Potassium binder may unlock lifesaving heart drugs for seniors
NCT ID NCT06578078
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a potassium-lowering drug called sodium zirconium cyclosilicate (Lokelma) can help elderly patients with heart failure and chronic kidney disease safely take higher doses of RAASi medications, which are often limited by high potassium levels. The trial will enroll 94 people aged 70 and older, comparing those who get Lokelma plus standard RAASi therapy to those who get standard care alone. The main goal is to see if more patients can increase their RAASi dose by at least 25% over three months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sodium Zirconium Cyclosilicate (Lokelma)
- What this could lead to
- If successful, this could show a way to safely use life-saving heart and kidney medications in elderly patients who currently cannot due to high potassium levels.
- What could go wrong
- This is a small, early-phase trial (94 participants) focused on medication dosing, not hard outcomes like survival. The drug may not meaningfully improve long-term health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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70 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 at maximum tolerated doses. * 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 sK+ ≥4.5 mEq/L ≤ 5.1 mEq/L at inclusion Exclusion Criteria: * 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. Subjects 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 disease or other causes of hypoaldosteronism. * 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 calcium (Veltassa®) within 7 days prior to the first dose of study drug. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Clínico Universitario de Valencia
RECRUITINGValencia, 46010, Spain
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Hospital Universitario Fundación Alcorcón
NOT_YET_RECRUITINGAlcorcón, Madrid, 28922, Spain
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Hospital Universitario Nuestra Señora del Perpétuo Socorro
RECRUITINGAlbacete, 02006, Spain
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Hospital Universitario Reina Sofía
NOT_YET_RECRUITINGCórdoba, 14004, Spain
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Hospital Universitario Severo Ochoa
NOT_YET_RECRUITINGLeganés, Madrid, 28914, Spain
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Hospital Universitario de Burgos
RECRUITINGBurgos, 09006, Spain
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