Impact of New Hormone Replacement Therapy After Menopause on Heart Health in Women (CATCH-Menopaus)

Heinrich-Heine University, Duesseldorf

Status: Not yet enrolling

Conditions: Hormone Replacement Therapy; Menopause; Cardiovascular Diseases; Hormone Replacement Therapy, Post-Menopausal

Study type: Observational

Funder types: Other

Identifiers

NCT07394049

Catch-menopause

Details and patient eligibility

About

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."

Full 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.

Enrollment: 2,725 estimated patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 45-75 years
• Score 2 > 5%
• Or existing coronary heart disease
• Or cAVK
• Or PAD

Exclusion criteria

• Age <45 years / > 75 years
• Existing cancer
• Language barrier, inability to provide informed consent
• GFR <30 ml/min or dialysis
• Child C cirrhosis of the liver
• Known genetic cardiomyopathies

Trial design

2,725 participants in 2 patient groups

Post menopausal women with hormone replacement therapy

Description:

Postmenopausal women who have been in menopause and have taken any hormone replacement therapy (HRT).

Post menopausal women without hormone replacement therapy (Control)

Description:

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.