Hormone Replacement TherapyCATCH-MenopausNCT07394049
A Prospective Multicenter Cohort Study of Contemporary Menopausal Hormone Therapy and Cardiovascular Outcomes
An observational study of Hormone Replacement Therapy and Cardiovascular Diseases, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hormone Replacement Therapy, Cardiovascular Diseases, Hormone Replacement Therapy, Post-Menopausal
- How many people
- 3,408 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Aug 2026to Mar 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study Population: Peri and postmenopausal women with cardiovascular disease or high risk for CVD with and without hormon replacement therapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites
Clinic for Cardiology, Angiology and Intensive Care at Charité Mitte Berlin
Berlin
Julia Lueg, MD, +49 30 450 613 174, ulia.lueg@dhzc-charite.de
Julia Lueg, MD
University Hospital Duesseldorf
Düsseldorf, 40225
Lisa Dannenberg, MD, +492118118567, ctu@med.uni-duesseldorf.de
Saskia Pietrucha, M.Sc., + 49211 81 05187, ctu@med.uni-duesseldorf.de
About this study
Official title: 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."
Read the 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.
- Conditions
- Hormone Replacement Therapy, Cardiovascular Diseases, Hormone Replacement Therapy, Post-Menopausal, Menopause
- Keywords
- hormone replacement therapy, cardiovascular disease, menopause
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
MACCE
defined as death, cardiovascular death, myocardial infarction, stroke, Transient Ischemic Attack, revascularization
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Aug 2026 (estimated)
- Primary completionMar 2041 (estimated)
- Study completionMar 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Replacement TherapyStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, MD, Study director, Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital DuesseldorfLisa Dannenberg, MD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394049
- Sponsor's protocol ID
- Catch-menopause
- Acronym
- CATCH-Menopaus
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not necessary
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Assesment Under Current Hormone Replacement Therapy in Menopause (CATCH-Menopause)
- ClinicalTrials.gov ID
- NCT07394049
- Acronym / sponsor ID
- CATCH-Menopaus / Catch-menopause
- Conditions
- Hormone Replacement Therapy, Cardiovascular Diseases, Hormone Replacement Therapy, Post-Menopausal, Menopause
- Keywords
- hormone replacement therapy, cardiovascular disease, menopause
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,408 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Mar 2041 (estimated)
- Study completion
- Mar 2041 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population: Peri and postmenopausal women with cardiovascular disease or high risk for CVD with and without hormon replacement therapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACCE
Time frame: 10 years
defined as death, cardiovascular death, myocardial infarction, stroke, Transient Ischemic Attack, revascularization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No. not necessary
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malte Kelm, MD study director
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Lisa Dannenberg, MD principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormone Replacement Therapy and Cardiovascular Diseases, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Dannenberg, MD (+49 2118105187, lisaKristina.Dannenberg@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.