About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥18 years with clinically diagnosed hypertension treated with medication [on a stable dose at least for 2 months]
Have a phone for contact
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
Low-sodium salt substitute
Dietary supplementThe low sodium salt substitute contains 25% potassium chloride (KCl range; 20%-35%)
Treatment groups
Trial outcomes
Primary outcomes
Incident hyperkalemia (K ≥5.5 mmol/L)
Proportion of the correction of hypokalemia (from K <3.5 mmol/L to 3.5-5.0 mmol/L)
Secondary outcomes
Change in serum potassium levels
Change in systolic and diastolic blood pressure (mmHg)
Number of Participants Adherent to LSSS use
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Heart Foundation of Bangladesh
Collaborator
Vital Strategies
Collaborator