An observational study in Hormone Replacement Therapy, Cardiovascular Diseases and Hormone Replacement Therapy, Post-Menopausal, sponsored by Heinrich-Heine University, Duesseldorf. Not yet recruiting at 2 sites in Germany. Open to female participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Heinrich-Heine University, Duesseldorf · Observational
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 3,408 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study Population: Peri and postmenopausal women with cardiovascular disease or high risk for CVD with and without hormon replacement therapy
Exclusion Criteria:
Postmenopausal women who have been in menopause and have taken any hormone replacement therapy (HRT).
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.
MACCE
defined as death, cardiovascular death, myocardial infarction, stroke, Transient Ischemic Attack, revascularization
Time frame: 10 years
Plan to share: No — not necessary
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Heinrich-Heine University, Duesseldorf