Heart Failure Prevention for Women: Preservation of Cardiac Function in the Peri-Menopausal Woman Through Hormone Therapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Diastolic Function Assessed by Echocardiography
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Hormone replacement therapy
Estradiol/norethindrone acetate 1mg/0.5 mg by mouth oral daily for 12 weeks
干预措施: Estradiol/Norethindrone acetate (Drug)
Placebo
Inert ingredients by mouth oral daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Diastolic Function Assessed by Echocardiography
时间窗: Baseline and 12 weeks
Change in diastolic function as assessed by echocardiography from baseline to 12 weeks
次要结局
- Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS)(Baseline and 12 weeks)
- B-type Natriuretic Peptide (BNP) Levels(Baseline and 12 weeks)
- Activity Level Assessed by Duke Activity Status Index (DASI)(Baseline and 12 weeks)
研究者
Gretchen Wells
Professor
University of Kentucky