A Phase 4 interventional study of Levosimendan and Placebo in Advanced Heart Failure, sponsored by Hospital Universitario de Canarias. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-18.
Sponsored by Hospital Universitario de Canarias · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether the treatment strategy of long-term intermittent every 30 days, continuous intravenous infusion for 24 hours of Levosimendan, associated to optimal contemporary treatment for advanced heart failure reduce the incidence of admission for heart failure worsening at 12 months follow up, compared with the strategy based solely in the optimal contemporary treatment for advanced heart failure.
Aims: To evaluate the efficacy and safety of long-term, intermittent intravenous administration for 24 hours of Levosimendan for the treatment of advanced heart failure. Main end-point: incidence of admission due to decompensation, defined as first admission to emergency services or hospitalization more than 12 hours due to heart failure worsening.
Secondary end-points: major cardiac events, serious adverse events, change in NYHA scale at baseline, 30 days, 6 and 12 months; effects on inflammatory and neurohormonal activation in heart failure, identify factors associated with better survival of patients, quality of life, cost-effectiveness of treatment.
Study Design: Prospective, randomized, double-blind placebo controlled trial.
Scope of the study: patients with advanced heart failure.
Study Subjects: Patients over 18 years old with advanced HF of any etiology, with at least one admission for acute decompensation treated or treatable with Levosimendan within 6 months prior to randomization.
Interventions: a 24-hour infusion every 30 days of Levosimendan or placebo in addition to optimal pharmacological treatment for HF during 12 months.
Determinations: clinical monitoring, protocol-specified analytical determinations, echocardiographic assessment, invasive hemodynamic assessment, functional assessment by 6 min walk test in corridor, quality of life assessment at baseline, after 30 days, 6 months and 12 months.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 213 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Hospital Universitario de Canarias is the lead sponsor of 30 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
infusion of levosimendan at doses of 0.1 mcg / kg / min for 24 hours.
Drug: Levosimendan
infusion of placebo for 24 hours.
Drug: Levosimendan · Drug: Placebo
Patients included in the intervention group receive optimal drug therapy for heart failure symptoms and also infusion of levosimendan at doses of 0.1 mcg / kg / min for 24 hours every 30 days. Failure to reach an appropriate level of heart failure compensation before the deadline of 30 days for the next study drug administration or placebo, the administration of them will be every 15 days. Thereafter, failure to reach an appropriate level of heart failure compensation for patients or worsen after two consecutive infusions of study drug or placebo every 15 days, proceed to open the code patient randomization and and apply the most appropriate treatment.
Patients included in the placebo group receive optimal drug therapy for heart failure and also infusion of placebo at the same infusion rate as levosimendan doses of 0.1 mcg / kg / min for 24 hours every 30 days. Failure to reach an appropriate level of heart failure compensation before the deadline of 30 days for the next study drug administration or placebo, the administration of them will be every 15 days. Thereafter, failure to reach an appropriate level of heart failure compensation for patients or worsen after two consecutive infusions of study drug or placebo every 15 days, proceed to open the code patient randomization and and apply the most appropriate treatment.
Evaluate the incidence of admission for heart failure worsening in patients with advanced heart failure, defined as first admission to emergency services or hospitalization more than 12 hours due to a heart failure worsening.
Time frame: one year
Time from randomization until first hospitalization for heart failure worsening. All-cause mortality. Major cardiac events. Serious adverse events. Changes in NYHA scale and quality of life of patients. To analyze the cost-effectiveness of treatment.
Time frame: one year
This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Hospital Universitario de Canarias