Effect of Azilsartan on Aldosterone in Postmenopausal Females

Effect of Azilsartan on Aldosterone in Postmenopausal Females

The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females.

The study is a randomized, placebo-controlled trial of post-menopausal females with stage 1 hypertension. The goal is to randomize 40 post-menopausal females with stage 1 hypertension and assess whether azilsartan reduces urinary aldosterone levels. We will compare subjects having azilsartan medoximil (treatment group) with placebo group. Additionally, a small sub-study comparing pre-menopausal and post-menopausal female aldosterone levels was performed as well as the presence of aldosterone production in fat cell cultures of a subset of 3 patients in the randomized trial.

Inclusion Criteria:

• Female
• Ages 45-70
• Post-menopause: have not had a menstrual period for one year or more
• Diagnosed with Stage 1 hypertension
• Body Mass Index (BMI) greater than or equal to 28

Exclusion Criteria:

• Male
• Diagnosed with Stage 2 hypertension
• Stage 1 hypertension requiring more than one agent
• Pregnancy or attempting pregnancy
• Use of oral contraceptive pills
• Use of hormone replacement therapy
• Use of steroids
• Stage 3 or greater kidney disease
• Diabetes mellitus
• untreated hypothyroidism or hyperthyroidism
• primary hyperaldosteronism
• Cushing's disease
• obstructive sleep apnea
• chronic illness, e.g. chronic liver disease
• NYHA class III or greater heart failure
• moderate to severe lung disease