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. října 2013 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
1639
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Corrientes, Argentina, 3400
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Corrientes, Argentina, W3400
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Quilmes, Argentina, 1878
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19140
- Novartis Investigative Site
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Philadelphia, Pennsylvania, Spojené státy, 19102-1192
- Novartis Investigative Site
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Pittsburgh, Pennsylvania, Spojené státy, 15212
- Novartis Investigative Site
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South Carolina
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Charleston, South Carolina, Spojené státy, 29403
- Novartis Investigative Site
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South Dakota
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Rapid City, South Dakota, Spojené státy, 57701
- Novartis Investigative Site
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Tennessee
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Springfield, Tennessee, Spojené státy, 37172
- Novartis Investigative Site
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Texas
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Brownsville, Texas, Spojené státy, 78520
- Novartis Investigative Site
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Virginia
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Charlottesville, Virginia, Spojené státy, 22908
- Novartis Investigative Site
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Richmond, Virginia, Spojené státy, 23298
- Novartis Investigative Site
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Richmond, Virginia, Spojené státy, 23249
- Novartis Investigative Site
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-
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-
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Kaohsiung, Tchaj-wan, 807
- Novartis Investigative Site
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Keelung City, Tchaj-wan, 20401
- Novartis Investigative Site
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Lin-Ko, Tchaj-wan, 33305
- Novartis Investigative Site
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Taichung, Tchaj-wan, 40447
- Novartis Investigative Site
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Taipei, Tchaj-wan
- Novartis Investigative Site
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Taipei, Tchaj-wan, 112
- Novartis Investigative Site
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Brno, Česká republika, 636 00
- Novartis Investigative Site
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Brno - Bohunice, Česká republika, 625 00
- Novartis Investigative Site
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Olomouc, Česká republika, 775 20
- Novartis Investigative Site
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Prague 4, Česká republika, 146 24
- Novartis Investigative Site
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Prague 5, Česká republika, 150 00
- Novartis Investigative Site
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Praha 10, Česká republika, 100 34
- Novartis Investigative Site
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Praha 2, Česká republika, 128 08
- Novartis Investigative Site
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Slany, Česká republika, 27401
- Novartis Investigative Site
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Teplice, Česká republika, 415 29
- Novartis Investigative Site
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Znojmo, Česká republika, 669 02
- Novartis Investigative Site
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CZE
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Hradec Kralove, CZE, Česká republika, 500 05
- Novartis Investigative Site
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Madrid, Španělsko, 28046
- Novartis Investigative Site
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Madrid, Španělsko, 28007
- Novartis Investigative Site
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Madrid, Španělsko, 28040
- Novartis Investigative Site
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Andalucia
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Sanlúcar de Barrameda, Andalucia, Španělsko, 11540
- Novartis Investigative Site
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Villamartin, Andalucia, Španělsko, 11650
- Novartis Investigative Site
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Baleares
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Palma de Mallorca, Baleares, Španělsko, 07010
- Novartis Investigative Site
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Cataluña
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Barcelona, Cataluña, Španělsko, 08003
- Novartis Investigative Site
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Španělsko, 46014
- Novartis Investigative Site
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Galicia
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Santiago de Compostela, Galicia, Španělsko, 15706
- Novartis Investigative Site
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Madrid
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Majadanonda, Madrid, Španělsko, 28220
- Novartis Investigative Site
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Pozuelo de Alarcón, Madrid, Španělsko, 28223
- Novartis Investigative Site
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Göteborg, Švédsko, 416 85
- Novartis Investigative Site
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Stockholm, Švédsko, 141 86
- Novartis Investigative Site
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Stockholm, Švédsko, 118 83
- Novartis Investigative Site
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Stockholm, Švédsko, 182 88
- Novartis Investigative Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
Ostatní jména:
|
|
Komparátor placeba: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months
Časové okno: 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
Časové okno: 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
|
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Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months
Časové okno: 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
Časové okno: 12 months
|
12 months
|
|
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Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. května 2009
Primární dokončení (Aktuální)
1. srpna 2012
Dokončení studie (Aktuální)
1. srpna 2012
Termíny zápisu do studia
První předloženo
5. května 2009
První předloženo, které splnilo kritéria kontroly kvality
5. května 2009
První zveřejněno (Odhad)
7. května 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
7. listopadu 2013
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. října 2013
Naposledy ověřeno
1. října 2013
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CSPP100A2368
- 2009-010236-18 (Číslo EudraCT)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .