Estrogen Diastolic Heart Failure
Status: | Terminated |
---|---|
Conditions: | Cardiology, Women's Studies |
Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
Healthy: | No |
Age Range: | 45 - 55 |
Updated: | 8/10/2018 |
Start Date: | February 2016 |
End Date: | November 2016 |
Heart Failure Prevention for Women: Preservation of Cardiac Function in the Peri-Menopausal Woman Through Hormone Therapy
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).
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).
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.
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.
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
We found this trial at
1
site
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
Click here to add this to my saved trials