Plain-English translation of NCT03994874 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial is testing PolyCore PUF, a nightly fluid removal treatment designed to help people with severe heart failure whose symptoms aren't fully controlled by medications alone. The treatment involves a special solution that removes excess fluid from your body overnight, similar to dialysis. Researchers want to see if this extra step—combined with your regular heart failure medicines—can keep you out of the hospital and feeling better.
Many people with severe heart failure struggle with fluid buildup even while taking strong medications, which leads to repeated hospitalizations. This medication aims to provide an additional way to remove that dangerous fluid buildup and reduce the strain on your heart and kidneys.
You likely qualify if…
You likely don't qualify if…
If you enroll, you'll be randomly assigned to either receive the nightly fluid removal treatment (in addition to your regular heart failure medications) or continue with your current medications only. Those receiving the treatment will perform a 12–14 hour overnight exchange with a special solution once per day for 6 months. You'll continue taking all your regular heart failure medications as prescribed. The study will include office visits and heart tests to monitor your progress, and a safety board will review results regularly to ensure your well-being.
AI-generated summary from trial data · Jun 19, 2026 · Not medical advice
Italy
Phase
Safety & dosing / Early efficacy
Sponsor
Iperboreal Pharma Srl
Enrollment target
~84 participants
Started
April 2025
Primary completion
December 2026
Age range
18 Years and older
Last updated on clinicaltrials.gov in May 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Arduino Arduini, MD
Policlinico Milano - on behalf of Cardio Renal and Metabolism Working Group of the ANMCO
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.