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)
2013년 10월 15일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
1639
단계
- 3단계
연락처 및 위치
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Nagpur, Maharashtra, 인도, 440010
- Novartis Investigative Site
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Nagpur, Maharashtra, 인도, 440012
- Novartis Investigative Site
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Pune, Maharashtra, 인도, 411004
- Novartis Investigative Site
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Pune, Maharashtra, 인도, 411011
- Novartis Investigative Site
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Pune, Maharashtra, 인도, 411030
- Novartis Investigative Site
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Tamil Nadu
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Coimbatore, Tamil Nadu, 인도, 641014
- Novartis Investigative Site
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Coimbatore, Tamil Nadu, 인도, 641037
- Novartis Investigative Site
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Brno, 체코 공화국, 636 00
- Novartis Investigative Site
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Brno - Bohunice, 체코 공화국, 625 00
- Novartis Investigative Site
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Olomouc, 체코 공화국, 775 20
- Novartis Investigative Site
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Prague 4, 체코 공화국, 146 24
- Novartis Investigative Site
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Prague 5, 체코 공화국, 150 00
- Novartis Investigative Site
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Praha 10, 체코 공화국, 100 34
- Novartis Investigative Site
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Praha 2, 체코 공화국, 128 08
- Novartis Investigative Site
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Slany, 체코 공화국, 27401
- Novartis Investigative Site
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Teplice, 체코 공화국, 415 29
- Novartis Investigative Site
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Znojmo, 체코 공화국, 669 02
- Novartis Investigative Site
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CZE
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Hradec Kralove, CZE, 체코 공화국, 500 05
- Novartis Investigative Site
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Ankara, 칠면조, 06500
- Novartis Investigative Site
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Atakum / Samsun, 칠면조, 55139
- Novartis Investigative Site
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Etlik / Ankara, 칠면조, 06018
- Novartis Investigative Site
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Istanbul, 칠면조, 34303
- Novartis Investigative Site
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Istanbul, 칠면조, 34304
- Novartis Investigative Site
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Izmir, 칠면조, 35040
- Novartis Investigative Site
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Izmir, 칠면조, 35340
- Novartis Investigative Site
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Kirikkale, 칠면조, 71100
- Novartis Investigative Site
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Kocaeli, 칠면조, 41380
- Novartis Investigative Site
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Sivas, 칠면조, 58140
- Novartis Investigative Site
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Talas / Kayseri, 칠면조, 38039
- Novartis Investigative Site
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, 캐나다, A1B 3V6
- Novartis Investigative Site
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 2Y9
- Novartis Investigative Site
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Ontario
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Ottawa, Ontario, 캐나다, K1Y 4W7
- Novartis Investigative Site
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Toronto, Ontario, 캐나다, M5B 1W8
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, 캐나다, H3T 1E2
- Novartis Investigative Site
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Montreal, Quebec, 캐나다, H3A 1A1
- Novartis Investigative Site
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Barranquilla, 콜롬비아
- Novartis Investigative Site
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Bogotá, 콜롬비아
- Novartis Investigative Site
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Bogotá, 콜롬비아, 0000
- Novartis Investigative Site
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Cali, 콜롬비아
- Novartis Investigative Site
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Florida Blanca, 콜롬비아
- Novartis Investigative Site
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Atlantico
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Barranquilla, Atlantico, 콜롬비아
- Novartis Investigative Site
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Cundinamarca
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Bogotá, Cundinamarca, 콜롬비아
- Novartis Investigative Site
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Grodzisk Wielkopolski, 폴란드, 62-065
- Novartis Investigative Site
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Klodzko, 폴란드, 57-300
- Novartis Investigative Site
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Kraków, 폴란드, 31-531
- Novartis Investigative Site
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Lublin, 폴란드, 20-954
- Novartis Investigative Site
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Lódz, 폴란드, 91-347
- Novartis Investigative Site
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Ruda Slaska, 폴란드, 41-703
- Novartis Investigative Site
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Swidnica, 폴란드, 58-100
- Novartis Investigative Site
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Szczecin, 폴란드, 70-111
- Novartis Investigative Site
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Walbrzych, 폴란드, 58-309
- Novartis Investigative Site
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Warszawa, 폴란드, 04-628
- Novartis Investigative Site
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Warszawa, 폴란드, 03-242
- Novartis Investigative Site
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Wroclaw, 폴란드, 50-367
- Novartis Investigative Site
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Wroclaw, 폴란드, 50-981
- Novartis Investigative Site
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Zabrze, 폴란드, 41-800
- Novartis Investigative Site
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Zamosc, 폴란드, 22-400
- Novartis Investigative Site
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Bordeaux Cedex, 프랑스, 33075
- Novartis Investigative Site
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Grenoble, 프랑스, 38043
- Novartis Investigative Site
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Le Chesnay, 프랑스
- Novartis Investigative Site
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Paris, 프랑스, 75013
- Novartis Investigative Site
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Paris, 프랑스, 75571
- Novartis Investigative Site
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Pessac Cedex, 프랑스, 33604
- Novartis Investigative Site
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Pontoise, 프랑스, F-95300
- Novartis Investigative Site
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Toulouse Cedex, 프랑스, 31059
- Novartis Investigative Site
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Jyvaskyla, 핀란드, FIN-40620
- Novartis Investigative Site
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Turku, 핀란드, 20520
- Novartis Investigative Site
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Manila, 필리핀 제도, 1000
- Novartis Investigative Site
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Quezon City, 필리핀 제도, 1100
- Novartis Investigative Site
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Metro Manila
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Quezon City, Metro Manila, 필리핀 제도, 1109
- Novartis Investigative Site
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Balatonfured, 헝가리, H-8231
- Novartis Investigative Site
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Budapest, 헝가리, 1027
- Novartis Investigative Site
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Budapest, 헝가리, 1096
- Novartis Investigative Site
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Budapest, 헝가리, H-1106
- Novartis Investigative Site
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Hodmezovasarhely, 헝가리, 6800
- Novartis Investigative Site
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Nagykanizsa, 헝가리, 8800
- Novartis Investigative Site
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Szolnok, 헝가리, H-5000
- Novartis Investigative Site
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Zalaegerszeg, 헝가리, 8900
- Novartis Investigative Site
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Baranya
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Pecs, Baranya, 헝가리, 7621
- Novartis Investigative Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
|
|
위약 비교기: 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.
|
위약
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 5월 1일
기본 완료 (실제)
2012년 8월 1일
연구 완료 (실제)
2012년 8월 1일
연구 등록 날짜
최초 제출
2009년 5월 5일
QC 기준을 충족하는 최초 제출
2009년 5월 5일
처음 게시됨 (추정)
2009년 5월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 11월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 10월 15일
마지막으로 확인됨
2013년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .