RecruitingPhase 1Phase 2NCT03994874

Peritoneal Ultrafiltration in Cardio Renal Syndrome.

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


Sponsor

Iperboreal Pharma Srl

Enrollment

84 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a treatment called peritoneal ultrafiltration — using the lining of the belly to remove excess fluid — can help people with severe heart and kidney failure who no longer respond well to water pills (diuretics). **You may be eligible if...** - You are 18 or older - You have severe heart failure with significant fluid overload despite maximum medication - Your heart's pumping function is reduced (ejection fraction 60% or less) - You are in NYHA Class III or IV heart failure — meaning significant symptoms even at rest or with minimal activity - You have signs of right-sided heart failure and resistance to diuretics - You have had right heart catheterization confirming these findings **You may NOT be eligible if...** - Your kidneys are functioning normally and you do not have fluid overload - You do not have the specific pattern of heart-kidney failure this study targets - You are not on maximum guideline-directed heart failure medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPolyCore (Polydextrin, L-Carnitine, D-xylitol)

A single nightly exchange, with 2 liters PolyCore solution, lasting 12-14 hours. Patients should remain on their prescribed heart failure medications and the same dosing schedule for the duration of the study unless investigators determine medically necessary to change.


Locations(3)

Ospedale Ss. Annunziata

Chieti, Italy

ASST FBF Sacco

Milan, Italy

Ospedale Monaldi

Naples, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03994874


Related Trials