Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure (LAICA)

Study Type:

Interventional 

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Triple (Participant, Care Provider, Investigator)

Primary Purpose: Treatment

Official Title:

Double-blind Randomized Placebo-controlled Study to Evaluate the Efficacy and Safety of Intermittent, Long-term Administration of Levosimendan in Patients With Advanced Heart Failure

 

Resource links provided by NLM:

 

MedlinePlus related topics: Heart Failure 

U.S. FDA Resources 

 

Further study details as provided by Martín J García González, Hospital Universitario de Canarias:

 

Primary Outcome Measures: 

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 ]

 

Secondary Outcome Measures: 

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 ]

 

 

Estimated Enrollment:

213

Study Start Date:

November 2009

Estimated Study Completion Date:

December 2014

Estimated Primary Completion Date:

December 2013 (Final data collection date for primary outcome measure)