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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age45-75
SponsorHeinrich-Heine University, Duesseldorf

About this trial

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."

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

3,408 Participants
are grouped into 2 trial groups
Group A: Post menopausal women with hormone replacement therapy
Group B: Post menopausal women without hormone replacement therapy (Control)

Trial outcomes

Primary outcomes

1

MACCE

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

Time frame
10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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