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 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1639
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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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, Ungarn, H-8231
- Novartis Investigative Site
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Budapest, Ungarn, 1027
- Novartis Investigative Site
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Budapest, Ungarn, 1096
- Novartis Investigative Site
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Budapest, Ungarn, H-1106
- Novartis Investigative Site
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Hodmezovasarhely, Ungarn, 6800
- Novartis Investigative Site
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Nagykanizsa, Ungarn, 8800
- Novartis Investigative Site
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Szolnok, Ungarn, H-5000
- Novartis Investigative Site
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Zalaegerszeg, Ungarn, 8900
- Novartis Investigative Site
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Baranya
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Pecs, Baranya, Ungarn, 7621
- Novartis Investigative Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
Andre navne:
|
|
Placebo komparator: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2009
Primær færdiggørelse (Faktiske)
1. august 2012
Studieafslutning (Faktiske)
1. august 2012
Datoer for studieregistrering
Først indsendt
5. maj 2009
Først indsendt, der opfyldte QC-kriterier
5. maj 2009
Først opslået (Skøn)
7. maj 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. november 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. oktober 2013
Sidst verificeret
1. oktober 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CSPP100A2368
- 2009-010236-18 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .