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

Not Yet RecruitingN/A

Sponsor: Heinrich-Heine University, Duesseldorf

Conditions: Hormone Replacement Therapy, Cardiovascular Diseases, Hormone Replacement Therapy, Post-Menopausal, Menopause

Countries: Germany

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 overview

Sex: FEMALE

Age: 45 Years to 75 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (2)

Berlin, Germany
Düsseldorf, Germany