Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT02236520
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT02236520
Study Brief:
Protocol Section:
NCT02236520