A Prospective Multicenter Cohort Study of Contemporary Menopausal Hormone Therapy and Cardiovascular Outcomes

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.

Inclusion criteria

• 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

Exclusion criteria

• 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