HypertensionNCT07460882
The Impact of Low Sodium Salt Substitute Use on Serum Potassium Levels Among Patients With Hypertension
A study testing Low-sodium salt substitute in people with Hypertension, run by Johns Hopkins University at 1 site in Bangladesh.
Trial summary
The goal of this pre-post study is to assess the risk of hyperkalemia in adults with hypertension on medication in Bangladesh. The main questions it aims to answer are: Is the risk of hyperkalemia after the initiation of Low Sodium Salt Substitute (LSSS) in people on antihypertensive medication (especially RASi) large… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Low-sodium salt substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 1 siteBangladesh
- Study dates
- 8 Aug 2026to 30 Sep 2027
- 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
- Adults ≥18 years with clinically diagnosed hypertension treated with medication [on a stable dose at least for 2 months]
- Have a phone for contact
Who cannot join
- Those with baseline K ≥5.0 or K <3.0 mmol/L
- Advanced kidney disease (eGFR <45 ml/min/1.73m2).
- Those on potassium sparing diuretics (e.g., spironolactone)
- Other medical conditions determined by physicians (e.g., heart failure treated with medication; life expectancy less than 12 months)
- Dine out for dinner more than 3 times a week
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sohel Reza Choudhury, MD, PhD contact
Bangladesh1 site, 1 recruiting
- Recruiting
The National Heart Foundation of Bangladesh
Dhaka
Sohel Reza Choudhury, MD, PhD, +880 9666-750075, sohel_r_choudhury@hotmail.com
About this study
The goal of this pre-post study is to assess the risk of hyperkalemia in adults with hypertension on medication in Bangladesh. The main questions it aims to answer are:
Is the risk of hyperkalemia after the initiation of Low Sodium Salt Substitute (LSSS) in people on antihypertensive medication (especially RASi) large enough to be concerned about its broad use in this population?
Does initiation of LSSS correct hypokalemia in people on antihypertensive medication (especially RASi) with low serum potassium levels?
Participants will be asked to reduce overall salt intake and to use LSSS on every occasion where regular salt would normally be used, including as cooking salt.
- Conditions
- Hypertension
- Being tested
- Low-sodium salt substitute
- Keywords
- Hypertension, Low sodium salt substitute, Cardiovascular disease, RASi
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-sodium salt substituteDietary supplement
The low sodium salt substitute contains 25% potassium chloride (KCl range; 20%-35%)
| Study group | Role | What they receive |
|---|---|---|
| Low sodium salt substitute (LSSS) | Experimental | Participants are asked to reduce overall salt intake and to use LSSS on every occasion where regular salt would normally be used, including as cooking salt Receives: Dietary Supplement: Low-sodium salt substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident hyperkalemia (K ≥5.5 mmol/L)
Measured: 4 and 8 weeks
Proportion of the correction of hypokalemia (from K <3.5 mmol/L to 3.5-5.0 mmol/L)
Measured: 4 and 8 weeks
Secondary outcomes (3)
Change in serum potassium levels
Measured: 4 and 8 weeks
Change in systolic and diastolic blood pressure (mmHg)
Measured: 4 and 8 weeks
Number of Participants Adherent to LSSS use
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start8 Aug 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post study
- Masking
- None (open label)
- Enrolment
- 607 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Foundation of Bangladesh, Vital Strategies
- Responsible party
- Sponsor
- Investigators
- Junichi Ishigami, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460882
- Sponsor's protocol ID
- IRB00520279
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional review board restrictions and participant privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Low Sodium Salt Substitute Use on Serum Potassium Levels Among Patients With Hypertension
- ClinicalTrials.gov ID
- NCT07460882
- Acronym / sponsor ID
- IRB00520279
- Conditions
- Hypertension
- Keywords
- Hypertension, Low sodium salt substitute, Cardiovascular disease, RASi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 607 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart Foundation of Bangladesh, Vital Strategies
- Study start
- 8 Aug 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
The goal of this pre-post study is to assess the risk of hyperkalemia in adults with hypertension on medication in Bangladesh. The main questions it aims to answer are:
Is the risk of hyperkalemia after the initiation of Low Sodium Salt Substitute (LSSS) in people on antihypertensive medication (especially RASi) large enough to be concerned about its broad use in this population?
Does initiation of LSSS correct hypokalemia in people on antihypertensive medication (especially RASi) with low serum potassium levels?
Participants will be asked to reduce overall salt intake and to use LSSS on every occasion where regular salt would normally be used, including as cooking salt.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post study
| Arm | Type | Receives |
|---|---|---|
| Low sodium salt substitute (LSSS) | Experimental | Dietary Supplement: Low-sodium salt substituteParticipants are asked to reduce overall salt intake and to use LSSS on every occasion where regular salt would normally be used, including as cooking salt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥18 years with clinically diagnosed hypertension treated with medication [on a stable dose at least for 2 months]
- Have a phone for contact
Key exclusion criteria (5 listed)
- Those with baseline K ≥5.0 or K <3.0 mmol/L
- Advanced kidney disease (eGFR <45 ml/min/1.73m2).
- Those on potassium sparing diuretics (e.g., spironolactone)
- Other medical conditions determined by physicians (e.g., heart failure treated with medication; life expectancy less than 12 months)
- Dine out for dinner more than 3 times a week
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 |
|---|---|---|
| Low-sodium salt substituteThe low sodium salt substitute contains 25% potassium chloride (KCl range; 20%-35%) | Dietary supplement | Low sodium salt substitute (LSSS) |
Primary outcome
Incident hyperkalemia (K ≥5.5 mmol/L)
Time frame: 4 and 8 weeks
Proportion of the correction of hypokalemia (from K <3.5 mmol/L to 3.5-5.0 mmol/L)
Time frame: 4 and 8 weeks
3 secondary outcomes
Change in serum potassium levels
Time frame: 4 and 8 weeks
Change in systolic and diastolic blood pressure (mmHg)
Time frame: 4 and 8 weeks
Number of Participants Adherent to LSSS use
Time frame: 4 and 8 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 21 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional review board restrictions and participant privacy considerations.
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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.
Sohel Reza Choudhury, MD, PhD contact
Junichi Ishigami, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-sodium salt substitute in people with Hypertension, run by Johns Hopkins University at 1 site in Bangladesh.
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 2 inclusion and 5 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 21 Aug 2026. 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 Bangladesh. 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.
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 Junichi Ishigami, MD, PhD (14432877262, jishiga1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident hyperkalemia (K ≥5.5 mmol/L) (time frame: 4 and 8 weeks). The study lists 2 primary outcomes in all. 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 21 Aug 2026.