AzTrials
AzTrials

Acute Decompensated Heart FailurePhase 3ASTRONAUTNCT00894387

Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

A Phase 3 study testing Aliskiren in people with Acute Decompensated Heart Failure and Congestive Heart Failure, run by Novartis Pharmaceuticals at 308 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aliskiren
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,639 participants
Where
308 sitesin 24 countries
Study dates
May 2009to Aug 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

308 sites in 24 countries.

308 sites in 24 countries

Germany40 sites

  • Novartis Investigative Site

    Augsburg, 86156

  • Novartis Investigative Site

    Bad Bevensen, 29549

  • Novartis Investigative Site

    Bad Nauheim, 61231

  • Novartis Investigative Site

    Berlin, 10098

  • Novartis Investigative Site

    Berlin, 10249

  • Novartis Investigative Site

    Berlin, 12621

  • Novartis Investigative Site

    Berlin, 13347

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 13578

  • Novartis Investigative Site

    Bischofswerda, 01877

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Bremen, 28277

  • Novartis Investigative Site

    Cloppenburg, 49661

  • Novartis Investigative Site

    Cologne, 50924

  • Novartis Investigative Site

    Cottbus, 03048

  • Novartis Investigative Site

    Dessau, D-06822

  • Novartis Investigative Site

    Detmold, 32756

  • Novartis Investigative Site

    Dortmund, 44137

  • Novartis Investigative Site

    Dresden, 01067

  • Novartis Investigative Site

    Frankfurt, 60316

  • Novartis Investigative Site

    Frankfurt, 60488

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Halle, 06120

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Herrsching am Ammersee, 82211

