drugset / Trial / NCT00894387
Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2009-05
- Primary completion
- 2012-08
- Completion
- 2012-08
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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aliskiren | Small molecule | 150 mg | — |
| Subject | Aliskiren | Small molecule | 300 mg | — |