Status:
COMPLETED
Tissue Sodium in Pre-hypertensive Patients
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
American Heart Association
Conditions:
Hypertension
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Age 30 to 80 years old;
- Systolic blood pressures between 110 to 150 mmHg and/or diastolic blood pressure between 80-99 mmHg;
- Ability to give informed consent.
Exclusion
- Pregnancy;
- Intolerance to study protocols;
- Acute cardiovascular events within the previous 6 months;
- Impaired renal function \[estimated glomerular filtration rate (GFR) \< 45 ml/min/1.73m\^2\];
- Current or recent treatment with systemic glucocorticoid therapy (within 1 month of enrollment);
- Current use of anti-hypertensive medication (except calcium channel blockers and beta blockers);
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT02236520
Start Date
September 1 2014
End Date
May 1 2018
Last Update
May 22 2019
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232