Heart FailurePhase 3SENEKANCT06578078
A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
A Phase 3 study testing Sodium Zirconium Cyclosilicate in people with Heart Failure and Chronic Kidney Diseases, run by Fundación para la Investigación del Hospital Clínico de Valencia at 6 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Heart Failure, Chronic Kidney Diseases
- What is being tested?
- Sodium Zirconium Cyclosilicate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 6 sitesSpain
- Study dates
- 3 Oct 2024to 30 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitario Nuestra Señora del Perpétuo Socorro
Albacete, 02006
Alicia Noguerón García, Alicia_10nogueron@hotmail.com
- Not yet recruiting
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Carolina Ortiz Cortés, carol.ortizcortes@gmail.com
- Recruiting
Hospital Universitario de Burgos
Burgos, 09006
Maria Jesus Izquierdo Ortiz, mjizquierdo3@hotmail.com
- Not yet recruiting
Hospital Universitario Reina Sofía
Córdoba, 14004
Juan Carlos Castillo Dominguez, juanc.castillo.dominguez.sspa@juntadeandalucia.es
- Not yet recruiting
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28914
Esther Alvarez Rodríguez, ealvarezr10@gmail.com
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
Clara Bonanad Lozano, 963156181, clarabonanad@gmail.com
About this study
Official title: A Randomized Clinical Trial to Define the Best Strategy for the Management of Heart Failure and Chronic Kidney Disease Among Elderly Patients With or at High Risk of hyperKalemia in Span by Optimizing the Use of RAASi With SZC
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. The purpose is to assess if a treatment regimen containing SZC will allow RAASi therapies to be optimized to target doses in patients with heart failure, chronic kidney disease and elevated serum potassium or at risk of developing elevated serum potassium.
Read the detailed description
This is a randomized clinical trial, multicentre, parallel group, open label, to evaluate the use of sodium zirconium cyclosilicate (SZC) to optimize RAASi therapy in patients with heart failure and chronic kidney disease, through up-titration of ACEi, ARB, ARNI or MRA therapy according to clinical guidelines (1), without inducing clinically significant hyperkalemia. Eligible subjects will have been admitted to hospital because of an HF (NYHA I- III) decompensation, will have required intravenous diuretics and will have had mild hyperkalaemic values that needed stabilization or be at risk of developing hyperkalaemia. Subjects will be randomised in a 1:1 ratio to receive SZC or none (standard of care treatment without potassium binders) for 3 months while optimizing RAASi therapies according to the European Society of Cardiology (ESC) guidelines.
- Conditions
- Heart Failure, Chronic Kidney Diseases
- Being tested
- Sodium Zirconium Cyclosilicate, Standard of care treatment (RAASi therapy)
- Medical subject headings
- Heart Failure, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Zirconium CyclosilicateDrug
Also called Lokelma
Use of sodium zirconium cyclosilicate to optimize RAASi therapy, through up-titration of ACEi, ARB, ARNI or MRA therapy according to clinical guidelines
Standard of care treatment (RAASi therapy)Drug
Standard of care treatment (RAASi therapy) without use of sodium zirconium cyclosilicate
| Study group | Role | What they receive |
|---|---|---|
| SZC group | Experimental | Sodium zirconium cyclosilicate with standard of care treatment (RAASi therapy) Receives: Drug: Sodium Zirconium Cyclosilicate |
| Control group | Active comparator | Standard of care treatment (RAASi therapy) without Sodium zirconium cyclosilicate Receives: Drug: Standard of care treatment (RAASi therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients increasing at least 25% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9)
To compare the number of patients achieving an increase of at least 25% of RAASi according to guideline-recommended target doses, in the arm treated with Lokelma plus RAASi versus the arm treated with RAASi without K+ binder, at 3 months after study inclusion.
Measured: Through study completion, an average of 3 months
Secondary outcomes (2)
Number of patients achieving at least 50% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9)
To assess the number of patients achieving at least 50% of the target dose of RAASi recommended in the guidelines.
Measured: Through study completion, an average of 3 months
Number of patients increasing 50% of RAASi doses since the screening visit (V0) to 3 months after study inclusion (V9)
To assess the number of patients achieving at least 50% of the target dose of RAASi recommended in the guidelines.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start3 Oct 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised clinical trial, multicentre, open label, of RAASi associated with SZC versus modification of RAASi without added chelator in patients over 70 years of age, who after the stabilization of an acute HF episode and comorbid CKD, have HK or are at high risk of developing HK.
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578078
- Sponsor's protocol ID
- SENEKA
- Other IDs
- 2024-513971-42-00
- Acronym
- SENEKA
- Status last verified
- Mar 2026
- First submitted
- 27 Aug 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Define the Best Strategy for the Management of Heart Failure and Chronic Kidney Disease Among Elderly Patients With or at High Risk of hyperKalemia in Span by Optimizing the Use of RAASi With SZC
- ClinicalTrials.gov ID
- NCT06578078
- Acronym / sponsor ID
- SENEKA / SENEKA
- Conditions
- Heart Failure, Chronic Kidney Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The purpose is to assess if a treatment regimen containing SZC will allow RAASi therapies to be optimized to target doses in patients with heart failure, chronic kidney disease and elevated serum potassium or at risk of developing elevated serum potassium.
Detailed description
This is a randomized clinical trial, multicentre, parallel group, open label, to evaluate the use of sodium zirconium cyclosilicate (SZC) to optimize RAASi therapy in patients with heart failure and chronic kidney disease, through up-titration of ACEi, ARB, ARNI or MRA therapy according to clinical guidelines (1), without inducing clinically significant hyperkalemia. Eligible subjects will have been admitted to hospital because of an HF (NYHA I- III) decompensation, will have required intravenous diuretics and will have had mild hyperkalaemic values that needed stabilization or be at risk of developing hyperkalaemia. Subjects will be randomised in a 1:1 ratio to receive SZC or none (standard of care treatment without potassium binders) for 3 months while optimizing RAASi therapies according to the European Society of Cardiology (ESC) guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomised clinical trial, multicentre, open label, of RAASi associated with SZC versus modification of RAASi without added chelator in patients over 70 years of age, who after the stabilization of an acute HF episode and comorbid CKD, have HK or are at high risk of developing HK.
| Arm | Type | Receives |
|---|---|---|
| SZC group | Experimental | Drug: Sodium Zirconium CyclosilicateSodium zirconium cyclosilicate with standard of care treatment (RAASi therapy) |
| Control group | Active comparator | Drug: Standard of care treatment (RAASi therapy)Standard of care treatment (RAASi therapy) without Sodium zirconium cyclosilicate |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Zirconium CyclosilicateAlso: LokelmaUse of sodium zirconium cyclosilicate to optimize RAASi therapy, through up-titration of ACEi, ARB, ARNI or MRA therapy according to clinical guidelines | Drug | SZC group |
| Standard of care treatment (RAASi therapy)Standard of care treatment (RAASi therapy) without use of sodium zirconium cyclosilicate | Drug | Control group |
Primary outcome
Number of patients increasing at least 25% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9)
Time frame: Through study completion, an average of 3 months
To compare the number of patients achieving an increase of at least 25% of RAASi according to guideline-recommended target doses, in the arm treated with Lokelma plus RAASi versus the arm treated with RAASi without K+ binder, at 3 months after study inclusion.
2 secondary outcomes
Number of patients achieving at least 50% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9)
Time frame: Through study completion, an average of 3 months
Number of patients increasing 50% of RAASi doses since the screening visit (V0) to 3 months after study inclusion (V9)
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Zirconium Cyclosilicate in people with Heart Failure and Chronic Kidney Diseases, run by Fundación para la Investigación del Hospital Clínico de Valencia at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara Bonanad Lozano (+34 963156181, clarabonanad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients increasing at least 25% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9) (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.