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

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What is this study about?

This clinical trial is focused on studying a condition known as , which is a type of heart disease where the heart is unable to pump blood effectively. The study will use a treatment called with a solution named . This solution is used in a process called peritoneal dialysis, which helps remove excess fluid from the body. contains several substances, including , , , , , , and . These ingredients work together to help manage fluid levels in the body.

The purpose of this study is to evaluate whether treatment with using can impact the health outcomes of patients with . The study will monitor patients to see if the treatment affects their overall health, including the risk of hospitalization or worsening of their condition. Participants will receive the treatment over a period of time, and their health will be regularly assessed to gather information on the treatment’s effectiveness and safety.

Throughout the study, participants will undergo various assessments, such as measuring their ability to walk a certain distance and evaluating their quality of life. The study will also track changes in specific health markers, like levels of certain proteins in the blood that are related to heart function. The goal is to determine if with can help improve the management of and potentially reduce the need for other treatments, such as intravenous diuretics or hemodialysis.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Ospedale Vito Fazzi Lecce Lecce Italy
ASST Fatebenefratelli Sacco Milan Italy
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Aikhhjt Upamt Sobxdmrsf Lxcepp Di Bnayijz Bologna Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
20.02.2025

Trial locations

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.

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 ID:
2024-512658-41-00
Protocol code:
CQ-001-19
NCT ID:
NCT03994874
Trial Phase:
Therapeutic use (Phase IV)

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