Tests a peritoneal fluid treatment in adults with heart failure and reduced ejection fraction
Tests PolyCore peritoneal ultrafiltration in adults with reduced-ejection-fraction heart failure.
Plain-language title generated from the registry record
Registry title: Peritoneal Ultrafiltration in Cardio Renal Syndrome.
Key facts
- Where
- Bologna, Chieti, Lecce, Milan, and Naples, ItalySee the 6 sites
- Phase
- Phase 1/2
Where in Italy
- IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola MalpighiBologna, ItalyTaking people
- Universita' Degli Studi G. D'annunzio Di ChietiChieti, ItalyTaking people
- Ospedale Vito Fazzi LecceLecce, ItalyTaking people
- ASST Fatebenefratelli SaccoMilan, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Azienda Ospedaliera dei ColliNaples, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Iperboreal Pharma Srl
- Trial code
- NCT03994874EU 2024-512658-41-00
- Record updated
- 16 May 2025
- Original description
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).Read full original descriptionShow less
Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation.
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).
Inclusion: 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: Acute coronary syndrome ≤ 6 months before; 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; Any major organ transplant (liver, lung, kidney); Lung embolism ≤ 6 months before; Recipients of heart transplantation; Uncontrolled hypertension with systolic blood pressure ≥ 160 mmHg; Fibrotic lung disease; Active malignancy; 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; Patient with end-stage renal disease, GFR urea clearance + creatinine clearance/2 (<15 ml/min/1,73 m2 GFR); Female patients of childbearing age who do not use adequate contracteption; Presence of a mechanical circulatory support device; Hypertrophic obstructive cardiomyopathy; Severe valvular stenosis; Restrictive cardiomyopathy; Active myocarditis; Liver Cirrhosis; Absolute contraindication to peritoneal catheter implantation; Logistical and or organizational contra-indication to treatment; 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; Unwilling and unable to give informed consent; Enrolment in another clinical trial involving medical or device based interventions; Hypersensibility to IMP components.