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New treatment option for Heart Failure
Official title A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
ClinicalTrials.gov ID: NCT06578078
What this study is testing
What is Sodium Zirconium Cyclosilicate?
Sodium Zirconium Cyclosilicate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for heart failure.
Also referred to as Lokelma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Heart failure (HF) and Chronic Kidney Disease (CKD) patients are frequently not administered renin-angiotensin aldosterone system inhibitor (RAASi) therapies at recommended doses due to hyperkalaemia, despite proven mortality and morbidity benefits. Sodium zirconium cyclosilicate (SZC) is a nonabsorbed potassium binder proven to lower serum potassium (S-K) and maintain normokalaemia.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
- Provision of informed consent form prior to any study specific procedures, sampling and analysis.
- Individuals must be ≥ 70 years of age at the time of signing the informed consent form.
- Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF...
- Individuals must have previously been admitted to hospital due to HF decompensation requiring intravenous diuretics.
You likely can't join if
- Limited life expectancy (less than 1 year) according to clinician's criteria, such as but not limited to malignancy, with life expectancy of less...
- sK \>6 mEq/litre or \<4.5mEq/litre or history of hypokalemic episodes (S-K\<3.5 mEq/L) during the last year.
- Patients on haemodialysis or haemofiltration
- NYHA functional class IV
- Patients undergoing treatment with potassium binders.
- Active tumour undergoing chemotherapy or metastasis or malignancy requiring treatment.
See the full eligibility criteria
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Provision of informed consent form prior to any study specific procedures, sampling and analysis.
- Individuals must be ≥ 70 years of age at the time of signing the informed consent form.
- Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).
- Individuals must have previously been admitted to hospital due to HF decompensation requiring intravenous diuretics.
- Individuals must have been stabilised for at least 24-48h of their HF decompensation before randomisation.
- Individuals must have a confirmed diagnosis of Chronic Kidney Disease defined as a renal impairment of eGFR less than 60ml/min/1.73 m2.
- Individuals receiving background standard of care for HF and treated according to international guidelines. Specific treatment should include RAASi and/or MRA treatment and at least should have been stable for ≥ 4 weeks...
- Patients on RAASi blocker treatment with less than or equal to 75% of the maximum recommended dose.
- Hyperkalemic patients (sK+ 5.1-5.9 mmol/L at screening / study enrolment) or Normokalemic patients at risk of developing HK defining as having a history of hyperkalaemia (sK+ \>5.0 mEq/L) within the prior 24 months and...
- Limited life expectancy (less than 1 year) according to clinician's criteria, such as but not limited to malignancy, with life expectancy of less than 2 years based on investigator's clinical judgement.
- sK \>6 mEq/litre or \<4.5mEq/litre or history of hypokalemic episodes (S-K\<3.5 mEq/L) during the last year.
- Patients on haemodialysis or haemofiltration
- NYHA functional class IV
- Patients undergoing treatment with potassium binders.
- Active tumour undergoing chemotherapy or metastasis or malignancy requiring treatment.
- Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. people with atrial fibrillation controlled by medication are permitted.
- QTc(f) \> 550 msec.
- History of QT prolongation associated with other medications that required discontinuation of that medication.
- Congenital long QT syndrome.
- Prior history of hypersensitivity to a RAAS blocker drug, including but not limited to development of angioedema, icterus, hepatitis, or neutropenia or thrombocytopenia requiring treatment modification. Addison's...
- Patients with a known hypersensitivity to SZC or any of the excipients of the product.
- Individuals treated with potassium binding resins such as sodium polystyrene sulfonate (SPS, e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex...
- Treated with potassium supplements within 7 days prior to randomization. 15. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.
- Known to have tested positive for human immunodeficiency virus.
- Known history of drug or alcohol abuse within 3 year of screening.
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
- Previous enrolment in the present study.
- Participation in another clinical study with an investigational product during the last 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Alcorcón, Madrid, Spain
- Leganés, Madrid, Spain
- Albacete, Spain
- Burgos, Spain
- Córdoba, Spain
- Valencia, Spain
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alcorcón, Madrid, Spain; Leganés, Madrid, Spain; Albacete, Spain; Burgos, Spain; Córdoba, Spain; Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.