Peritoneal Ultrafiltration in Cardio Renal Syndrome.

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test L-Carnitine.

It had two arms (groups): PolyCore PUF (experimental) and Control (no intervention).

PolyCore peritoneal ultrafiltration (PUF) (over the top of patient's prescribed heart failure medications), for 6 months.

Patients in the control arm (receiving no PUF therapy) will remain on their prescribed heart failure medications.

The registry classes the interventions as drug.

More on the Plan

The study will include adults HFrEF patients, that despite guidelines directed medical therapy still retain a congestive heart failure (HF) picture.

The PUF ultrafiltration will be performed with a single nightly exchange, with 2 liters PolyCore solution, lasting 12-14 hours, for 6 months.

An independent data safety monitoring board (DSMB) will be convened for this study and will review the results of the trial at regular intervals to protect patients participating in the study.

An adaptive interim analysis will be performed when in each group 20 patients have completed 6 months in the study, for analysis of the primary outcome.

Who Took Part

The registry lists 84 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥18 yrs. NYHA Classification of III-IV despite guidelines directed medical therapy. NT pro-BNP plasma concentration \> 1000 pg/ml or BNP plasma concentration \> 250 pg/ml. An appropriate PUF technique candidate. Signed informed consent.

The full record lists 10 inclusion and 24 exclusion criteria; among the exclusions: recipients of heart transplantation; presence of a mechanical circulatory support device;; hypertrophic obstructive cardiomyopathy;.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether L-Carnitine was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2025-04-16 with completion listed for 2026-12.

It ran at 3 sites in Italy (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Composite end-point of mortality and worsening patient's condition (time frame: Up to 7 months from randomization).

It also tracked 10 secondary outcomes, for example 6 min Walking distance, Quality of life tested with Kansas City Cardiomyopathy Questionnaire (KCCQ), Worsening of renal function, Use of hospital resources, New York Heart Association (NYHA) class and Number of patients requiring hospitalization.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of L-Carnitine in 84 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.