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Konstanz, 78464

  • Novartis Investigative Site

    Langen, 63225

  • Novartis Investigative Site

    Ludwigslust, 19288

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Merseburg, 06217

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    Nordhorn, 48527

  • Novartis Investigative Site

    Paderborn, 33098

  • Novartis Investigative Site

    Quedlinburg, 06484

  • Novartis Investigative Site

    Regensburg, 93053

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Sömmerda, 99610

  • Novartis Investigative Site

    Weiden, 92637

Other trials in Germany

United States37 sites

  • Novartis Investigative Site

    Brownsville, Texas, 78520

  • Novartis Investigative Site

    Buffalo, New York, 14203

  • Novartis Investigative Site

    Buffalo, New York, 14215

  • Novartis Investigative Site

    Chapel Hill, North Carolina, 27599-7075

  • Novartis Investigative Site

    Charleston, South Carolina, 29403

  • Novartis Investigative Site

    Charlottesville, Virginia, 22908

  • Novartis Investigative Site

    Cherry Hill, New Jersey, 08034

  • Novartis Investigative Site

    Cincinnati, Ohio, 45219

  • Novartis Investigative Site

    Cincinnati, Ohio, 45267-0585

  • Novartis Investigative Site

    Cleveland, Ohio, 44109-1998

  • Novartis Investigative Site

    Detroit, Michigan, 48202

  • Novartis Investigative Site

    Hartford, Connecticut, 06102-5037

  • Novartis Investigative Site

    Iowa City, Iowa, 52245

  • Novartis Investigative Site

    Jacksonville, Florida, 32207

  • Novartis Investigative Site

    Kalamazoo, Michigan, 49048

  • Novartis Investigative Site

    Lafayette, Louisiana, 70501

  • Novartis Investigative Site

    Los Angeles, California, 90073

  • Novartis Investigative Site

    Macon, Georgia, 31201

  • Novartis Investigative Site

    Mobile, Alabama, 36608

  • Novartis Investigative Site

    Newark, New Jersey, 07103-2714

  • Novartis Investigative Site

    Oakbrook Terrace, Illinois, 60181

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19102-1192

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19140

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15212

  • Novartis Investigative Site

    Rapid City, South Dakota, 57701

  • Novartis Investigative Site

    Richmond, Virginia, 23249

  • Novartis Investigative Site

    Richmond, Virginia, 23298

  • Novartis Investigative Site

    San Diego, California, 92103

  • Novartis Investigative Site

    Saratoga Springs, New York, 12866

  • Novartis Investigative Site

    Springfield, Tennessee, 37172

  • Novartis Investigative Site

    St Louis, Missouri, 63110

  • Novartis Investigative Site

    Sylmar, California, 91342

  • Novartis Investigative Site

    The Bronx, New York, 10461

  • Novartis Investigative Site

    Torrance, California, 90502

  • Novartis Investigative Site

    Tucson, Arizona, 85723-0001

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20010-2975

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20037

Other trials in United States

Italy26 sites

  • Novartis Investigative Site

    Albano Laziale, RM, 00041

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Casarano, LE, 73042

  • Novartis Investigative Site

    Catania, CT, 95123

  • Novartis Investigative Site

    Cremona, CR, 26100

  • Novartis Investigative Site

    Florence, FI, 50141

  • Novartis Investigative Site

    Foggia, FG, 71100

  • Novartis Investigative Site

    Grosseto, GR, 58100

  • Novartis Investigative Site

    Lagosanto, FE, 44023

  • Novartis Investigative Site

    Lecce, LE, 73100

  • Novartis Investigative Site

    Legnago, VR, 37045

  • Novartis Investigative Site

    Legnano, MI, 20025

  • Novartis Investigative Site

    Milan, MI, 20157

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Pavia, (pv), 27100

  • Novartis Investigative Site

    Perugia, PG, 06129

  • Novartis Investigative Site

    Pozzilli, IS, 86077

  • Novartis Investigative Site

    Rimini, RN, 47900

  • Novartis Investigative Site

    Roma, RM, 00185

  • Novartis Investigative Site

    Roma, RM, 00189

  • Novartis Investigative Site

    Scorrano, LE, 73020

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Verona, (vr), 37126

Other trials in Italy

Russia24 sites

  • Novartis Investigative Site

    Lyubertsy, 140006

  • Novartis Investigative Site

    Moscow, 109377

  • Novartis Investigative Site

    Moscow, 111539

  • Novartis Investigative Site

    Moscow, 115487

  • Novartis Investigative Site

    Moscow, 117198

  • Novartis Investigative Site

    Moscow, 119881

  • Novartis Investigative Site

    Moscow, 121552

  • Novartis Investigative Site

    Moscow, 127473

  • Novartis Investigative Site

    Moscow, 127644

  • Novartis Investigative Site

    Nizhny Novgorod, 603000

  • Novartis Investigative Site

    S.-Petersburg, 192242

  • Novartis Investigative Site

    S.-Petersburg, 195197

  • Novartis Investigative Site

    S.-Petersburg, 196247

  • Novartis Investigative Site

    S.-Petersburg, 198205

  • Novartis Investigative Site

    Saint Petersburg, 193163

  • Novartis Investigative Site

    Saint Petersburg, 193312

  • Novartis Investigative Site

    Saint Petersburg, 195067

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 197341

  • Novartis Investigative Site

    Saint Petersburg, 198013

  • Novartis Investigative Site

    Saint Petersburg, 199106

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Saratov, 410028

  • Novartis Investigative Site

    Yaroslavl, 150003

Other trials in Russia

Argentina23 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, B1650CSQ

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, B1708KCH

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1094AAD

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1201AAO

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1210AAP

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1428AQK

