drugset / Trial / NCT02236520

Tissue Sodium in Pre-hypertensive Patients

NCT02236520

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Cardiovascular disease is the first common cause of death worldwide. Hypertension is the number one driving risk factor. Hypertension has long been associated with dietary salt intake. We believe that the accumulation of salt in the interstitium and inside cells represents a neglected risk factor, which initiates a pro-inflammatory state, chronically increases blood pressure, and leads to systemic energy imbalance. We will explore the concept that Na+ storage in the skin and in muscle is associated with increased blood pressure, a pro-inflammatory state, and reduced insulin sensitivity. We will do so by addressing the following specific aims: * Specific Aim 1: To test the hypothesis that African Americans are characterized by increased tissue Na+ storage, which is paralleled by higher blood pressure, reduced forearm blood flow, and enhanced pulse wave velocity * Specific Aim 2: To test the hypothesis that treatment with spironolactone reduces tissue Na+ content * Specific Aim 3: To test the hypothesis that Na+ storage leads to immune cell activation * Specific Aim 4: To test the hypothesis that the accumulation of salt in skin and muscle is associated with decreased insulin sensitivity and propensity to diabetes mellitus

Timeline

Start
2014-09
Primary completion
2018-05-01
Completion
2018-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chlorthalidone Other / unclassified 25 mg Oral
Comparator Spironolactone Small molecule 50 mg Oral

Indications