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RECRUITING
NCT03994874
PHASE1/PHASE2

Peritoneal Ultrafiltration in Cardio Renal Syndrome.

Sponsor: Iperboreal Pharma Srl

View on ClinicalTrials.gov

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

Interventions

DRUG

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