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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."
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| MACCE | defined as death, cardiovascular death, myocardial infarction, stroke, Transient Ischemic Attack, revascularization | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
Study Population: Peri and postmenopausal women with cardiovascular disease or high risk for CVD with and without hormon replacement therapy
Study Population: Peri and postmenopausal women with cardiovascular disease or high risk for CVD with and without hormon replacement therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Dannenberg, MD | Contact | +49 2118105187 | lisaKristina.Dannenberg@med.uni-duesseldorf.de | |
| Saskia Pietrucha, M.Sc. | Contact | +49 2118105187 | saskia.pietrucha@med.uni-duesseldorf.de |
| Name | Affiliation | Role |
|---|---|---|
| Malte Kelm, MD | Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf | Study Director |
| Lisa Dannenberg, MD | Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Cardiology, Angiology and Intensive Care at Charité Mitte Berlin | Berlin | Germany |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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prospectively defined blood sampling protocol
| University Hospital Duesseldorf | Düsseldorf | 40225 | Germany |
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