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RecruitingNCT07460882Updated Aug 21, 2026

The Impact of Low Sodium Salt Substitute Use on Serum Potassium Levels Among Patients With Hypertension

An interventional study of Low-sodium salt substitute in Hypertension, sponsored by Johns Hopkins University. Recruiting at 1 site in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
607
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypertension

Keywords

  • Hypertension
  • Low sodium salt substitute
  • Cardiovascular disease
  • RASi
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 607 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults ≥18 years with clinically diagnosed hypertension treated with medication [on a stable dose at least for 2 months]
  • Have a phone for contact

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
607 participants (estimated)

Study arms

  • Experimental
    Low sodium salt substitute (LSSS)

    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

    Dietary Supplement: Low-sodium salt substitute

Interventions

  • Dietary supplementLow-sodium salt substitute

    The low sodium salt substitute contains 25% potassium chloride (KCl range; 20%-35%)

06

What researchers measure

Primary outcomes

  1. Incident hyperkalemia (K ≥5.5 mmol/L)

    Time frame: 4 and 8 weeks

  2. 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

Secondary outcomes

  1. Change in serum potassium levels

    Time frame: 4 and 8 weeks

  2. Change in systolic and diastolic blood pressure (mmHg)

    Time frame: 4 and 8 weeks

  3. Number of Participants Adherent to LSSS use

    Time frame: 4 and 8 weeks

07

Study locations

1 of 1 sites recruiting
  • The National Heart Foundation of Bangladesh
    Dhaka, Bangladesh
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to institutional review board restrictions and participant privacy considerations.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07460882
Lead sponsor
Johns Hopkins University
Collaborators
National Heart Foundation of Bangladesh, Vital Strategies
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Aug 8, 2026
Primary completion
Mar 31, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

Junichi Ishigami, MD, PhD
Contact
jishiga1@jhu.edu
14432877262
Sohel Reza Choudhury, MD, PhD
Contact
Junichi Ishigami, MD, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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