 1A1
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• Colombia
  • 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
    • Barranquilla, Atlantico, Colombia
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  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia
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• Czech Republic
  • Brno, Czech Republic, 636 00
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  • Brno - Bohunice, Czech Republic, 625 00
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  • Olomouc, Czech Republic, 775 20
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  • Prague 4, Czech Republic, 146 24
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  • Prague 5, Czech Republic, 150 00
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  • Praha 10, Czech Republic, 100 34
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  • Praha 2, Czech Republic, 128 08
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  • Slany, Czech Republic, 27401
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  • Teplice, Czech Republic, 415 29
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  • Znojmo, Czech Republic, 669 02
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  • CZE
    • Hradec Kralove, CZE, Czech Republic, 500 05
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• Finland
  • Jyvaskyla, Finland, FIN-40620
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  • Turku, Finland, 20520
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• France
  • Bordeaux Cedex, France, 33075
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  • Grenoble, France, 38043
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  • Le Chesnay, France
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  • Paris, France, 75013
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  • Paris, France, 75571
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  • Pessac Cedex, France, 33604
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  • Pontoise, France, F-95300
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  • Toulouse Cedex, France, 31059
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• Germany
  • Augsburg, Germany, 86156
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  • Bad Bevensen, Germany, 29549
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  • Bad Nauheim, Germany, 61231
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  • Berlin, Germany, 10249
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  • Berlin, Germany, 10098
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  • Berlin, Germany, 13353
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  • Berlin, Germany, 13347
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  • Berlin, Germany, 13578
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  • Berlin, Germany, 12621
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  • Bischofswerda, Germany, 01877
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  • Bonn, Germany, 53105
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  • Bremen, Germany, 28277
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  • Cloppenburg, Germany, 49661
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  • Cottbus, Germany, 03048
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  • Dessau, Germany, D-06822
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  • Detmold, Germany, 32756
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  • Dortmund, Germany, 44137
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  • Dresden, Germany, 01067
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  • Frankfurt, Germany, 60316
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  • Frankfurt, Germany, 60488
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  • Greifswald, Germany, 17475
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  • Halle/'Saale, Germany, 06120
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  • Hamburg, Germany, 20246
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  • Herne, Germany, 44649
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  • Herrsching, Germany, 82211
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  • Jena, Germany, 07740
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  • Konstanz, Germany, 78464
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  • Köln, Germany, 50924
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  • Langen, Germany, 63225
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  • Ludwigslust, Germany, 19288
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  • Magdeburg, Germany, 39120
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  • Merseburg, Germany, 06217
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  • Muenchen, Germany, 81377
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  • Nordhorn, Germany, 48527
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  • Paderborn, Germany, 33098
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  • Quedlinburg, Germany, 06484
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  • Regensburg, Germany, 93053
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  • Rostock, Germany, 18057
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  • Sömmerda, Germany, 99610
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  • Weiden, Germany, 92637
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• Hungary
  • Balatonfured, Hungary, H-8231
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  • Budapest, Hungary, 1027
    • Novartis Investigative Site
  • Budapest, Hungary, 1096
    • Novartis Investigative Site
  • Budapest, Hungary, H-1106
    • Novartis Investigative Site
  • Hodmezovasarhely, Hungary, 6800
    • Novartis Investigative Site
  • Nagykanizsa, Hungary, 8800
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  • Szolnok, Hungary, H-5000
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  • Zalaegerszeg, Hungary, 8900
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  • Baranya
    • Pecs, Baranya, Hungary, 7621
      • Novartis Investigative Site
• India
  • Bangalore, India, 560 034
    • Novartis Investigative Site
  • Hyderabad, India, 500 063
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  • New Delhi, India, 110 025
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  • Andhra Pradesh
    • Secunderabad, Andhra Pradesh, India, 500003
      • Novartis Investigative Site
  • Gujrat
    • Vadodara, Gujrat, India, 390015
      • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Novartis Investigative Site
    • Bangalore, Karnataka, India, 560 069
      • Novartis Investigative Site
    • Mangalore, Karnataka, India, 575002
      • Novartis Investigative Site
  • Kerala
    • Kochi, Kerala, India, 682 026
      • Novartis Investigative Site
  • M.p.
