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Tissue Sodium in Pre-hypertensive Patients

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Spironolactone (Drug); Chlorthalidone (Drug); Diet (Dietary Supplement); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Alp Ikizler, MD, Principal Investigator, Affiliation: Vanderbilt University
Jens Titze, MD, Principal Investigator, Affiliation: Vanderbilt University

Overall contact:
Alp Ikizler, MD, Phone: 615-343-6104


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


- 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

Clinical Details

Official title: Tissue Sodium in Pre-hypertensive Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: change in Na+ tissue stores by study arm


Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria:

- Age 30 to 80 years old;

- Systolic blood pressures between 120 to 139 mmHg and/or diastolic blood pressure

between 80-89 mmHg;

- Ability to give informed consent.

Exclusion Criteria:

- Pregnancy;

- Intolerance to study protocols;

- Acute cardiovascular events within the previous 6 months;

- Impaired renal function (estimated GFR < 45 ml/min/1. 73m2);

- Current or recent treatment with systemic glucocorticoid therapy (within 1 month of


- Current use of anti-hypertensive medication;

- Diabetes mellitus requiring medical therapy;

- Morbid obesity (BMI > 45);

- Prior adverse reaction to a thiazide or spironolactone;

- Claustrophobia preventing the patient from having an MRI or other contraindications

to MRI;

- Impaired hepatic function (aspartate amino transaminase and/or alanine amino

transaminase > 1. 5x upper limit of normal range);

- Current illicit drug use;

- Sexually active women of childbearing potential** who are unwilling to practice

adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

- Postmenopausal women must be amenorrheic for at least 12 months in order not to

be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Locations and Contacts

Alp Ikizler, MD, Phone: 615-343-6104

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Muge Deger, MD, Phone: 615-343-6225, Email: serpil.deger@vanderbilt.edu
Alp Ikizler, MD, Principal Investigator
Additional Information

Starting date: September 2014
Last updated: July 16, 2015

Page last updated: August 23, 2015

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