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Study on Peritoneal Ultrafiltration with PolyCore for Patients with Congestive Heart Failure Using Levocarnitine and Drug Combination

Verified siteFast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Congestive Heart Failure, a condition in which the heart cannot pump blood effectively, leading to fluid buildup in the body. The treatment being tested involves a procedure called peritoneal ultrafiltration, which uses a fluid solution placed into the abdominal cavity to help remove excess fluid. The solution, known as PolyCore, contains several substances including levocarnitine, magnesium chloride, sodium chloride, calcium chloride, lactic acid, xylitol, and polydextrose, and is designed for use during the dialysis process that cleans the blood.

The purpose of the study is to determine whether this treatment can reduce the risk of death or worsening of the condition. Participants will have the solution introduced into the abdomen on a regular schedule and will attend periodic visits where simple tests are performed, such as a short walking test to assess stamina, questionnaires about quality of life, and blood draws to measure heart‑related proteins. Kidney function will be checked using a measure called eGFR, and medication use, including any increase in dosage of a loop diuretic (a drug that helps the body get rid of extra fluid), will be recorded.

Throughout the study, safety will be closely monitored through routine checks of vital signs, physical examinations, heart rhythm recordings, and laboratory results. Participants will continue the treatment for the planned study period, with follow‑up visits at several time points to track health status and any side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will begin treatment with a solution called PolyCore. This solution is used for peritoneal dialysis, a process that helps remove excess fluid and waste products from the body.

    The solution contains several active substances, including levocarnitine, magnesium chloride hexahydrate, sodium chloride, calcium chloride dihydrate, lactic acid, xylitol, and polydextrose.

  2. Step 2

    Treatment administration

    The PolyCore solution is administered intraperitoneally, meaning it is introduced into the peritoneal cavity, the space within the abdomen that houses the intestines, liver, and other organs.

    The frequency and duration of the treatment will be determined by the healthcare provider based on the patient's specific condition and response to the treatment.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, the patient's health will be closely monitored. This includes regular assessments of heart and kidney function, as well as overall health status.

    The primary goal is to evaluate whether the treatment impacts the patient's mortality or the worsening of their condition.

  4. Step 4

    Assessments and tests

    The patient will undergo various assessments, such as the 6-minute walking test and quality of life evaluations using the Kansas City Cardiomyopathy Questionnaire.

    Blood tests will be conducted to measure levels of NT pro-BNP or BNP, which are indicators of heart failure.

  5. Step 5

    End of trial

    The trial is expected to conclude by April 1, 2027. At the end of the trial, the patient's overall health and response to the treatment will be thoroughly evaluated.

    The results will help determine the effectiveness of the PolyCore solution in managing symptoms and preventing the worsening of heart failure in patients with cardio-renal syndrome.

Who can join the trial?

10 criteria

  • Must be an adult patient.
  • Must have signed an informed consent form to participate in the study. This means you agree to join the study after understanding what it involves.
  • Must have a left ventricular ejection fraction of 60% or less. This is a measure of how well the heart is pumping blood.
  • Must be classified as NYHA Class III-IV. This is a way to describe the severity of heart failure symptoms, with III and IV being more severe.
  • Must have ongoing right ventricular failure due to a mismatch in pressure after the heart pumps blood.
  • Must have cava vein enlargement between 1.5 and 2.5 cm, with less than 50% or no collapse when breathing in, due to too much fluid in the blood vessels.
  • Must have decreased kidney function with a measurement called mGFR between 15 and 60 ml/min/1.73m2. This shows how well the kidneys are working.
  • Must have a NT pro-BNP plasma concentration of 1000 pg/ml or more, or a BNP plasma concentration greater than 250 pg/ml. These are blood tests that help measure heart stress.
  • Must have had at least one episode of pulmonary or systemic congestion that needed high-dose intravenous diuretics in the 6 months before joining the study. This means having too much fluid in the lungs or body that required strong medication to remove.
  • Must be a suitable candidate for the PUF technique, which is a specific treatment method used in the study.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Congestive Heart Failure cannot participate. Congestive Heart Failure is a condition where the heart doesn't pump blood as well as it should.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Peritoneal Ultrafiltration with PolyCore is a therapy used in this clinical trial. It involves a process where excess fluid is removed from the body through the peritoneum, a membrane in the abdomen. This method is being tested to see if it can help prevent worsening heart failure or reduce the risk of death in patients with cardio-renal syndrome.

What is already known about the treatment

PolyCore – PolyCore is administered through peritoneal ultrafiltration, a method where fluid is removed from the body via the peritoneal cavity. It is currently being studied in clinical trials to assess its effectiveness in treating congestive heart failure, particularly in preventing exacerbations related to cardio-renal syndrome. The main therapeutic indication is to manage fluid overload in patients with heart failure. At the molecular level, PolyCore works by facilitating the removal of excess fluid, thereby reducing the strain on the heart and kidneys. It is classified pharmacologically as a device used in fluid management therapy.

Investigated diseases

Congestive Heart Failure – Congestive Heart Failure is a condition where the heart is unable to pump blood effectively, leading to a buildup of fluid in the lungs and other parts of the body. This can cause symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. Over time, the heart's ability to pump blood may continue to decline, resulting in worsening symptoms. The condition can lead to frequent hospitalizations due to the need for treatments like intravenous diuretics. Patients may also experience a decrease in their ability to perform physical activities, such as walking. The progression of the disease can also affect kidney function, leading to further complications.
Trial detailsLast updated 9 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-512658-41-00Protocol codeCQ-001-19Estimated enrolment84 patientsSponsorIperboreal Pharma S.r.l.

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