Back to Search
Start Over
Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period
- Source :
- Dipòsit Digital de la UB, Universidad de Barcelona, Pölzl, G, Allipour Birgani, S, Comín-Colet, J, Delgado, J F, Fedele, F, García-Gonzáles, M J, Gustafsson, F, Masip, J, Papp, Z, Störk, S, Ulmer, H, Vrtovec, B, Wikström, G & Altenberger, J 2019, ' Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period ', ESC heart failure, vol. 6, no. 1, pp. 174-181 . https://doi.org/10.1002/ehf2.12366, ESC Heart Failure
- Publication Year :
- 2018
- Publisher :
- John Wiley & Sons, 2018.
-
Abstract
- Hospitalization for acute heart failure (HF) is associated with a substantial morbidity burden and with associated healthcare costs and an increased mortality risk. However, few if any major medical innovations have been witnessed in this area in recent times. Levosimendan is a first‐in‐class calcium sensitizer and potassium channel opener indicated for the management of acute HF. Experience in several clinical studies has indicated that administration of intravenous levosimendan in intermittent cycles may reduce hospitalization and mortality rates in patients with advanced HF; however, none of those trials were designed or powered to give conclusive insights into that possibility. This paper describes the rationale and protocol of LeoDOR (levosimendan infusions for patients with advanced chronic heart failure), a randomized, double‐blind, placebo‐controlled, international, multicentre trial that will explore the efficacy and safety of intermittent levosimendan therapy, in addition to optimized standard therapy, in patients following hospitalization for acute HF. Salient features of LeoDOR include the use of two treatment regimens, in order to evaluate the effects of different schedules and doses of levosimendan during a 12 week treatment phase, and the use of a global rank primary endpoint, in which all patients are ranked across three hierarchical groups ranging from time to death or urgent heart transplantation or implantation of a ventricular assist device to time to rehospitalization and, lastly, time‐averaged proportional change in N‐terminal pro‐brain natriuretic peptide. Secondary endpoints include changes in HF symptoms and functional status at 14 weeks.
- Subjects :
- advanced heart failure
global rank endpoint
hospitalization
levosimendan
n-terminal pro-brain natriuretic peptide
randomized controlled trial
cardiotonic agents
dose-response relationship, drug
double-blind method
drug administration schedule
follow-up studies
heart failure
humans
infusions, intravenous
simendan
stroke volume
treatment outcome
patient discharge
Cardiotonic Agents
Levosimendan
Risk factors in diseases
Advanced heart failure
Study Designs
Heart failure
Insuficiència cardíaca
dose-response relationship
Drug Administration Schedule
Hospital patients
Clinical trials
Double-Blind Method
Humans
Cardiac and Cardiovascular Systems
Infusions, Intravenous
Simendan
Global rank endpoint
Heart Failure
Malalts hospitalitzats
Study Design
N‐terminal pro‐brain natriuretic peptide
Kardiologi
Dose-Response Relationship, Drug
Factors de risc en les malalties
drug
Stroke Volume
Patient Discharge
infusions
Hospitalization
N-terminal pro-brain natriuretic peptide
Treatment Outcome
Randomized controlled trial
intravenous
Follow-Up Studies
Assaigs clínics
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Dipòsit Digital de la UB, Universidad de Barcelona, Pölzl, G, Allipour Birgani, S, Comín-Colet, J, Delgado, J F, Fedele, F, García-Gonzáles, M J, Gustafsson, F, Masip, J, Papp, Z, Störk, S, Ulmer, H, Vrtovec, B, Wikström, G & Altenberger, J 2019, ' Repetitive levosimendan infusions for patients with advanced chronic heart failure in the vulnerable post-discharge period ', ESC heart failure, vol. 6, no. 1, pp. 174-181 . https://doi.org/10.1002/ehf2.12366, ESC Heart Failure
- Accession number :
- edsair.pmid.dedup....15e102f01222638e65ec229e5b13501b