LEVOCARNITINE, MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, LACTIC ACID, XYLITOL, POLYDEXTROSE for Congestive heart failure

Inclusion criteria

• {"criterion_text":"-Adult patients"}
• {"criterion_text":"-Signed informed consent form for participation in this study"}
• {"criterion_text":"-Left ventricular ejection fraction ≤60%"}
• {"criterion_text":"-NYHA Classification of III-IV"}
• {"criterion_text":"-Persistency of right ventricular failure due to after load mismatch"}
• {"criterion_text":"-Cava vein enlargement (between 1,5 and 2,5 cm, with respiratory collapse <50% or absent due to intravascular fluid overload)"}
• {"criterion_text":"-Decreased kidney function with mGFR between 15 and 60 ml/min/1.73m2"}
• {"criterion_text":"-At least one episode of pulmonary or systemic congestion requiring high-dose intravenous diuretics in the 6 months before the study enrolment"}
• {"criterion_text":"-Appropriate PUF technique candidate"}

Exclusion criteria

• {"criterion_text":"-Recipients of heart transplantation within one year prior to the screening"}
• {"criterion_text":"-End-stage renal disease (GFR < 15ml/min/1.73m2)"}
• {"criterion_text":"-Any major organ transplant (liver, lung, kidney)"}
• {"criterion_text":"-Lung embolism ≤ 6 months before screening"}
• {"criterion_text":"-Fibrotic lung disease"}
• {"criterion_text":"-Liver cirrhosis (Child B or C)"}
• {"criterion_text":"-Absolute contraindication to peritoneal catheter implantation"}
• {"criterion_text":"-Logistical and or organizational contra-indication to treatment"}
• {"criterion_text":"-Active malignancy"}
• {"criterion_text":"-Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later"}
• {"criterion_text":"-Female patients of childbearing age who do not use adequate contraception"}
• {"criterion_text":"-Presence of a mechanical circulatory support device"}
• {"criterion_text":"-Unwilling or unable to give informed consent"}
• {"criterion_text":"-Enrolment in another clinical trial involving medical or device-based interventions during a) the 30 days before the screening or b) 5-times the half-life of the used investigational product"}
• {"criterion_text":"-Ipersensibility to Icodextrin, L-Carnitine, D-xilitol and other PolyCore components"}
• {"criterion_text":"-Evidence of any condition that, according to the investigators’ judgment, could expose the subject to undue risk and/or prevent the subject from participating in the study procedures and/or potentially affecting the study quality data"}
• {"criterion_text":"-Hypertrophic obstructive cardiomyopathy"}
• {"criterion_text":"-Uncontrolled hypertension with systolic blood pressure ≥ 160 mmHg"}
• {"criterion_text":"-Severe valvular stenosis"}
• {"criterion_text":"-Acute coronary syndrome ≤ 6 months before screening"}
• {"criterion_text":"-Active myocarditis"}
• {"criterion_text":"-Cardiosurgical or Endoradiological heart procedures ≤ 6 month before screening"}
• {"criterion_text":"-CRT implantation or upgrading of PM or ICD to CRT ≤ 6 months before screening"}

Primary endpoints

• {"endpoint_text":"-Composite end point of 1) patient mortality; 2) hospitalization for cardiovascular causes, including the need for i.v. diuretics and/or hemofiltration; 3) The need of increasing of ≥30% the initial daily dose of loop diuretic; 4) Worsening renal function defined as eGRF ˂10 ml/min/1,73 m2","definition_or_measurement_approach":"Composite of: patient mortality (vital status records), hospitalization for cardiovascular causes including documented need for IV diuretics or hemofiltration (hospital records), increase ≥30% in daily loop diuretic dose (medication dosing records), and worsening renal function defined as eGFR < 10 ml/min/1.73 m2 (laboratory eGFR measurement)."}

Secondary endpoints

• {"endpoint_text":"-6 min Walking distance (V1, V5, V8, V9)","definition_or_measurement_approach":"6-minute walk test measured at visits V1, V5, V8, V9."}
• {"endpoint_text":"-Quality of life by Kansas City Cardiomyopathy Questionnaire (V1, V5, V8, V9)","definition_or_measurement_approach":"Kansas City Cardiomyopathy Questionnaire administered at visits V1, V5, V8, V9."}
• {"endpoint_text":"-Decrease in NT pro-BNT level of >=25% or BNP of >=40% (V1, V5, V8, V9)","definition_or_measurement_approach":"Laboratory measurement of NT-proBNP or BNP at visits V1, V5, V8, V9; assessed as percent change with thresholds ≥25% for NT-proBNP or ≥40% for BNP."}
• {"endpoint_text":"-Change in NYHA class (V1, V5, V8, V9, Long term FU)","definition_or_measurement_approach":"NYHA functional class assessed at specified visits and long-term follow-up; change from baseline recorded."}
• {"endpoint_text":"-Hospitalization for intra-venous therapy with loop diuretic","definition_or_measurement_approach":"Number and occurrence of hospitalizations requiring IV loop diuretic therapy documented in hospital records."}
• {"endpoint_text":"-Requiring other methods of treatment [i.e. PUF or hemodialysis]","definition_or_measurement_approach":"Occurrence of patients requiring alternative treatments such as peritoneal ultrafiltration (PUF) or hemodialysis, recorded during follow-up."}
• {"endpoint_text":"-Hospitalization for all causes","definition_or_measurement_approach":"All-cause hospitalizations recorded from medical records."}
• {"endpoint_text":"-Worsening of renal function defined as % of change of GFR (V1, V3, V4, V5, V6, V7, V8, V9, Long term)","definition_or_measurement_approach":"Percent change in GFR measured at listed visits and long-term follow-up using laboratory measurements."}
• {"endpoint_text":"-Change in the cumulative daily dosage of loop diuretic","definition_or_measurement_approach":"Comparison of cumulative daily loop diuretic dose over time based on medication records."}
• {"endpoint_text":"-Use of hospital resources for cardiovascular causes","definition_or_measurement_approach":"Assessment of healthcare resource utilization for cardiovascular causes (hospital admissions, procedures) from records."}
• {"endpoint_text":"-The number of patients requiring hospitalization for intra-venous therapy with loop diuretic","definition_or_measurement_approach":"Count of patients who required hospitalization for IV loop diuretics."}
• {"endpoint_text":"-The number of patients increasing of ≥30% an equivalent of the daily dose of oral furosemide","definition_or_measurement_approach":"Count of patients with ≥30% increase in equivalent daily oral furosemide dose based on medication dosing records."}
• {"endpoint_text":"-Safety (adverse events, vital signs, physical examination, ECG, laboratory parameters)","definition_or_measurement_approach":"Safety assessed by collection and analysis of adverse events, vital signs, physical examinations, ECGs and laboratory parameters."}

Italy

Earliest CTIS Part Ii Submission Date

15-03-2024

Latest Decision Or Authorization Date

23-04-2026

Processing Time Days

769

Number Of Sites

6

Number Of Participants

84

Primary sponsor

Full Name

Iperboreal Pharma S.r.l.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Industria Farmaceutica Galenica Senese S.r.l.","duties_or_roles":"[{\"id\":994771,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Romania","full_name":"Infomed Fluids S.R.L.","duties_or_roles":"[{\"id\":994767,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Nubilaria S.r.l.","duties_or_roles":"[{\"id\":994768,\"code\":\"6\"},{\"id\":994769,\"code\":\"7\"}]","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Clinpharma S.r.l.","duties_or_roles":"[{\"id\":994770,\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}