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, W3400ABH

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000AAI

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5006IKK

  • Novartis Investigative Site

    Corrientes, Corrientes Province, 3400

  • Novartis Investigative Site

    Corrientes, Corrientes Province, W3400CBI

  • Novartis Investigative Site

    Corrientes, Corrientes Province, W3400

  • Novartis Investigative Site

    Posadas, Misiones Province, N3300AHX

  • Novartis Investigative Site

    Quilmes, 1878

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DSV

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2001ODA

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000JCU

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000NIJ

  • Novartis Investigative Site

    San Nicolás de los Arroyos, Buenos Aires, B2900IIC

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, 3000

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, S2004CMW

Other trials in Argentina

India18 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560 069

  • Novartis Investigative Site

    Bangalore, Karnataka, 560099

  • Novartis Investigative Site

    Bangalore, 560 034

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641014

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641037

  • Novartis Investigative Site

    Hyderabad, 500 063

  • Novartis Investigative Site

    Indore, M.p., 452001

  • Novartis Investigative Site

    Kochi, Kerala, 682 026

  • Novartis Investigative Site

    Mangalore, Karnataka, 575002

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400 022

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440010

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440012

  • Novartis Investigative Site

    New Delhi, India, 110 025

  • Novartis Investigative Site

    Pune, Maharashtra, 411004

  • Novartis Investigative Site

    Pune, Maharashtra, 411011

  • Novartis Investigative Site

    Pune, Maharashtra, 411030

  • Novartis Investigative Site

    Secunderabad, Andhra Pradesh, 500003

  • Novartis Investigative Site

    Vadodara, Gujarat, 390015

Other trials in India

Poland15 sites

  • Novartis Investigative Site

    Grodzisk Wielkopolski, 62-065

  • Novartis Investigative Site

    Kłodzko, 57-300

  • Novartis Investigative Site

    Krakow, Poland, 31-531

  • Novartis Investigative Site

    Lódz, 91-347

  • Novartis Investigative Site

    Lublin, 20-954

  • Novartis Investigative Site

    Ruda Śląska, 41-703

  • Novartis Investigative Site

    Swidnica, 58-100

  • Novartis Investigative Site

    Szczecin, 70-111

  • Novartis Investigative Site

    Wałbrzych, 58-309

  • Novartis Investigative Site

    Warsaw, 03-242

  • Novartis Investigative Site

    Warsaw, 04-628

  • Novartis Investigative Site

    Wroclaw, 50-367

  • Novartis Investigative Site

    Wroclaw, 50-981

  • Novartis Investigative Site

    Zabrze, 41-800

  • Novartis Investigative Site

    Zamość, 22-400

Other trials in Poland

Slovakia12 sites

  • Novartis Investigative Site

    Bratislava, 813 69

  • Novartis Investigative Site

    Bratislava, 833 48

  • Novartis Investigative Site

    Komárno, Slovakia, 94575

  • Novartis Investigative Site

    Košice, 040 01

  • Novartis Investigative Site

    Kosice-Saca, 040 01

  • Novartis Investigative Site

    Levice, Slovakia, 934 01

  • Novartis Investigative Site

    Liptovský Mikuláš, Slovak Republic, 831 23

  • Novartis Investigative Site

    Lučenec, 984 39

  • Novartis Investigative Site

    Martin, 036 59

  • Novartis Investigative Site

    Nitra, Slovakia, 949 01

  • Novartis Investigative Site

    Prešov, Slovak Republic, 081 81

  • Novartis Investigative Site

    Trnava, Slovakia, 917 75

Other trials in Slovakia

Czechia11 sites

  • Novartis Investigative Site

    Brno, 636 00

  • Novartis Investigative Site

    Brno-Bohunice, Czech Republic, 625 00

  • Novartis Investigative Site

    Hradec Králové, CZE, 500 05

  • Novartis Investigative Site

    Olomouc, 775 20

  • Novartis Investigative Site

    Prague, 100 34

  • Novartis Investigative Site

    Prague, 128 08

  • Novartis Investigative Site

    Prague, 146 24

  • Novartis Investigative Site

    Prague, 150 00

  • Novartis Investigative Site

    Slaný, Czech Republic, 27401

  • Novartis Investigative Site

    Teplice, 415 29

  • Novartis Investigative Site

    Znojmo, Czech Republic, 669 02

Other trials in Czechia

Spain11 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Madrid, Madrid, 28007

  • Novartis Investigative Site

    Madrid, Madrid, 28040

  • Novartis Investigative Site

    Madrid, Madrid, 28046

  • Novartis Investigative Site

    Majadanonda, Madrid, 28220

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands, 07010

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    Sanlúcar de Barrameda, Andalusia, 11540

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Valencia, Valencia, 46014

  • Novartis Investigative Site

    Villamartín, Andalusia, 11650

Other trials in Spain

Turkey (Türkiye)11 sites

  • Novartis Investigative Site

    Ankara, Turkey, 06500

  • Novartis Investigative Site

    Atakum / Samsun, 55139

  • Novartis Investigative Site

    Etlik / Ankara, 06018

  • Novartis Investigative Site

    Istanbul, Turkey, 34304

  • Novartis Investigative Site

    Istanbul, 34303

  • Novartis Investigative Site

    Izmir, 35040

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Kirikkale, 71100

  • Novartis Investigative Site

    Kocaeli, 41380

  • Novartis Investigative Site

    Sivas, 58140

  • Novartis Investigative Site

    Talas / Kayseri, 38039

Other trials in Turkey (Türkiye)

Belgium10 sites

  • Novartis Investigative Site

    Antwerp, 2020

  • Novartis Investigative Site

    Brasschaat, 2930

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Huy, 4500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Mechelen, 2800

