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Peritoneal Ultrafiltration in Cardio Renal Syndrome.
Sponsor: Iperboreal Pharma Srl
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).
Official title: Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2025-04-16
Completion Date
2027-06
Last Updated
2025-05-16
Healthy Volunteers
No
Conditions
Interventions
PolyCore (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