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
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
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
Eligibility
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
enrollment);
- 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
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