Cardiovascular Assesment Under Current Hormone Replacement Therapy in Menopause (CATCH-Menopause)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,408
- 试验地点
- 2
- 主要终点
- MACCE
研究概览
简要总结
This prospective registry study investigates the impact of new hormone replacement therapy (HRT) delivery methods, such as creams, gels, and sprays, on cardiovascular risk in postmenopausal women. Menopause-related estrogen deficiency leads to metabolic and vascular changes that increase atherosclerosis and cardiovascular events. This study hypothesizes that new HRT forms may reduce cardiovascular risk in high-risk women."
详细描述
Detailed Description:
This prospective, longitudinal registry study will enroll peri- and postmenopausal women aged 45-75 years with cardiovascular disease, peripheral or cerebrovascular disease, a SCORE2 >5%, evidence of coronary artery disease progression, and who are receiving hormone replacement therapy (HRT). Age-matched postmenopausal women not receiving HRT will serve as controls.
Participants will be recruited from outpatient gynecology, cardiology and endocrinology clinics and followed for 10 years, with pseudonymized data collected on clinical events, cardiovascular and menopausal risk factors, lifestyle, lab values, and HRT details.
Blood samples will be collected during routine care with additional tubes for hormone and inflammatory marker analyses, and biobanking for up to 10 years. Follow-up visits will occur at 6 months and 1 year, with re-evaluation of clinical events, risk factors, menopausal symptoms, and HRT. Asymptomatic participants will not undergo additional testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female sex
- •Age 45-75 years at enrollment
- •Perimenopausal or postmenopausal status documented according to prespecified clinical criteria
- •Increased cardiovascular risk, defined as SCORE > 5 % (age 45-69 years) or SCORE2-OP > 5 % (age > 70 years), or established disease
- •Established cardiovascular disease includes coronary artery disease, cerebrovascular disease and/or peripheral artery disease, as specified in the approved protocol
- •Ability to understand the study procedures and provide written informed consent
排除标准
- •Age <45 years or > 75 years
- •Active malignancy at screening
- •Inability to provide written informed consent or to comply with study procedures
- •Severe renal impairment, defined as estimated glomerular filtrate rate <30 ml/min/1.73m2, or dialysis dependance
- •Advanced liver disease, defined as Child-Pugh class C
- •Known genetic cardiomyopathiy
研究组 & 干预措施
Post menopausal women with hormone replacement therapy
Postmenopausal women who have been in menopause and have taken any hormone replacement therapy (HRT).
Post menopausal women without hormone replacement therapy (Control)
Postmenopausal women who have been in menopause and have not taken any hormone replacement therapy (HRT) These participants serve as the control cohort to compare outcomes against those receiving HRT.
结局指标
主要结局
MACCE
时间窗: 10 years
defined as death, cardiovascular death, myocardial infarction, stroke, Transient Ischemic Attack, revascularization
次要结局
未报告次要终点