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)
tiistai 15. lokakuuta 2013 päivittänyt: 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.
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Sylmar, California, Yhdysvallat, 91342
- Novartis Investigative Site
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Torrance, California, Yhdysvallat, 90502
- Novartis Investigative Site
-
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Connecticut
-
Hartford, Connecticut, Yhdysvallat, 06102-5037
- Novartis Investigative Site
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District of Columbia
-
Washington, District of Columbia, Yhdysvallat, 20037
- Novartis Investigative Site
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Washington, District of Columbia, Yhdysvallat, 20010-2975
- Novartis Investigative Site
-
-
Florida
-
Jacksonville, Florida, Yhdysvallat, 32207
- Novartis Investigative Site
-
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Georgia
-
Macon, Georgia, Yhdysvallat, 31201
- Novartis Investigative Site
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Illinois
-
Oakbrook Terrace, Illinois, Yhdysvallat, 60181
- Novartis Investigative Site
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Iowa
-
Iowa City, Iowa, Yhdysvallat, 52245
- Novartis Investigative Site
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Louisiana
-
Lafayette, Louisiana, Yhdysvallat, 70501
- Novartis Investigative Site
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Michigan
-
Detroit, Michigan, Yhdysvallat, 48202
- Novartis Investigative Site
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Kalamazoo, Michigan, Yhdysvallat, 49048
- Novartis Investigative Site
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-
Missouri
-
St. Louis, Missouri, Yhdysvallat, 63110
- Novartis Investigative Site
-
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New Jersey
-
Cherry Hill, New Jersey, Yhdysvallat, 08034
- Novartis Investigative Site
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Newark, New Jersey, Yhdysvallat, 07103-2714
- Novartis Investigative Site
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New York
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Bronx, New York, Yhdysvallat, 10461
- Novartis Investigative Site
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Buffalo, New York, Yhdysvallat, 14215
- Novartis Investigative Site
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Buffalo, New York, Yhdysvallat, 14203
- Novartis Investigative Site
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Saratoga Springs, New York, Yhdysvallat, 12866
- Novartis Investigative Site
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North Carolina
-
Chapel Hill, North Carolina, Yhdysvallat, 27599-7075
- Novartis Investigative Site
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Ohio
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Cincinnati, Ohio, Yhdysvallat, 45219
- Novartis Investigative Site
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Cincinnati, Ohio, Yhdysvallat, 45267-0585
- Novartis Investigative Site
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Cleveland, Ohio, Yhdysvallat, 44109-1998
- Novartis Investigative Site
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Pennsylvania
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Philadelphia, Pennsylvania, Yhdysvallat, 19140
- Novartis Investigative Site
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Philadelphia, Pennsylvania, Yhdysvallat, 19102-1192
- Novartis Investigative Site
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Pittsburgh, Pennsylvania, Yhdysvallat, 15212
- Novartis Investigative Site
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29403
- Novartis Investigative Site
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South Dakota
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Rapid City, South Dakota, Yhdysvallat, 57701
- Novartis Investigative Site
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Tennessee
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Springfield, Tennessee, Yhdysvallat, 37172
- Novartis Investigative Site
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Texas
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Brownsville, Texas, Yhdysvallat, 78520
- Novartis Investigative Site
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Virginia
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Charlottesville, Virginia, Yhdysvallat, 22908
- Novartis Investigative Site
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Richmond, Virginia, Yhdysvallat, 23298
- Novartis Investigative Site
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Richmond, Virginia, Yhdysvallat, 23249
- Novartis Investigative Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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
Muut nimet:
|
|
Placebo Comparator: Placebo
Randomized patients in this arm received matching placebo of Aliskiren.
At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
|
Plasebo
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Perjantai 1. toukokuuta 2009
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 1. elokuuta 2012
Opintojen valmistuminen (Todellinen)
Keskiviikko 1. elokuuta 2012
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 5. toukokuuta 2009
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 5. toukokuuta 2009
Ensimmäinen Lähetetty (Arvio)
Torstai 7. toukokuuta 2009
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Torstai 7. marraskuuta 2013
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 15. lokakuuta 2013
Viimeksi vahvistettu
Tiistai 1. lokakuuta 2013
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- CSPP100A2368
- 2009-010236-18 (EudraCT-numero)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .