Hypertension ArterialNCT07178964
POTASSIUM-RICH SALT SUBSTITUTES IN KIDNEY TRANSPLANT RECIPIENTS
A study testing Potassium-enriched salt-substitute and Regular table salt in people with Hypertension Arterial and Kidney Transplant, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Excessive sodium intake and inadequate potassium intake in the diet are known risk factors for the development of arterial hypertension and an increased risk of cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension Arterial, Kidney Transplant
- What is being tested?
- Potassium-enriched salt-substitute and Regular table salt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Oct 2025to 30 Sep 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a transplanted kidney ≥ 3 months post kidney-transplant
- a functioning transplanted kidney with estimated glomerular filtration rate (eGFR) according to CKD/EPI equation of at least 25 ml/min
- Elevated blood pressure/hypertension at the time of examination at the Kidney Transplantation Center outpatient clinic, determined by standardized blood pressure measurement (RR ≥ 130/80 mmHg)
- Age ≥ 18 years
Who cannot join
- eGFR according to CKD/EPI equation below 25 ml/min
- serum potassium > 5 mmol/l
- history of unexplained hyperkalemia
- pregnancy or planning of pregnancy
- inability to provide informed consent or to participate in the study (mental retardation, psychiatric illness in an uncontrolled phase)
- multiple organ transplantation
- Consuming most of daily meals outside the home environment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
University Medical Centre Ljubljana
Ljubljana, 1000
Miha Arnol, Professor, MD, PhD, FEBTM, +386 1 522 8977, +38615225214, miha.arnol@kclj.si
Tanja Belcic Mikic, MD, PhD, FEBTM
About this study
Official title: THE USE OF POTASSIUM-RICH SALT SUBSTITUTES IN BLOOD PRESSURE CONTROL OF KIDNEY TRANSPLANT RECIPIENTS
Excessive sodium intake and inadequate potassium intake in the diet are known risk factors for the development of arterial hypertension and an increased risk of cardiovascular events. Data from randomized controlled trials show that the use of salt substitutes with reduced sodium and increased potassium content represent an effective way to reduce dietary sodium intake, blood pressure and the occurrence of cardiovascular events. Patients adhere well to the use of salt substitutes as they do not have to change their daily cooking and seasoning habits and the taste is comparable to that of regular salt. The World Health Organization (WHO) also suggests the use of salt substitutes as an acceptable strategy for reducing dietary salt intake and thus lowering blood pressure and the burden of cardiovascular disease. Recommendations for the use of salt substitutes are not uniform, primarily because of the potential risk of adverse events with increased potassium intake in some individuals, such as patients with advanced chronic kidney disease (CKD), patients receiving potassium-sparing diuretics, and patients receiving potassium supplements.
Nephrology guidelines rarely comment on the use of potassium-rich salt substitutes or discourage their use in patients with advanced stage 4 and 5 CKD, with the exception of Chinese guidelines, which mention the use of potassium-rich salt substitutes in CKD patients not on dialysis depending on serum potassium levels. CKD patients have largely been excluded from clinical trials of potassium-rich salt substitutes, so there is insufficient data on their safety and efficacy in CKD patients.
Read more
In this randomized controlled trial, we will investigate the effects of using potassium-enriched salt substitutes on blood pressure control and serum potassium levels in kidney transplant recipients. In the intervention group, patients will use potassium-enriched salt substitutes at home in a ratio of 75% sodium chloride and 25% potassium chloride instead of regular table salt (100% sodium chloride) for cooking and seasoning food. In the control group, patients will use regular salt at home for cooking and seasoning food. The intervention and control groups will each include 40 to 50 patients who will be monitored for 12 weeks. The study's main focus will be the change in serum potassium and blood pressure before and after the intervention.
We expect to confirm the positive effects of potassium-enriched salt substitutes on blood pressure in kidney transplant recipients without causing undesirable hyperkalemia.
Read the detailed description
Cardiovascular disease is the leading cause of morbidity and mortality worldwide, especially in patients with chronic kidney disease and kidney transplantation. Arterial hypertension is one of the most important risk factors for the occurrence of cardiovascular diseases. Despite advances in modern medicine, the treatment of arterial hypertension is often a major challenge, partly due to patients' poor adherence to medication and lifestyle changes, including adherence to dietary recommendations.
In addition to a reduced sodium intake, an increased potassium intake also plays an important role in lowering blood pressure. The mechanism of increased sodium intake in the development of high blood pressure is probably related to the inability of the kidneys to excrete excess sodium. Potassium deficiency leads to additional sodium retention as it stimulates the activation of the sympathetic nervous system and the renin-angiotensin-aldosterone system. Conversely, an increased potassium intake has the effect of reducing salt sensitivity. Increased potassium intake inhibits the phosphorylation of the NaCl cotransporter and simultaneously reduces sodium reabsorption in the proximal tubule and/or in the ascending limb of the loop of Henle.
Numerous epidemiological studies have shown an inverse relationship between potassium intake and blood pressure. The large international INTERSALT study showed that systolic blood pressure falls by an average of 2 to 3 mmHg when potassium intake is increased by 30 to 45 mmol/day. Reducing sodium intake and increasing potassium intake is likely to be an effective measure for treating arterial hypertension and cardiovascular disease in the population.
Recommendations for the use of salt substitutes to lower blood pressure and prevent cardiovascular disease are not uniform, primarily because of the potential risk of adverse events (especially hyperkalemia) with increased potassium intake in certain individuals such as patients with advanced chronic kidney disease (CKD), patients receiving potassium-sparing diuretics and patients receiving potassium supplements.
Nephrology guidelines rarely mention the use of potassium-rich salt substitutes or advise against it in patients with advanced CKD stages 4 and 5, with the exception of Chinese guidelines, which mention the use of potassium-enriched salt substitutes in non-dialysis CKD patients, depending on the serum potassium level. CKD patients have been mostly excluded from clinical studies of the use of potassium-enriched salt substitutes, so there is not enough data available for CKD patients on the safety and efficacy of potassium-enriched salt substitutes.
A review of the literature suggests that different sources of potassium (diet or potassium supplements) have different effects on serum potassium levels in patients with CKD. The effect of potassium-enriched salt substitutes on serum potassium levels in renal patients is unknown. A study is currently underway in the United States to study the effect of salt substitutes on serum potassium and blood pressure in hemodialysis patients. Since this is a population of patients at increased risk for hyperkalemia, the primary goal is safety, namely the detection of hyperkalemia.
In this randomized single-blind controlled trial, we want to examine the effect of using potassium-enriched salt substitutes on serum potassium and blood pressure in kidney transplant patients with hypertension. In the intervention group, patients will use potassium-enriched salt substitutes at home in a ratio of 75% sodium chloride and 25% potassium chloride instead of regular table salt for cooking and seasoning food. In the control group, patients will use table salt (100% sodium chloride) at home for cooking and seasoning food. Potassium-enriched salt substitutes and 100% sodium chloride will be prepared for patients in the hospital pharmacy. During the study, we will not introduce new antihypertensive medications or medications that affect serum potassium. If the patient is receiving potassium supplements before inclusion in the study, they will be discontinued at least a week before the start of the study. Before the start of the intervention, we will measure the patients' body composition and check the patients' dietary habits using a questionnaire. After the intervention, the patients will report any changes in the taste of home-cooked food.
The main purpose of the study is:
- to show that the use of salt substitutes in kidney transplant patients does not lead to a significantly increased risk of hyperkalemia.
- to show that the use of salt substitutes in kidney transplant recipients has an effect on lowering blood pressure and is thus a safe and effective measure in the management of arterial hypertension in this population.
We expect a mild effect on blood pressure reduction in kidney transplant recipients with no significant increased risk of hyperkalemia.
- Conditions
- Hypertension Arterial, Kidney Transplant
- Being tested
- Potassium-enriched salt-substitute, Regular table salt
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium-enriched salt-substituteOther
The patients in the experimental group will use potassium-enriched salt-substitutes for cooking and seasoning food in their home environment. Potassium-enriched salt-substitutes will contain 25% potassium chloride nad 75% sodium chloride.
Regular table saltOther
Patients in this arm will use regular table salt (100 % sodium chloride) for cooking and seasoning food in their home environment.
| Study group | Role | What they receive |
|---|---|---|
| Potassium-enriched salt-substitute arm | Experimental | The patients in this arm will use potassium-enriched salt-substitutes for cooking and seasoning food in their home environment. Receives: Other: Potassium-enriched salt-substitute |
| Regular table salt arm | Sham comparator | The patients in this arm will use regular table salt for cooking and seasoning food in their home environment. Receives: Other: Regular table salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperkalemia
Change in serum potassium in mmol/l after using potassium-enriched salt-substitutes for cooking and seasoning food at home for 12 weeks
Measured: 12 weeks.
Secondary outcomes (11)
Change in systolic blood pressure
Change in systolic blood pressure in mmHg measured with standardized office blood-pressure measurement
Measured: 12 weeks
Change in diastolic blood pressure
Change in diastolic blood pressure in mmHg measured with standardized office blood pressure measurement
Measured: 12 weeks
Change in average systolic 24-hour blood pressure
Change in average 24-hour systolic blood pressure measured by 24-hour blood pressure monitoring device
Measured: 12 weeks
Change in average diastolic 24-hour blood pressure
Change in average 24-hour diastolic blood pressure measured by 24-hour blood pressure monitoring device
Measured: 12 weeks
Change in average daily systolic blood pressure
Change in average daily systolic blood pressure measured by 24-hour blood pressure monitoring device
Measured: 12 weeks
Change in average daily diastolic blood pressure
Change in average daily diastolic blood pressure measured by 24-hour blood pressure monitoring device
Measured: 12 weeks
Change in average night systolic blood pressure
Change in average night systolic blood pressure measured by 24-hour blood pressure monitoring device
Measured: 12 weeks
Change in average night diastolic blood pressure
Change in average diastolic night blood pressure measured by 24-hour blood pressure measuring device
Measured: 12 weeks
Reduction in the number or dose of antihypertensive drugs
A reduction in the number or dose of used antihypertensive drugs to achieve target blood pressure
Measured: 12 weeks
Change in the urine sodium/potassium ratio
Change in the ratio of sodium to potassium excreted in urine, based on measurements of 24-hour urine collection
Measured: 12 weeks
Change in taste of food
Patients will report on change of the taste of food (YES/NO)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hypertension ArterialStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanja Belčič Mikič, University Medical Centre Ljubljana
- Investigators
- Tanja Belcic Mikic, MD, PhD, FEBTM, Principal investigator, University Medical Centre LjubljanaMiha Arnol, Professor, MD, PhD, FEBTM, Study director, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178964
- Sponsor's protocol ID
- 20250138
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon request from the principal investigator in an anonymized form.
Publications
Chia YC, He FJ, Cheng MH, Shin J, Cheng HM, Sukonthasarn A, Wang TD, Van Huynh M, Buranakitjaroen P, Sison J, Siddique S, Turana Y, Verma N, Tay JC, Schlaich MP, Wang JG, Kario K; HOPE-Asia Network. Role of dietary potassium and salt substitution in the prevention and management of hypertension. Hypertens Res. 2025 Jan;48(1):301-313. doi: 10.1038/s41440-024-01862-w. Epub 2024 Oct 29.
PubMed 39472546Romero-Gonzalez G, Rodriguez-Chitiva N, Canameras C, Paul-Martinez J, Urrutia-Jou M, Troya M, Soler-Majoral J, Graterol Torres F, Sanchez-Baya M, Calabia J, Bover J. Albuminuria, Forgotten No More: Underlining the Emerging Role in CardioRenal Crosstalk. J Clin Med. 2024 Jan 29;13(3):777. doi: 10.3390/jcm13030777.
PubMed 38337471Xu X, Zeng L, Jha V, Cobb LK, Shibuya K, Appel LJ, Neal B, Schutte AE. Potassium-Enriched Salt Substitutes: A Review of Recommendations in Clinical Management Guidelines. Hypertension. 2024 Mar;81(3):400-414. doi: 10.1161/HYPERTENSIONAHA.123.21343. Epub 2024 Jan 29.
PubMed 38284271Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
PubMed 39082471Visser WJ, Gritter M, Hoorn EJ. Dietary Potassium in Chronic Kidney Disease: Do Not Restrict the Evidence. J Ren Nutr. 2021 Nov;31(6):552-553. doi: 10.1053/j.jrn.2020.12.012. Epub 2021 Mar 12. No abstract available.
PubMed 33715954Daneshzad E, Hatami SE, Sobhani S, Ghoreshi B, Khonsari NM, Shahrestanaki E, Pezeshki M, Kiaee ZF, Assar O, Qorbani M. Effects of potassium-enriched salt substitutes on blood pressure in Iranian hypertensive patients: the protocol for a randomised, double-blind controlled trial. BMJ Open. 2025 Jun 25;15(6):e090472. doi: 10.1136/bmjopen-2024-090472.
PubMed 40562554Tsai YC, Tsao YP, Huang CJ, Tai YH, Su YC, Chiang CE, Sung SH, Chen CH, Cheng HM. Effectiveness of salt substitute on cardiovascular outcomes: A systematic review and meta-analysis. J Clin Hypertens (Greenwich). 2022 Sep;24(9):1147-1160. doi: 10.1111/jch.14562.
PubMed 36196475Bernabe-Ortiz A, Sal Y Rosas VG, Ponce-Lucero V, Cardenas MK, Carrillo-Larco RM, Diez-Canseco F, Pesantes MA, Sacksteder KA, Gilman RH, Miranda JJ. Effect of salt substitution on community-wide blood pressure and hypertension incidence. Nat Med. 2020 Mar;26(3):374-378. doi: 10.1038/s41591-020-0754-2. Epub 2020 Feb 17.
PubMed 32066973Eleftheriadis G, Naik MG, Osmanodja B, Halleck F, Schrezenmeier E, Liefeldt L, Choi M, Bachmann F, Avaniadi DP, von Hoerschelmann E, Lucht C, Zaks M, Duettmann W, Budde K. Office or home versus 24-h blood pressure measurement in stable kidney transplant recipients. Nephrol Dial Transplant. 2024 Oct 30;39(11):1890-1899. doi: 10.1093/ndt/gfae076.
PubMed 38549427Tantisattamo E, Molnar MZ, Ho BT, Reddy UG, Dafoe DC, Ichii H, Ferrey AJ, Hanna RM, Kalantar-Zadeh K, Amin A. Approach and Management of Hypertension After Kidney Transplantation. Front Med (Lausanne). 2020 Jun 16;7:229. doi: 10.3389/fmed.2020.00229. eCollection 2020.
PubMed 32613001Speer C, Benning L, Morath C, Zeier M, Frey N, Opelz G, Dohler B, Tran TH; Collaborative Transplant Study. Blood Pressure Goals and Outcomes in Kidney Transplant Recipients in an Analysis of the Collaborative Transplant Study. Kidney Int Rep. 2024 Dec 6;10(3):780-790. doi: 10.1016/j.ekir.2024.12.004. eCollection 2025 Mar.
PubMed 40225383
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE USE OF POTASSIUM-RICH SALT SUBSTITUTES IN BLOOD PRESSURE CONTROL OF KIDNEY TRANSPLANT RECIPIENTS
- ClinicalTrials.gov ID
- NCT07178964
- Acronym / sponsor ID
- 20250138
- Conditions
- Hypertension Arterial, Kidney Transplant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Sep 2025 (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.
Excessive sodium intake and inadequate potassium intake in the diet are known risk factors for the development of arterial hypertension and an increased risk of cardiovascular events. Data from randomized controlled trials show that the use of salt substitutes with reduced sodium and increased potassium content represent an effective way to reduce dietary sodium intake, blood pressure and the occurrence of cardiovascular events. Patients adhere well to the use of salt substitutes as they do not have to change their daily cooking and seasoning habits and the taste is comparable to that of regular salt. The World Health Organization (WHO) also suggests the use of salt substitutes as an acceptable strategy for reducing dietary salt intake and thus lowering blood pressure and the burden of cardiovascular disease. Recommendations for the use of salt substitutes are not uniform, primarily because of the potential risk of adverse events with increased potassium intake in some individuals, such as patients with advanced chronic kidney disease (CKD), patients receiving potassium-sparing diuretics, and patients receiving potassium supplements.
Nephrology guidelines rarely comment on the use of potassium-rich salt substitutes or discourage their use in patients with advanced stage 4 and 5 CKD, with the exception of Chinese guidelines, which mention the use of potassium-rich salt substitutes in CKD patients not on dialysis depending on serum potassium levels. CKD patients have largely been excluded from clinical trials of potassium-rich salt substitutes, so there is insufficient data on their safety and efficacy in CKD patients.
In this randomized controlled trial, we will investigate the effects of using potassium-enriched salt substitutes on blood pressure control and serum potassium levels in kidney transplant recipients. In the intervention group, patients will use potassium-enriched salt substitutes at home in a ratio of 75% sodium chloride and 25% potassium chloride instead of regular table salt (100% sodium chloride) for cooking and seasoning food. In the control group, patients will use regular salt at home for cooking and seasoning food. The intervention and control groups will each include 40 to 50 patients who will be monitored for 12 weeks. The study's main focus will be the change in serum potassium and blood pressure before and after the intervention.
We expect to confirm the positive effects of potassium-enriched salt substitutes on blood pressure in kidney transplant recipients without causing undesirable hyperkalemia.
Detailed description
Cardiovascular disease is the leading cause of morbidity and mortality worldwide, especially in patients with chronic kidney disease and kidney transplantation. Arterial hypertension is one of the most important risk factors for the occurrence of cardiovascular diseases. Despite advances in modern medicine, the treatment of arterial hypertension is often a major challenge, partly due to patients' poor adherence to medication and lifestyle changes, including adherence to dietary recommendations.
In addition to a reduced sodium intake, an increased potassium intake also plays an important role in lowering blood pressure. The mechanism of increased sodium intake in the development of high blood pressure is probably related to the inability of the kidneys to excrete excess sodium. Potassium deficiency leads to additional sodium retention as it stimulates the activation of the sympathetic nervous system and the renin-angiotensin-aldosterone system. Conversely, an increased potassium intake has the effect of reducing salt sensitivity. Increased potassium intake inhibits the phosphorylation of the NaCl cotransporter and simultaneously reduces sodium reabsorption in the proximal tubule and/or in the ascending limb of the loop of Henle.
Numerous epidemiological studies have shown an inverse relationship between potassium intake and blood pressure. The large international INTERSALT study showed that systolic blood pressure falls by an average of 2 to 3 mmHg when potassium intake is increased by 30 to 45 mmol/day. Reducing sodium intake and increasing potassium intake is likely to be an effective measure for treating arterial hypertension and cardiovascular disease in the population.
Recommendations for the use of salt substitutes to lower blood pressure and prevent cardiovascular disease are not uniform, primarily because of the potential risk of adverse events (especially hyperkalemia) with increased potassium intake in certain individuals such as patients with advanced chronic kidney disease (CKD), patients receiving potassium-sparing diuretics and patients receiving potassium supplements.
Nephrology guidelines rarely mention the use of potassium-rich salt substitutes or advise against it in patients with advanced CKD stages 4 and 5, with the exception of Chinese guidelines, which mention the use of potassium-enriched salt substitutes in non-dialysis CKD patients, depending on the serum potassium level. CKD patients have been mostly excluded from clinical studies of the use of potassium-enriched salt substitutes, so there is not enough data available for CKD patients on the safety and efficacy of potassium-enriched salt substitutes.
A review of the literature suggests that different sources of potassium (diet or potassium supplements) have different effects on serum potassium levels in patients with CKD. The effect of potassium-enriched salt substitutes on serum potassium levels in renal patients is unknown. A study is currently underway in the United States to study the effect of salt substitutes on serum potassium and blood pressure in hemodialysis patients. Since this is a population of patients at increased risk for hyperkalemia, the primary goal is safety, namely the detection of hyperkalemia.
In this randomized single-blind controlled trial, we want to examine the effect of using potassium-enriched salt substitutes on serum potassium and blood pressure in kidney transplant patients with hypertension. In the intervention group, patients will use potassium-enriched salt substitutes at home in a ratio of 75% sodium chloride and 25% potassium chloride instead of regular table salt for cooking and seasoning food. In the control group, patients will use table salt (100% sodium chloride) at home for cooking and seasoning food. Potassium-enriched salt substitutes and 100% sodium chloride will be prepared for patients in the hospital pharmacy. During the study, we will not introduce new antihypertensive medications or medications that affect serum potassium. If the patient is receiving potassium supplements before inclusion in the study, they will be discontinued at least a week before the start of the study. Before the start of the intervention, we will measure the patients' body composition and check the patients' dietary habits using a questionnaire. After the intervention, the patients will report any changes in the taste of home-cooked food.
The main purpose of the study is:
- to show that the use of salt substitutes in kidney transplant patients does not lead to a significantly increased risk of hyperkalemia.
- to show that the use of salt substitutes in kidney transplant recipients has an effect on lowering blood pressure and is thus a safe and effective measure in the management of arterial hypertension in this population.
We expect a mild effect on blood pressure reduction in kidney transplant recipients with no significant increased risk of hyperkalemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium-enriched salt-substitute arm | Experimental | Other: Potassium-enriched salt-substituteThe patients in this arm will use potassium-enriched salt-substitutes for cooking and seasoning food in their home environment. |
| Regular table salt arm | Sham comparator | Other: Regular table saltThe patients in this arm will use regular table salt for cooking and seasoning food in their home environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with a transplanted kidney ≥ 3 months post kidney-transplant
- a functioning transplanted kidney with estimated glomerular filtration rate (eGFR) according to CKD/EPI equation of at least 25 ml/min
- Elevated blood pressure/hypertension at the time of examination at the Kidney Transplantation Center outpatient clinic, determined by standardized blood pressure measurement (RR ≥ 130/80 mmHg)
- Age ≥ 18 years
Key exclusion criteria (7 listed)
- eGFR according to CKD/EPI equation below 25 ml/min
- serum potassium > 5 mmol/l
- history of unexplained hyperkalemia
- pregnancy or planning of pregnancy
- inability to provide informed consent or to participate in the study (mental retardation, psychiatric illness in an uncontrolled phase)
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 |
|---|---|---|
| Potassium-enriched salt-substituteThe patients in the experimental group will use potassium-enriched salt-substitutes for cooking and seasoning food in their home environment. Potassium-enriched salt-substitutes will contain 25% potassium chloride nad 75% sodium chloride. | Other | Potassium-enriched salt-substitute arm |
| Regular table saltPatients in this arm will use regular table salt (100 % sodium chloride) for cooking and seasoning food in their home environment. | Other | Regular table salt arm |
Primary outcome
Hyperkalemia
Time frame: 12 weeks.
Change in serum potassium in mmol/l after using potassium-enriched salt-substitutes for cooking and seasoning food at home for 12 weeks
11 secondary outcomes
Change in systolic blood pressure
Time frame: 12 weeks
Change in diastolic blood pressure
Time frame: 12 weeks
Change in average systolic 24-hour blood pressure
Time frame: 12 weeks
Change in average diastolic 24-hour blood pressure
Time frame: 12 weeks
Change in average daily systolic blood pressure
Time frame: 12 weeks
Change in average daily diastolic blood pressure
Time frame: 12 weeks
Change in average night systolic blood pressure
Time frame: 12 weeks
Change in average night diastolic blood pressure
Time frame: 12 weeks
Reduction in the number or dose of antihypertensive drugs
Time frame: 12 weeks
Change in the urine sodium/potassium ratio
Time frame: 12 weeks
Change in taste of food
Time frame: 12 weeks
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 17 Sep 2025.
- Background: PubMed 39472546Chia YC, He FJ, Cheng MH, Shin J, Cheng HM, Sukonthasarn A, Wang TD, Van Huynh M, Buranakitjaroen P, Sison J, Siddique S, Turana Y, Verma N, Tay JC, Schlaich MP, Wang JG, Kario K; HOPE-Asia Network. Role of dietary potassium and salt substitution in the prevention and management of hypertension. Hypertens Res. 2025 Jan;48(1):301-313. doi: 10.1038/s41440-024-01862-w. Epub 2024 Oct 29.
- Background: PubMed 38337471Romero-Gonzalez G, Rodriguez-Chitiva N, Canameras C, Paul-Martinez J, Urrutia-Jou M, Troya M, Soler-Majoral J, Graterol Torres F, Sanchez-Baya M, Calabia J, Bover J. Albuminuria, Forgotten No More: Underlining the Emerging Role in CardioRenal Crosstalk. J Clin Med. 2024 Jan 29;13(3):777. doi: 10.3390/jcm13030777.
- Background: PubMed 38284271Xu X, Zeng L, Jha V, Cobb LK, Shibuya K, Appel LJ, Neal B, Schutte AE. Potassium-Enriched Salt Substitutes: A Review of Recommendations in Clinical Management Guidelines. Hypertension. 2024 Mar;81(3):400-414. doi: 10.1161/HYPERTENSIONAHA.123.21343. Epub 2024 Jan 29.
- Background: PubMed 39082471Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
- Background: PubMed 33715954Visser WJ, Gritter M, Hoorn EJ. Dietary Potassium in Chronic Kidney Disease: Do Not Restrict the Evidence. J Ren Nutr. 2021 Nov;31(6):552-553. doi: 10.1053/j.jrn.2020.12.012. Epub 2021 Mar 12. No abstract available.
- Background: PubMed 40562554Daneshzad E, Hatami SE, Sobhani S, Ghoreshi B, Khonsari NM, Shahrestanaki E, Pezeshki M, Kiaee ZF, Assar O, Qorbani M. Effects of potassium-enriched salt substitutes on blood pressure in Iranian hypertensive patients: the protocol for a randomised, double-blind controlled trial. BMJ Open. 2025 Jun 25;15(6):e090472. doi: 10.1136/bmjopen-2024-090472.
- Background: PubMed 36196475Tsai YC, Tsao YP, Huang CJ, Tai YH, Su YC, Chiang CE, Sung SH, Chen CH, Cheng HM. Effectiveness of salt substitute on cardiovascular outcomes: A systematic review and meta-analysis. J Clin Hypertens (Greenwich). 2022 Sep;24(9):1147-1160. doi: 10.1111/jch.14562.
- Background: PubMed 32066973Bernabe-Ortiz A, Sal Y Rosas VG, Ponce-Lucero V, Cardenas MK, Carrillo-Larco RM, Diez-Canseco F, Pesantes MA, Sacksteder KA, Gilman RH, Miranda JJ. Effect of salt substitution on community-wide blood pressure and hypertension incidence. Nat Med. 2020 Mar;26(3):374-378. doi: 10.1038/s41591-020-0754-2. Epub 2020 Feb 17.
- Background: PubMed 38549427Eleftheriadis G, Naik MG, Osmanodja B, Halleck F, Schrezenmeier E, Liefeldt L, Choi M, Bachmann F, Avaniadi DP, von Hoerschelmann E, Lucht C, Zaks M, Duettmann W, Budde K. Office or home versus 24-h blood pressure measurement in stable kidney transplant recipients. Nephrol Dial Transplant. 2024 Oct 30;39(11):1890-1899. doi: 10.1093/ndt/gfae076.
- Background: PubMed 32613001Tantisattamo E, Molnar MZ, Ho BT, Reddy UG, Dafoe DC, Ichii H, Ferrey AJ, Hanna RM, Kalantar-Zadeh K, Amin A. Approach and Management of Hypertension After Kidney Transplantation. Front Med (Lausanne). 2020 Jun 16;7:229. doi: 10.3389/fmed.2020.00229. eCollection 2020.
- Background: PubMed 40225383Speer C, Benning L, Morath C, Zeier M, Frey N, Opelz G, Dohler B, Tran TH; Collaborative Transplant Study. Blood Pressure Goals and Outcomes in Kidney Transplant Recipients in an Analysis of the Collaborative Transplant Study. Kidney Int Rep. 2024 Dec 6;10(3):780-790. doi: 10.1016/j.ekir.2024.12.004. eCollection 2025 Mar.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon request from the principal investigator in an anonymized form.
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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.
Tanja Belcic Mikic, MD, PhD, FEBTM principal investigator
University Medical Centre Ljubljana
Miha Arnol, Professor, MD, PhD, FEBTM study director
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potassium-enriched salt-substitute and Regular table salt in people with Hypertension Arterial and Kidney Transplant, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Tanja Belcic Mikic, MD, PhD, FEBTM (+386 1 522 2751, tanja.belcic.mikic@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperkalemia (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07178964, which also lists 11 linked publications.
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 17 Sep 2025.