Estrogen Diastolic Heart Failure

Gretchen Wells

Status and phase: Terminated; Phase 4

Conditions: Menopause

Treatments: Drug: Estradiol/Norethindrone acetate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02693002

15-0798-F6A

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 28 healthy recently postmenopausal women with last menstrual bleeding 12 months at study entry. Women with last menstrual bleeding within 12 months at study entry are those who are peri-menopausal and for whom the drug is FDA approved.

Exclusion criteria

• History of hysterectomy, oophorectomy or both
• History of heart disease including cardiac transplantation, heart failure, bypass surgery or percutaneous intervention, and valve disease defined as moderate or severe valve regurgitation or stenosis
• History of bone disease including non-traumatic vertebral fractures on radiography
• Uncontrolled chronic disease (including uncontrolled diabetes defined as a hemoglobin A1C >8, uncontrolled hypertension defined as a systolic blood pressure >160 mmHg, awaiting organ transplant)
• Previous or current cancer, excluding basal cell carcinoma
• Previous or current thromboembolic disease
• Previous intolerance of Hormone replacement therapy (HRT) or Oral contraception (OC)
• Current or previous use of HRT within the past 3 months
• Current or recent (<12 months) substance abuse, including tobacco use
• No drug interactions with HRT
• No racial or ethnic groups will be excluded

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 2 patient groups, including a placebo group

Hormone replacement therapy

Active Comparator group

Description:

Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks

Treatment:

Drug: Estradiol/Norethindrone acetate

Placebo

Placebo Comparator group

Description:

Inert ingredients by mouth oral daily for 12 weeks

Treatment:

Drug: Placebo