The ECLA/PHRI Intervention in the Community Trial

Launched by ESTUDIOS CLÍNICOS LATINO AMÉRICA · Nov 25, 2022

Keywords

ClinConnect Summary

The ECLA/PHRI Intervention in the Community Trial is studying how two different potassium-enriched salt substitutes affect blood pressure in people with hypertension. This trial is taking place in Rosario, Argentina, and is looking for participants aged between 18 and 90 years. To be eligible, you need to live in a household with at least two people, and at least one of those individuals must be over 40 years old. However, some people will not be able to join if they have certain health conditions, such as severe kidney disease or if they are pregnant or breastfeeding.

If you decide to participate, you will be part of a study to see if using these salt substitutes can help lower blood pressure compared to regular salt. The trial is currently recruiting participants, so if you or someone you know fits the eligibility criteria and is interested, it could be a chance to contribute to important research on hypertension. Remember, you’ll need to be living in the Rosario department and meet the household requirements to qualify.

Gender

ALL

Eligibility criteria

• 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 individuals
• • At least 1 of the individuals included must be over 40 years of age
• • The household must be located in Rosario department, Santa Fe province, Argentina
• Exclusion 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 diuretic
• • use of a potassium supplement
• • known history of hyperkalemia
• • use of salt reduced in sodium and enriched in potassium by medical indication
• • do not consume any type of salt for medical indication
• • known primary or secondary hyperaldosteronism
• • known severe kidney disease (routine biochemical measurement of kidney function will not be performed in household members not included in the study).
• • Pregnancy or lactation
• • Evidence 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 considered
• • Households in which any of the study participants consume more than 50% of their meals prepared outside their home will also be excluded.

Trial Officials