Hypertension
Conditions
Keywords
Hypertension, Low sodium salt substitute, Cardiovascular disease, RASi
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.
Interventions
DIETARY_SUPPLEMENTLow-sodium salt substitute
The low sodium salt substitute contains 25% potassium chloride (KCl range; 20%-35%)
Sponsors
Johns Hopkins University
National Heart Foundation of Bangladesh
Vital Strategies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pre-post study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Bangladesh
Contacts
CONTACTJunichi Ishigami, MD, PhD
CONTACTSohel Reza Choudhury, MD, PhD
PRINCIPAL_INVESTIGATORJunichi Ishigami, MD, PhD
Johns Hopkins University
Outcome results
None listed