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 oktober 2013 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
1639
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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, 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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Rosario, Santa Fe, Argentina, S2000DSV
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Tucuman
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San Miguel de Tucuman, Tucuman, Argentina, T4000JCU
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Antwerpen, Belgien, 2020
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Brasschaat, Belgien, 2930
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Genk, Belgien, 3600
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Gent, Belgien, 9000
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Hasselt, Belgien, 3500
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Huy, Belgien, 4500
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Leuven, Belgien, 3000
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Mechelen, Belgien, 2800
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Mol, Belgien, 2400
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Namur, Belgien, 5000
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MG
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Belo Horizonte, MG, Brasilien, 30150-221
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Belo Horizonte, MG, Brasilien, 20180-090
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Belo Horizonte, MG, Brasilien
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Londrina, PR, Brasilien, 86051-990
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Rio de Janeiro, RJ, Brasilien, 22261-010
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RS
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Porto Alegre, RS, Brasilien, 90610-000
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SP
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Campinas, SP, Brasilien, 13060-904
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Sao Jose do Rio Preto, SP, Brasilien, 15150-210
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São Paulo, SP, Brasilien, 05403-000
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Barranquilla, Colombia
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Bogotá, Colombia, 0000
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29403
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 57701
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Tennessee
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Springfield, Tennessee, Förenta staterna, 37172
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Texas
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Brownsville, Texas, Förenta staterna, 78520
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
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Richmond, Virginia, Förenta staterna, 23249
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Bangalore, Indien, 560 034
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Hyderabad, Indien, 500 063
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New Delhi, Indien, 110 025
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Andhra Pradesh
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Secunderabad, Andhra Pradesh, Indien, 500003
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Gujrat
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Vadodara, Gujrat, Indien, 390015
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Karnataka
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Bangalore, Karnataka, Indien, 560099
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Bangalore, Karnataka, Indien, 560 069
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Mangalore, Karnataka, Indien, 575002
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Kerala
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Kochi, Kerala, Indien, 682 026
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M.p.
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Indore, M.p., Indien, 452001
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Maharashtra
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Mumbai, Maharashtra, Indien, 400 022
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Nagpur, Maharashtra, Indien, 440010
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Nagpur, Maharashtra, Indien, 440012
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Pune, Maharashtra, Indien, 411004
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Pune, Maharashtra, Indien, 411011
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Pune, Maharashtra, Indien, 411030
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Tamil Nadu
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Coimbatore, Tamil Nadu, Indien, 641014
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Ashkelon, Israel, 78278
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(pv)
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Pavia, (pv), Italien, 27100
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(vr)
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Verona, (vr), Italien, 37126
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Bologna, BO, Italien, 40138
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BS
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CR
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Cremona, CR, Italien, 26100
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FE
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Lagosanto, FE, Italien, 44023
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FG
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Foggia, FG, Italien, 71100
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FI
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Firenze, FI, Italien, 50141
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GR
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Grosseto, GR, Italien, 58100
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IS
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Pozzilli, IS, Italien, 86077
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LE
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Casarano, LE, Italien, 73042
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Lecce, LE, Italien, 73100
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Scorrano, LE, Italien, 73020
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Monza, MB, Italien, 20900
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Legnano, MI, Italien, 20025
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Palermo, PA, Italien, 90146
