CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 71 enrolled
Drug / intervention
Spironolactone +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02236520
NCT02236520Phase 2Completed

Tissue Sodium in Pre-hypertensive Patients

Vanderbilt University·interventional·Posted Sep 10, 2014·Updated May 22, 2019

In Brief

A Phase 2 clinical trial evaluating Spironolactone, Chlorthalidone, and 2 other interventions for Hypertension. Completed, enrolled 71 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 10, 2014
Enrollment StartSep 1, 2014
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.8 years ago

Interventions

Spironolactonedrug

Chlorthalidonedrug

Dietdietary

Placebodrug