Estrogen Diastolic Heart Failure
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Menopause
In brief
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).
Key facts
- Study ID
- NCT02693002
- Run by
- Gretchen Wells
- People needed
- 4
- Starts
- 2016-02-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2018-08-08
Who can join
Age: 45 and older, up to 55. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Kentucky — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.