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

NCT07460882 | Not Yet Recruiting DMC

• 1 other identifier: IRB00520279
• Study Type: interventional
• Target: 607
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; Low sodium salt substitute; Cardiovascular disease; RASi

Outcome Measures

Primary Outcomes (2)

• Incident hyperkalemia (K ≥5.5 mmol/L)

  4 and 8 weeks

• Proportion of the correction of hypokalemia (from K <3.5 mmol/L to 3.5-5.0 mmol/L)

  4 and 8 weeks

Secondary Outcomes (3)

• Change in serum potassium levels

  4 and 8 weeks

• Change in systolic and diastolic blood pressure (mmHg)

  4 and 8 weeks

• Number of Participants Adherent to LSSS use

  4 and 8 weeks

Study Arms (1)

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

Dietary Supplement: Low-sodium salt substitute

Interventions

Low-sodium salt substitute DIETARY_SUPPLEMENT

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

Low sodium salt substitute (LSSS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Vital Strategies: collaborator
• National Heart Foundation of Bangladesh: collaborator

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Junichi Ishigami, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junichi Ishigami, MD, PhD

CONTACT

14432877262; jishiga1@jhu.edu

Sohel Reza Choudhury, MD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post study

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share