  • Novartis Investigative Site

    Mol, 2400

  • Novartis Investigative Site

    Namur, 5000

Other trials in Belgium

Brazil9 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 20180-090

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-221

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais

  • Novartis Investigative Site

    Campinas, São Paulo, 13060-904

  • Novartis Investigative Site

    Londrina, Paraná, 86051-990

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 22261-010

  • Novartis Investigative Site

    São José do Rio Preto, São Paulo, 15150-210

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Hungary9 sites

  • Novartis Investigative Site

    Balatonfüred, H-8231

  • Novartis Investigative Site

    Budapest, 1027

  • Novartis Investigative Site

    Budapest, 1096

  • Novartis Investigative Site

    Budapest, H-1106

  • Novartis Investigative Site

    Hódmezővásárhely, 6800

  • Novartis Investigative Site

    Nagykanizsa, 8800

  • Novartis Investigative Site

    Pécs, Baranya, 7621

  • Novartis Investigative Site

    Szolnok, H-5000

  • Novartis Investigative Site

    Zalaegerszeg, 8900

Other trials in Hungary

France8 sites

  • Novartis Investigative Site

    Bordeaux, 33075

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Le Chesnay

  • Novartis Investigative Site

    Paris, 75013

  • Novartis Investigative Site

    Paris, 75571

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Pontoise, F-95300

  • Novartis Investigative Site

    Toulouse, 31059

Other trials in France

Colombia7 sites

  • Novartis Investigative Site

    Barranquilla, Atlántico

  • Novartis Investigative Site

    Barranquilla

  • Novartis Investigative Site

    Bogotá, Cundinamarca

  • Novartis Investigative Site

    Bogotá, 0000

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigative Site

    Cali

  • Novartis Investigative Site

    Florida Blanca

Other trials in Colombia

Israel7 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Hadera, 38100

  • Novartis Investigative Site

    Haifa, 34362

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Nazareth, Israel, 16100

  • Novartis Investigative Site

    Safed, 13100

  • Novartis Investigative Site

    Tel Aviv, 64239

Other trials in Israel

Canada6 sites

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 2Y9

  • Novartis Investigative Site

    Montreal, Quebec, H3A 1A1

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2

  • Novartis Investigative Site

    Ottawa, Ontario, K1Y 4W7

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Novartis Investigative Site

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Romania6 sites

  • Novartis Investigative Site

    Bucharest, District 1, 014461

  • Novartis Investigative Site

    Bucharest, 020125

  • Novartis Investigative Site

    Bucharest, 021659

  • Novartis Investigative Site

    Craiova, 200642

  • Novartis Investigative Site

    Targoviste, 130083

  • Novartis Investigative Site

    Timișoara, 300310

Other trials in Romania

Taiwan6 sites

  • Novartis Investigative Site

    Kaohsiung City, 807

  • Novartis Investigative Site

    Keelung, 20401

  • Novartis Investigative Site

    Lin-Ko, 33305

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Taipei, Taiwan

  • Novartis Investigative Site

    Taipei, 112

Other trials in Taiwan

Sweden4 sites

  • Novartis Investigative Site

    Gothenburg, 416 85

  • Novartis Investigative Site

    Stockholm, 118 83

  • Novartis Investigative Site

    Stockholm, 141 86

  • Novartis Investigative Site

    Stockholm, 182 88

Other trials in Sweden

Philippines3 sites

  • Novartis Investigative Site

    Manila, 1000

  • Novartis Investigative Site

    Quezon City, National Capital Region, 1109

  • Novartis Investigative Site

    Quezon City, 1100

Other trials in Philippines

Singapore3 sites

  • Novartis Investigative Site

    Singapore, Singapore, 119074

  • Novartis Investigative Site

    Singapore, Singapore, 168752

  • Novartis Investigative Site

    Singapore, Singapore, 768825

Other trials in Singapore

Finland2 sites

  • Novartis Investigative Site

    Jyväskylä, FIN-40620

  • Novartis Investigative Site

    Turku, 20520

Other trials in Finland

About this study

Official title: 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.

Being tested
Aliskiren, Placebo
Keywords
elevated BNP, reduced LVEF, Acute Heart Failure, Cardiovascular death, CHF, hospitalization, morbi-mortality trial, outcome study, endpoint driven, plasma renin activity, renin angiotensin, aldosterone system, direct renin inhibitors, BNP, KCCQ, eGFR
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AliskirenDrug

    Also called Aliskiren®,, Tekturna®,, Rasilez®,, SPP100

    Aliskiren 150 mg and Aliskiren 300 mg

  • PlaceboDrug

    Placebo

Study groups in NCT00894387
Study groupRoleWhat they receive
AliskirenExperimentalRandomized 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.
Receives: Drug: Aliskiren
PlaceboPlacebo comparatorRandomized 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (6)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: Baseline, 1 months, 6 months and 12 months

  3. 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.

    Measured: 6 months

  4. Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months

    Measured: 12 months

  5. 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.

    Measured: Baseline, 1 month, 6 months and 12 months

  6. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,639 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00894387
Sponsor's protocol ID
CSPP100A2368
Other IDs
2009-010236-18, 2009
Acronym
ASTRONAUT
Status last verified
Oct 2013
First submitted
5 May 2009
Last updated
7 Nov 2013

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.

    PubMed 29143416

  • 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.

    PubMed 29044915

  • 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.

    PubMed 28960673

  • 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.

    PubMed 23478743

  • 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.

    PubMed 21123186

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aliskiren in people with Acute Decompensated Heart Failure and Congestive Heart Failure, run by Novartis Pharmaceuticals at 308 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 308 sites in Germany, United States, Italy, Russia, Argentina and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00894387, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2013.

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