Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation (PURE)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

Adult patients, Signed informed consent form for participation in this study, Left ventricular ejection fraction =60%, NYHA Classification of III-IV, Persistency of right ventricular failure due to after load mismatch, Cava vein enlargement (between 1,5 and 2,5 cm, with respiratory collapse <50% or absent due to intravascular fluid overload), Decreased kidney function with mGFR between 15 and 60 ml/min/1.73m2, NT pro-BNP plasma concentration = 1000 pg/ml or BNP plasma concentration > 250 pg/ml, At least one episode of pulmonary or systemic congestion requiring high-dose intravenous diuretics in the 6 months before the study enrolment, Appropriate PUF technique candidate

Exclusion Criteria

Recipients of heart transplantation, End-stage renal disease (GFR < 15ml/min/1.73m2), Any major organ transplant (liver, lung, kidney), Lung embolism = 6 months before screening, Fibrotic lung disease, Liver cirrhosis (Child B or C), Absolute contraindication to peritoneal catheter implantation, Logistical and or organizational contra-indication to treatment, Active malignancy, 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, Female patients of childbearing age who do not use adequate contraception, Presence of a mechanical circulatory support device, Unwilling or unable to give informed consent, 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, Ipersensibility to Icodextrin, L-Carnitine, D-xilitol and other PolyCore components, 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, Hypertrophic obstructive cardiomyopathy, Uncontrolled hypertension with systolic blood pressure = 160 mmHg, Severe valvular stenosis, Acute coronary syndrome = 6 months before screening, Active myocarditis, Cardiosurgical or Endoradiological heart procedures = 6 month before screening, CRT implantation or upgrading of PM or ICD to CRT = 6 months before screening

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate if the treatment with Peritoneal Ultrafiltration with PolyCore has an impact on the composite endpoint of patient’s mortality or worsening of patient’s condition;Secondary Objective: Evaluate the the improvement of patients’ conditions, Evaluate the changes in the Quality of Life, Evaluate the changes in the use of hospital resources, Evaluate the changes in NYHA class, Evaluate the changes in kidney function, Evaluate urine output and urine sodium preservation, Evaluate the changes in the sympathetic nerve tone, Evaluate the need of loop diuretic, Evaluate hospitalization requirements, Evaluate PolyCore safety;Primary end point(s): 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

Secondary Outcome Measures

Name	Time	Method

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