    • Indore, M.p., India, 452001
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  • Maharashtra
    • Mumbai, Maharashtra, India, 400 022
      • Novartis Investigative Site
    • Nagpur, Maharashtra, India, 440010
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    • Nagpur, Maharashtra, India, 440012
      • Novartis Investigative Site
    • 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
    • Coimbatore, Tamil Nadu, India, 641014
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    • Coimbatore, Tamil Nadu, India, 641037
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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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• Italy
  • (pv)
    • Pavia, (pv), Italy, 27100
      • Novartis Investigative Site
  • (vr)
    • Verona, (vr), Italy, 37126
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  • BO
    • Bologna, BO, Italy, 40138
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  • BS
    • Brescia, BS, Italy, 25123
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  • CR
    • Cremona, CR, Italy, 26100
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  • CT
    • Catania, CT, Italy, 95123
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  • FE
    • Lagosanto, FE, Italy, 44023
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  • FG
    • Foggia, FG, Italy, 71100
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  • FI
    • Firenze, FI, Italy, 50141
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  • GR
    • Grosseto, GR, Italy, 58100
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  • IS
    • Pozzilli, IS, Italy, 86077
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  • LE
    • Casarano, LE, Italy, 73042
      • Novartis Investigative Site
    • Lecce, LE, Italy, 73100
      • Novartis Investigative Site
    • Scorrano, LE, Italy, 73020
      • Novartis Investigative Site
  • MB
    • Monza, MB, Italy, 20900
      • Novartis Investigative Site
  • MI
    • Legnano, MI, Italy, 20025
      • Novartis Investigative Site
    • Milano, MI, Italy, 20157
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  • PA
    • Palermo, PA, Italy, 90146
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  • PG
    • Perugia, PG, Italy, 06129
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  • PR
    • Parma, PR, Italy, 43100
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  • RM
    • Albano Laziale, RM, Italy, 00041
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    • Roma, RM, Italy, 00185
      • Novartis Investigative Site
    • Roma, RM, Italy, 00189
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  • RN
    • Rimini, RN, Italy, 47900
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  • SI
    • Siena, SI, Italy, 53100
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  • VR
    • Legnago, VR, Italy, 37045
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• Philippines
  • Manila, Philippines, 1000
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  • Quezon City, Philippines, 1100
    • Novartis Investigative Site
  • Metro Manila
    • Quezon City, Metro Manila, Philippines, 1109
      • Novartis Investigative Site
• Poland
  • Grodzisk Wielkopolski, Poland, 62-065
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  • Klodzko, Poland, 57-300
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  • Kraków, Poland, 31-531
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  • Lublin, Poland, 20-954
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  • Lódz, Poland, 91-347
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  • Ruda Slaska, Poland, 41-703
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  • Swidnica, Poland, 58-100
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  • Szczecin, Poland, 70-111
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  • Walbrzych, Poland, 58-309
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  • Warszawa, Poland, 04-628
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  • Warszawa, Poland, 03-242
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  • Wroclaw, Poland, 50-367
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  • Wroclaw, Poland, 50-981
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  • Zabrze, Poland, 41-800
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  • Zamosc, Poland, 22-400
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• Romania
  • Bucharest, Romania, 021659
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  • Bucharest, Romania, 020125
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  • Craiova, Romania, 200642
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  • Timisoara, Romania, 300310
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  • Tirgoviste, Romania, 130083
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  • District 1
    • Bucuresti, District 1, Romania, 014461
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• Russian Federation
  • Lubertsi, Russian Federation, 140006
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  • Moscow, Russian Federation, 117198
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  • Moscow, Russian Federation, 127473
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  • Moscow, Russian Federation, 127644
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  • Moscow, Russian Federation, 121552
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  • Moscow, Russian Federation, 119881
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  • Moscow, Russian Federation, 111539
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  • Moscow, Russian Federation, 115487
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  • Moscow, Russian Federation, 109377
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  • Nizhnii Novgorod, Russian Federation, 603000
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  • S.-Petersburg, Russian Federation, 196247
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  • S.-Petersburg, Russian Federation, 192242
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  • S.-Petersburg, Russian Federation, 198205
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  • S.-Petersburg, Russian Federation, 195197
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  • Saint Petersburg, Russian Federation, 199106
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  • Saint Petersburg, Russian Federation, 195067
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  • Saint-Petersburg, Russian Federation, 197341
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  • Saint-Petersburg, Russian Federation, 193312
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  • Saint-Petersburg, Russian Federation, 198013
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  • Sankt-Peterburg, Russian Federation, 197022
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  • Saratov, Russian Federation, 410028
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  • Saratov, Russian Federation, 410012
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  • St.Petersburg, Russian Federation, 193163
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  • Yaroslavl, Russian Federation, 150003
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• Singapore
  • Singapore, Singapore, 119074
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  • Singapore, Singapore, 168752
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  • Singapore, Singapore, 768825
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• Slovakia
  • Bratislava, Slovakia, 833 48
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  • Bratislava, Slovakia, 813 69
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  • Komarno, Slovakia, 94575
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  • Kosice, Slovakia, 040 01
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  • Kosice-Saca, Slovakia, 040 01
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  • Levice, Slovakia, 934 01
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  • Lucenec, Slovakia, 984 39
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  • Martin, Slovakia, 036 59
