Levosimendan for Heart failure with reduced ejection fraction (HFrEF)

Inclusion criteria

• {"criterion_text":"- Age> 18 years\n- FEVI <35% for echocardiography in the last 6 months\n- Functional class NYHA> III with functional impairment despite optimized treatment of HF and diuretic with admission or decompensation treated on an outpatient basis with diuretic in the last six months that motivate the implementation of the CardioMEMS device\n- Signing of informed consent"}

Exclusion criteria

• {"criterion_text":"- Creatinine clearance <20 ml / min\n- Presión arterial sistólica <90 mmHg\n- Pregnant or fertile women (who are in the period between menorrhagia and menopause) without effective contraceptive coverage, or in breastfeeding\n- Hypersensitivity to the active ingredients or to any of the excipients"}

Primary endpoints

• {"endpoint_text":"- Pulmonary blood pressure measured in mmhg and cardiac output measured in l / min at 3 months","definition_or_measurement_approach":"Measured in mmHg and L/min using the CardioMEMS device at 3 months."}

Secondary endpoints

• {"endpoint_text":"- Combined criteria for death or rehospitalization for heart failure at the beginning and end of each period\n- Scores observed in the EuroQoL-5D quality of life test at the beginning and end of each period.\n- Scores observed in the 6-minute test at the beginning and end of each period\n- CA125, ST2, TnT and NTProBNP levels at the beginning and end of each period.\n- Pulmonary congestion parameters by pulmonary ultrasound: B lines\n- Renal function parameters:% of glomerular filtrate or creatinine levels (mg / dl), hypotension (systolic blood pressure <100mmHg).\n- Adverse events resulting from the administration of the drug","definition_or_measurement_approach":"Combined death/rehospitalisation assessed at start and end of each period; EuroQoL-5D scores measured by the EuroQoL-5D instrument at start/end of each period; 6-minute walk test (6MWT) scores measured at start/end of each period; Biomarkers (CA125, ST2, TnT, NT-proBNP) measured in blood at start/end of each period; Pulmonary congestion assessed by lung ultrasound B-lines; Renal function assessed by % glomerular filtration rate or serum creatinine (mg/dL) and hypotension defined as systolic BP <100 mmHg; Adverse events recorded during/after drug administration per safety reporting."}

Spain

Earliest CTIS Part Ii Submission Date

26-11-2024

Latest Decision Or Authorization Date

03-12-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain