Conditions: Menopause
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: yes

Brief summary:
Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12 weeks to determine if markers of systolic and diastolic function change by echocardiography as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).

Detailed description:
This preliminary, feasibility study will randomize 28 peri-menopausal women to either hormone replacement therapy or placebo for 12 weeks. Prior to randomization, each participant will undergo echocardiography, measurements of activity using the Duke Activity Status Index, measurements of quality of life and laboratory data, including b-type natriuretic peptide (BNP) measurements. Following the intervention for 12 weeks, these measurements will all be repeated.

Arms:
arm 1: Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks arm 2: Inert ingredients by mouth oral daily for 12 weeks

Interventions: intervention 1: Estradiol/Norethindrone acetate intervention 2: Placebo
Intervention descriptions: intervention 1: Estradiol/Norethindrone acetate 1mg/0.5 mg intervention 2: inactive ingredient

Protocol document: