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."
Eligibility
Sex
FEMALE
Min age
45 Years
Max age
75 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
MACCE — 10 years defined as death, cardiovascular death, myocardial infarction, stroke, Transient Ischemic Attack, revascularization
Trial sites (2)
Facility
City
Region
Status
Clinic for Cardiology, Angiology and Intensive Care at Charité Mitte Berlin
Berlin
Germany
University Hospital Duesseldorf
Düsseldorf
Germany
More Heinrich-Heine University, Duesseldorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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