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
- Diseases
- Heart failure
- 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
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Universita' Degli Studi G. D'annunzio Di Chieti Coordinator of this site? Confirm its status | Chieti | Italy | Recruiting |
| Ospedale Vito Fazzi Lecce Coordinator of this site? Confirm its status | Lecce | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.