Using PolyCore for fluid removal in heart failure patients

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

This study is testing if a new treatment called PolyCore can help heart failure patients who still have symptoms feel better when added to their usual medications.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Iperboreal Pharma Srl (Industry-sponsored)
• Locations: 3 sites (Chieti and 2 other locations)
• Trial ID: NCT03994874 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of PolyCore (a combination of Polydextrin, L-Carnitine, and D-xylitol) for peritoneal ultrafiltration in adults with heart failure and reduced ejection fraction (HFrEF) who continue to experience symptoms despite standard medical therapy. Participants will be randomly assigned to receive either PolyCore treatment or continue with their prescribed heart failure medications alone for a duration of six months. The study includes an independent data safety monitoring board to ensure patient safety and will conduct interim analyses to adjust the sample size as needed based on early results. The goal is to determine if PolyCore can improve outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with HFrEF and NYHA Class III-IV symptoms despite optimal medical therapy.

Not a fit: Patients with preserved ejection fraction or those who do not meet the specific inclusion criteria will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with heart failure who are resistant to standard treatments.

How similar studies have performed: While similar approaches have been explored, this specific combination of PolyCore for peritoneal ultrafiltration in HFrEF patients is relatively novel.

Eligibility criteria

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.

Where this trial is running

Chieti and 2 other locations

• Ospedale Ss. Annunziata — Chieti, Italy (Recruiting)
• ASST FBF Sacco — Milan, Italy (Recruiting)
• Ospedale Monaldi — Naples, Italy (Recruiting)

Study contacts

• Study coordinator: Arduino Arduini, MD

Conditions Congestive Heart Failure