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  • Nitra, Slovakia, 949 01
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  • Trnava, Slovakia, 917 75
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  • Slovak Republic
    • Liptovsky Mikulas, Slovak Republic, Slovakia, 831 23
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    • Presov, Slovak Republic, Slovakia, 081 81
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• Spain
  • Madrid, Spain, 28046
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  • Madrid, Spain, 28007
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  • Madrid, Spain, 28040
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  • Andalucia
    • Sanlúcar de Barrameda, Andalucia, Spain, 11540
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    • Villamartin, Andalucia, Spain, 11650
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  • Baleares
    • Palma de Mallorca, Baleares, Spain, 07010
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  • Cataluña
    • Barcelona, Cataluña, Spain, 08003
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  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46014
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  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
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  • Madrid
    • Majadanonda, Madrid, Spain, 28220
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    • Pozuelo de Alarcón, Madrid, Spain, 28223
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• Sweden
  • Göteborg, Sweden, 416 85
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  • Stockholm, Sweden, 141 86
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  • Stockholm, Sweden, 118 83
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  • Stockholm, Sweden, 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
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  • Taipei, Taiwan, 112
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• Turkey
  • Ankara, Turkey, 06500
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  • Atakum / Samsun, Turkey, 55139
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  • Etlik / Ankara, Turkey, 06018
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  • Istanbul, Turkey, 34303
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  • Istanbul, Turkey, 34304
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  • Izmir, Turkey, 35040
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  • Izmir, Turkey, 35340
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  • Kirikkale, Turkey, 71100
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  • Kocaeli, Turkey, 41380
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  • Sivas, Turkey, 58140
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  • Talas / Kayseri, Turkey, 38039
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• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
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  • Arizona
    • Tucson, Arizona, United States, 85723-0001
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  • California
    • Los Angeles, California, United States, 90073
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    • San Diego, California, United States, 92103
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    • Sylmar, California, United States, 91342
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    • Torrance, California, United States, 90502
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  • Connecticut
    • Hartford, Connecticut, United States, 06102-5037
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  • District of Columbia
    • Washington, District of Columbia, United States, 20037
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    • Washington, District of Columbia, United States, 20010-2975
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  • Florida
    • Jacksonville, Florida, United States, 32207
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  • Georgia
    • Macon, Georgia, United States, 31201
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  • Illinois
    • Oakbrook Terrace, Illinois, United States, 60181
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  • Iowa
    • Iowa City, Iowa, United States, 52245
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  • Louisiana
    • Lafayette, Louisiana, United States, 70501
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  • Michigan
    • Detroit, Michigan, United States, 48202
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    • Kalamazoo, Michigan, United States, 49048
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  • Missouri
    • St. Louis, Missouri, United States, 63110
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  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
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    • Newark, New Jersey, United States, 07103-2714
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  • New York
    • Bronx, New York, United States, 10461
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    • Buffalo, New York, United States, 14215
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    • Buffalo, New York, United States, 14203
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    • Saratoga Springs, New York, United States, 12866
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  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7075
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  • Ohio
    • Cincinnati, Ohio, United States, 45219
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    • Cincinnati, Ohio, United States, 45267-0585
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    • Cleveland, Ohio, United States, 44109-1998
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  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
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    • Philadelphia, Pennsylvania, United States, 19102-1192
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    • Pittsburgh, Pennsylvania, United States, 15212
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  • South Carolina
    • Charleston, South Carolina, United States, 29403
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  • South Dakota
    • Rapid City, South Dakota, United States, 57701
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  • Tennessee
    • Springfield, Tennessee, United States, 37172
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  • Texas
    • Brownsville, Texas, United States, 78520
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  • Virginia
    • Charlottesville, Virginia, United States, 22908
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    • Richmond, Virginia, United States, 23298
      • Novartis Investigative Site
    • Richmond, Virginia, United States, 23249
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Aliskiren; Aliskiren 150 mg and Aliskiren 300 mg; Other Names: SPP100; Aliskiren®,; Tekturna®,; Rasilez®,
Placebo Comparator: 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.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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		12 months
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 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	A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.	12 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: May 5, 2009
• First Submitted That Met QC Criteria: May 5, 2009
• First Posted (Estimate): May 7, 2009

Study Record Updates

• Last Update Posted (Estimate): November 7, 2013
• Last Update Submitted That Met QC Criteria: October 15, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: CHF; hospitalization; Acute Heart Failure; eGFR; BNP; plasma renin activity; direct renin inhibitors; Cardiovascular death; KCCQ; outcome study; renin angiotensin; morbi-mortality trial; endpoint driven; elevated BNP; reduced LVEF; aldosterone system
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CSPP100A2368; 2009-010236-18 (EudraCT Number)