Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age45+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

The goal of this clinical trial is to learn whether it is feasible to conduct a larger study comparing transdermal menopausal hormone therapy (MHT) versus no hormone therapy in menopausal women with vasomotor symptoms (hot flashes and night sweats) and at least one cardiovascular risk factor. The main questions it aims to answer are:

* What proportion of eligible women agree to be randomly assigned to either receive MHT or not? * How many participants complete the 12-month follow-up, including repeat heart imaging? * Does transdermal MHT affect early changes in heart muscle tissue as measured by cardiac MRI?

Researchers will compare immediate initiation of transdermal estradiol (a skin gel or patch) to a no-hormone therapy strategy to see if MHT influences early cardiovascular and brain-vascular changes over 12 months.

Participants will:

* Be randomly assigned to start transdermal MHT within 2 weeks, or to use no hormone therapy for at least the first 3 months * Undergo a cardiac MRI and retinal eye imaging at the start of the study and again at 12 months * Complete cognitive testing and questionnaires about symptoms, sleep, and stress at both visits * Provide a blood sample for storage and future analysis of heart and brain health markers * Receive follow-up phone calls at 3, 6, and 9 months to review symptoms, medications, and any health changes

Eligibility criteria

Qualifiers

Women aged ≥ 45 years.

Perimenopause, defined as menstrual cycle irregularity (changes in cycle length, skipped cycles, or amenorrhea ≥ 60 days) accompanied by vasomotor symptoms consistent with the menopausal transition.

≥ 12 months of spontaneous amenorrhea, or

bilateral oophorectomy, or

Disqualifiers

Prior cardiovascular event or established cardiovascular disease, including myocardial infarction, stroke or TIA, coronary artery disease, heart failure, cardiomyopathy, or clinically significant valvular heart disease.

Uncontrolled hypertension or other unstable cardiovascular condition (e.g., unstable angina, decompensated heart failure, uncontrolled arrhythmia).

Formal contraindication to systemic menopausal hormone therapy, including estrogen-dependent cancer, unexplained vaginal bleeding, active severe liver disease, severe thrombophilia, antiphospholipid syndrome, prior or active VTE.

Standard contraindications to MRI (e.g., MRI-incompatible pacemakers or intracardiac devices, certain metallic implants, metallic foreign bodies in the eye, or severe claustrophobia not manageable).

Trial design

Treatments tested in this trial

  • Transdermal estradiol
  • Standard of care - non hormonal

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations