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ClinicalTrials.gov ID

NCT07394049

Lead Sponsor

Heinrich-Heine University, DuesseldorfOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

3,408Estimated

Last Update Posted

Jul 31, 2026Actual

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Mar 2041Estimated

Completion Date

Mar 2041Estimated

Official Title

Cardiovascular Assesment Under Current Hormone Replacement Therapy in Menopause (CATCH-Menopause)

Brief Summary

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

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.

• Hormone Replacement Therapy
• Cardiovascular Diseases
• Hormone Replacement Therapy, Post-Menopausal
• Menopause

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

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

Observational Model

Case-Control

Time Perspective

Prospective

Lead Sponsor

Heinrich-Heine University, DuesseldorfOTHER

ctu@med.uni-duesseldorf.de+492118118567