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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07394049

Acronym

CATCH-Menopaus

Enrollment

3408

Registered

2026-02-06

Start date

2026-08-01

Completion date

2041-03-01

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

hormone replacement therapy, cardiovascular disease, 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
MACCE	10 years	defined as death, cardiovascular death, myocardial infarction, stroke, Transient Ischemic Attack, revascularization

Countries

Germany

Contacts

CONTACTLisa Dannenberg, MD

lisaKristina.Dannenberg@med.uni-duesseldorf.de+49 2118105187

CONTACTSaskia Pietrucha, M.Sc.

saskia.pietrucha@med.uni-duesseldorf.de+49 2118105187

STUDY_DIRECTORMalte Kelm, MD

Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

PRINCIPAL_INVESTIGATORLisa Dannenberg, MD