Sign in

NCT03994874RecruitingPhase 1/2

Peritoneal Ultrafiltration in Cardio Renal Syndrome.

Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation.

Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
84 (estimated)
First submitted
20 Jun 2019
Start date
16 Apr 2025
Primary completion date
31 Dec 2026
Lead sponsor
Iperboreal Pharma Srl
NCT number
NCT03994874
EU CT number
2024-512658-41-00
EudraCT number
2019-004670-25

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 84
  • From 16 Apr 2025 to the primary completion date, 31 Dec 2026
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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.

Lab values

  • Patient with end-stage renal disease, GFR urea clearance + creatinine clearance/2 (\<15 ml/min/1,73 m2 GFR)

Age

  • Female patients of childbearing age who do not use adequate contracteption.

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
Universita' Degli Studi G. D'annunzio Di Chieti
Coordinator of this site? Confirm its status
ChietiItalyRecruiting
Ospedale Vito Fazzi Lecce
Coordinator of this site? Confirm its status
LecceItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Coordinator of this site? Confirm its status
MilanItalyRecruiting
ASST Fatebenefratelli Sacco
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Azienda Ospedaliera dei Colli
Coordinator of this site? Confirm its status
NaplesItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.