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Study on Managing Heart Failure and Kidney Disease in Elderly Patients with High Potassium Risk Using Sodium Zirconium Cyclosilicate

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What is this study about?

This clinical trial is focused on studying the management of heart failure and chronic kidney disease in elderly patients who have or are at high risk of developing hyperkalemia, which is a condition characterized by high levels of potassium in the blood. The study will use a treatment called Lokelma, which contains the active substance sodium zirconium cyclosilicate. Lokelma is available in two forms: a 5 g and a 10 g powder for oral suspension. The purpose of the study is to determine the best strategy for managing these conditions by optimizing the use of medications known as RAAS inhibitors (RAASi) with the help of Lokelma.

Participants in the study will be divided into groups. One group will receive Lokelma along with RAAS inhibitors, while the other group will receive RAAS inhibitors without Lokelma. The study will last for about three months, during which the effectiveness of the treatment will be monitored. The goal is to see if patients can safely increase their dose of RAAS inhibitors, which are important for managing heart failure and chronic kidney disease, by at least 25% compared to their initial dose. This will help determine if Lokelma can help patients better tolerate higher doses of RAAS inhibitors.

Throughout the study, various health parameters will be observed, such as changes in blood pressure and kidney function, as well as the number of hospital visits related to heart failure, hyperkalemia, or impaired kidney function. The study aims to provide valuable insights into how Lokelma can be used to improve the management of heart failure and chronic kidney disease in elderly patients, potentially leading to better health outcomes and quality of life.

1 study inclusion

Upon joining the study, the patient will be assessed to ensure they meet the necessary criteria, such as age and medical history related to heart failure and kidney disease.

The patient will provide informed consent, confirming their understanding and agreement to participate in the study.

2 initial assessment

The patient will undergo a screening visit to evaluate their current health status, including potassium levels in the blood.

This assessment will determine if the patient is hyperkalemic (high potassium levels) or normokalemic (normal potassium levels).

3 randomization and treatment allocation

The patient will be randomly assigned to one of two groups: one receiving Lokelma (sodium zirconium cyclosilicate) in addition to their regular treatment, and the other continuing with their regular treatment without Lokelma.

Lokelma is administered as an oral suspension, with available dosages of 5 g or 10 g.

4 treatment phase

The patient will follow the prescribed treatment plan for a duration of three months.

During this period, the patient will take Lokelma as directed, alongside their regular medication regimen, which includes RAASi (renin-angiotensin-aldosterone system inhibitors).

5 follow-up visits

The patient will attend regular follow-up visits to monitor their health status and adjust treatment as necessary.

These visits will include assessments of potassium levels, heart function, and kidney function.

6 final assessment

At the end of the three-month treatment period, the patient will undergo a final assessment to evaluate the effectiveness of the treatment.

The primary goal is to determine if there has been an increase in the dosage of RAASi medications by at least 25%.

Who Can Join the Study?

  • The patient must be able to give signed informed consent, which means they understand and agree to the study’s requirements and restrictions.
  • The patient must have high potassium levels in the blood, known as hyperkalemia (between 5.1 and 5.9 mmol/L), or normal potassium levels.
  • The patient must provide informed consent before any study-specific procedures, tests, or analyses are done.
  • The patient must be 70 years of age or older at the time of signing the informed consent form.
  • The patient must have a confirmed diagnosis of Heart Failure (HF), which is a condition where the heart doesn’t pump blood as well as it should. This should be according to clinical practice guidelines and classified as NYHA functional class I-III, which describes the severity of symptoms.
  • The patient must have been previously admitted to the hospital due to worsening heart failure that required treatment with intravenous diuretics, which are medications that help remove excess fluid from the body.
  • The patient must have been stable for at least 24-48 hours after their heart failure worsened before being randomly assigned to a treatment group in the study.
  • The patient must have a confirmed diagnosis of Chronic Kidney Disease (CKD), which means the kidneys are not working as well as they should. This is defined as having a kidney function measurement called eGFR less than 60 ml/min/1.73 m².
  • The patient must be receiving standard care for heart failure and treated according to international guidelines. This includes treatment with RAASi (a type of medication that helps manage heart failure) and/or MRA (another type of medication), and they should have been stable on these treatments for at least 4 weeks at the highest doses they can tolerate.
  • The patient must be on RAASi blocker treatment at a dose that is less than or equal to 75% of the maximum recommended dose.

Who Cannot Join the Study?

  • Patients with severe heart failure, which is a condition where the heart doesn’t pump blood as well as it should, classified as NYHA IV.
  • Patients who are on dialysis, a treatment that filters and purifies the blood using a machine, for kidney disease.
  • Patients who are under 18 years old.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of severe allergic reactions to the study medication.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital Clinico Universitario De Valencia Valencia Spain
Hospital Universitario Severo Ochoa Leganes Spain
Hospital Universitario Reina Sofía Cordoba Spain
Area De Salud De Burgos Y Soria Burgos Spain
Hjadskdg Uvbxnwyxlnwok Najcyzs Selbax Dhn Pwocjyhu Sulflbr Albacete Spain
Hsthxczc Uamnxqqepbigb Fzgslfsjb Adclfvel Madrid Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.08.2024

Trial locations

Investigated drugs:

Lokelma: This medication is used to help manage high potassium levels in the blood. It works by binding to potassium in the digestive tract, which helps to lower the amount of potassium in the body. In this trial, Lokelma is being used to help patients with heart failure and chronic kidney disease who are at risk of high potassium levels.

RAASi: This stands for Renin-Angiotensin-Aldosterone System inhibitors, a group of medications that help manage heart failure and high blood pressure. They work by relaxing blood vessels and reducing the workload on the heart. In this trial, RAASi is being used to help manage heart failure and chronic kidney disease in elderly patients.

Investigated diseases:

Chronic Heart Failure – Chronic heart failure is a condition where the heart is unable to pump blood effectively to meet the body’s needs. It can lead to symptoms such as fatigue, shortness of breath, and fluid retention. Over time, the heart’s ability to function may worsen, causing more severe symptoms. The condition is often classified into stages based on the severity of symptoms and physical limitations. Management focuses on lifestyle changes and medications to improve heart function and quality of life.

Chronic Kidney Disease (Non-Dialysis) – Chronic kidney disease is a gradual loss of kidney function over time. In the non-dialysis stage, the kidneys are still functioning but not as efficiently as they should. This can lead to a buildup of waste products in the blood, causing symptoms like fatigue, swelling, and changes in urination. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function. Monitoring and managing risk factors are crucial to slowing the progression.

Trial ID:
2024-513971-42-00
Protocol code:
SENEKA
Trial Phase:
Therapeutic confirmatory (Phase III)

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