Impact of New Hormone Replacement Therapy After Menopause on Heart Health in Women

NCT07394049 | Not Yet Recruiting

• 1 other identifier: Catch-menopause
• Study Type: observational
• Target: 2,725
• Locations: 1 country
• Sites: 2

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."

Conditions

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

Keywords

hormone replacement therapy; cardiovascular disease; menopause

Outcome Measures

Primary Outcomes (1)

• MACCE

  defined as death, cardiovascular death, myocardial infarction, stroke, Transient Ischemic Attack, revascularization

  10 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Study Population: Peri and postmenopausal women with cardiovascular disease or high risk for CVD with and without hormon replacement therapy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (2)

Clinic for Cardiology, Angiology and Intensive Care at Charité Mitte Berlin

Berlin, Germany

Location

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

prospectively defined blood sampling protocol

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Malte Kelm, MD

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

  STUDY DIRECTOR

• Lisa Dannenberg, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Dannenberg, MD

CONTACT

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

Saskia Pietrucha, M.Sc.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2035
• Study Completion (Estimated): March 1, 2035
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)