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

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

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."

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Menopause; Hormone Replacement Therapy; Hormone Replacement Therapy, Post-Menopausal

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.

• Study Type: Observational
• Enrollment (Estimated): 2725

Contacts and Locations

• Study Contact: Name: Lisa Dannenberg, MD; Phone Number: +49 2118105187; Email: LisaKristina.Dannenberg@med.uni-duesseldorf.de
• Study Contact Backup: Name: Saskia Pietrucha, M.Sc.; Phone Number: +49 2118105187; Email: saskia.pietrucha@med.uni-duesseldorf.de

Study Locations

• Germany
  • Berlin, Germany
    • Clinic for Cardiology, Angiology and Intensive Care at Charité Mitte Berlin
    • Contact: Julia Lueg, MD; Phone Number: +49 30 450 613 174; Email: ulia.lueg@dhzc-charite.de
    • Principal Investigator: Julia Lueg, MD
  • Düsseldorf, Germany, 40225
    • University Hospital Duesseldorf
    • Principal Investigator: Lisa Dannenberg, MD
    • Contact: Lisa Dannenberg, MD; Phone Number: +492118118567; Email: ctu@med.uni-duesseldorf.de
    • Contact: Saskia Pietrucha, M.Sc.; Phone Number: + 49211 81 05187; Email: ctu@med.uni-duesseldorf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study Population: Peri and postmenopausal women with cardiovascular disease or high risk for CVD with and without hormon replacement therapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Post menopausal women with hormone replacement therapy; Postmenopausal women who have been in menopause and have taken any hormone replacement therapy (HRT).
Post menopausal women without hormone replacement therapy (Control); 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Director: Malte Kelm, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf; Principal Investigator: Lisa Dannenberg, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2035
• Study Completion (Estimated): March 1, 2035

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: menopause; cardiovascular disease; hormone replacement therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: Catch-menopause

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not necessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No