Peritoneal Ultrafiltration in Cardio Renal Syndrome.

Summary

Randomized, controlled, unblinded, adaptive design clinical trial to evaluate the safety and efficacy of PolyCore (Polydextrin, L-Carnitine, D-xylitol) peritoneal ultrafiltration (PUF) in patients with heart failure and reduced ejection fraction (HFrEF).

Eligibility

Inclusion Criteria:

* Age ≥18 yrs
* Left ventricular ejection fraction ≤60%
* NYHA Classification of III-IV despite guidelines directed medical therapy
* Right ventricular failure due to after load mismatch, addressed by the presence of tricuspid calve regurgitation (≥ moderate) and by the disproportioned increase of the right atrial pressure (RAP) versus the capillary wedge pressure (CWP) with a ratio ≥0.65, detected with right heart catheterization performed after stable medical therapy according to international guidelines and comprehensive of loop diuretic (equivalent to furosemide oral dose till 2.0 mg/kg/day), coupled with urinary sodium excretion ≤ mEq/L, confirmatory of loop diuretic resistance.
* Cava vein enlargement (inner diameter, detected with focused echocardiography, between 1,5 and 2,5 cm, with respiratory collapse \<50% or absent due to intravascular fluid overload)
* Decreased kidney function addressed by the measurement of glomerular filtration rate (GFR) urea clearance + creatinine clearance/2 (\>15 ml/min/1,73 m2)
* 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 (or diuretic combinations) in the 6 months befor the study enrollment
* An appropriate PUF technique candidate.
* Signed informed consent

Exclusion Criteria:

* Recipients of heart transplantation
* Presence of a mechanical circulatory support device;
* Hypertrophic obstructive cardiomyopathy;
* Uncontrolled hypertension with systolic blood pressure ≥ 160 mmHg
* Severe valvular stenosis;
* Restrictive cardiomyopathy;
* Acute coronary syndrome ≤ 6 months before;
* Active myocarditis
* Cardiosurgical or Endo-radiological heart procedures ≤ 6 months before
* Cardiac resynchronization therapy (CRT) implantation or upgrading of pacemaker (PM) or implantable cardioverter defibrillator (ICD) to CRT ≤ 6 months before;
* Patient with end-stage renal disease, GFR urea clearance + creatinine clearance/2 (\<15 ml/min/1,73 m2 GFR)
* Any major organ transplant (liver, lung, kidney)
* Lung embolism ≤ 6 months before;
* Fibrotic lung disease;
* Liver Cirrhosis;
* 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 trial and for three months later
* Female patients of childbearing age who do not use adequate contracteption.
* Unwilling and unable to give informed consent;
* Enrolment in another clinical trial involving medical or device based interventions.
* Hypersensibility to IMP 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 afftecting the study quality data.

Conditions2

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