The ECLA/PHRI Intervention in the Community Trial

EPIC is a cluster-randomized, double-blind trial to evaluate the effect of two potassium-enriched salt substitute preparations (one available in the Argentine market and one derived from it), compared to regular salt on systolic blood pressure in subjects ≥ 18 and ≤ 90 years old from Rosario department households in Santa Fe Province, Argentina.

Inclusion Criteria:Subjects ≥ 18 and ≤ 90 years old will be included, with no specific clinical conditions from households that meets the following criteria:The household must be composed of at least 2 individualsAt least 1 of the individuals included must be over 40 years of ageThe household must be located in Rosario department, Santa Fe province, ArgentinaExclusion Criteria:Households will be excluded if a any household member has a at least one of the following contraindication to the salt substitute used in the trial:use of a potassium-sparing diureticuse of a potassium supplementknown history of hyperkalemiause of salt reduced in sodium and enriched in potassium by medical indicationdo not consume any type of salt for medical indicationknown primary or secondary hyperaldosteronismknown severe kidney disease (routine biochemical measurement of kidney function will not be performed in household members not included in the study).Pregnancy or lactationEvidence of hyperkalemia and/or a creatinine clearance (calculated through the CKD-EPI formula <30 ml/min/1.73m2) in baseline blood laboratory. For those participants who consent to be tested, blood sample will be used. For those participant who has a laboratory test performed with those biomarkers in the past 6 months those results will be consideredHouseholds in which any of the study participants consume more than 50% of their meals prepared outside their home will also be excluded.