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Perugia, PG, Italien, 06129
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Parma, PR, Italien, 43100
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Albano Laziale, RM, Italien, 00041
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Rimini, RN, Italien, 47900
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Legnago, VR, Italien, 37045
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Grodzisk Wielkopolski, Polen, 62-065
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Kraków, Polen, 31-531
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Moscow, Ryska Federationen, 111539
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Moscow, Ryska Federationen, 115487
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Moscow, Ryska Federationen, 109377
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Saint Petersburg, Ryska Federationen, 195067
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Saint-Petersburg, Ryska Federationen, 198013
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Saratov, Ryska Federationen, 410012
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- Novartis Investigative Site
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Berlin, Tyskland, 13353
- Novartis Investigative Site
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Berlin, Tyskland, 13347
- Novartis Investigative Site
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Berlin, Tyskland, 13578
- Novartis Investigative Site
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Berlin, Tyskland, 12621
- Novartis Investigative Site
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Bischofswerda, Tyskland, 01877
- Novartis Investigative Site
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Bonn, Tyskland, 53105
- Novartis Investigative Site
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Bremen, Tyskland, 28277
- Novartis Investigative Site
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Cloppenburg, Tyskland, 49661
- Novartis Investigative Site
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Cottbus, Tyskland, 03048
- Novartis Investigative Site
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Dessau, Tyskland, D-06822
- Novartis Investigative Site
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Detmold, Tyskland, 32756
- Novartis Investigative Site
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Dortmund, Tyskland, 44137
- Novartis Investigative Site
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Dresden, Tyskland, 01067
- Novartis Investigative Site
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Frankfurt, Tyskland, 60316
- Novartis Investigative Site
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Frankfurt, Tyskland, 60488
- Novartis Investigative Site
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Greifswald, Tyskland, 17475
- Novartis Investigative Site
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Halle/'Saale, Tyskland, 06120
- Novartis Investigative Site
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Hamburg, Tyskland, 20246
- Novartis Investigative Site
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Herne, Tyskland, 44649
- Novartis Investigative Site
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Herrsching, Tyskland, 82211
- Novartis Investigative Site
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Jena, Tyskland, 07740
- Novartis Investigative Site
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Konstanz, Tyskland, 78464
- Novartis Investigative Site
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Köln, Tyskland, 50924
- Novartis Investigative Site
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Langen, Tyskland, 63225
- Novartis Investigative Site
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Ludwigslust, Tyskland, 19288
- Novartis Investigative Site
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Magdeburg, Tyskland, 39120
- Novartis Investigative Site
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Merseburg, Tyskland, 06217
- Novartis Investigative Site
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Muenchen, Tyskland, 81377
- Novartis Investigative Site
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Nordhorn, Tyskland, 48527
- Novartis Investigative Site
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Paderborn, Tyskland, 33098
- Novartis Investigative Site
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Quedlinburg, Tyskland, 06484
- Novartis Investigative Site
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Regensburg, Tyskland, 93053
- Novartis Investigative Site
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Rostock, Tyskland, 18057
- Novartis Investigative Site
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Sömmerda, Tyskland, 99610
- Novartis Investigative Site
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Weiden, Tyskland, 92637
- Novartis Investigative Site
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Balatonfured, Ungern, H-8231
- Novartis Investigative Site
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Budapest, Ungern, 1027
- Novartis Investigative Site
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Budapest, Ungern, 1096
- Novartis Investigative Site
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Budapest, Ungern, H-1106
- Novartis Investigative Site
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Hodmezovasarhely, Ungern, 6800
- Novartis Investigative Site
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Nagykanizsa, Ungern, 8800
- Novartis Investigative Site
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Szolnok, Ungern, H-5000
- Novartis Investigative Site
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Zalaegerszeg, Ungern, 8900
- Novartis Investigative Site
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Baranya
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Pecs, Baranya, Ungern, 7621
- Novartis Investigative Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Aliskiren 150 mg and Aliskiren 300 mg
Andra namn:
|
|
Placebo-jämförare: 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.
|
Placebo
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2009
Primärt slutförande (Faktisk)
1 augusti 2012
Avslutad studie (Faktisk)
1 augusti 2012
Studieregistreringsdatum
Först inskickad
5 maj 2009
Först inskickad som uppfyllde QC-kriterierna
5 maj 2009
Första postat (Uppskatta)
7 maj 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
7 november 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 oktober 2013
Senast verifierad
1 oktober 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CSPP100A2368
- 2009-010236-18 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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