A Prospective Multicenter Cohort Study of Contemporary Menopausal Hormone Therapy and Cardiovascular Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hormone Replacement Therapy, Cardiovascular Diseases, Hormone Replacement Therapy, Post-Menopausal, Menopause. Basic parameters: 45 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cardiovascular Assesment Under Current Hormone Replacement Therapy in Menopause (CATCH-Menopause)
Overview
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.
Primary outcome measures
- MACCE [Time frame: 10 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Germany · 2 centers
- Clinic for Cardiology, Angiology and Intensive Care at Charité Mitte Berlin — Berlin
- University Hospital Duesseldorf — Düsseldorf
Identifiers
NCT: NCT07394049 · Catch-menopause