Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans

Study Overview
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Brief Summary
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to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women. to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.

Detailed Description
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Participants are screened for eligibility. Study involves a 4.5 hour morning in the lab: Participants come fasting IV infusion and blood draws Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks

Official Title
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Hormone Therapy and Angiotensin-Dependent Arterial and Renal

Conditions
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Hormone Therapy

Intervention / Treatment
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* Drug: Captopril Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 90 years Taking hormones orally or non-orally (either estrogen, progesterone or testosterone) Exclusion Criteria: Cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening) Cerebrovascular disease (transient ischemic attacks or stroke) History of hypertension (BP>140/90 or use of antihypertensive medications) Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2 Diabetes mellitus (defined by history, use of hypoglycaemic agents or a fasting glucose >7mmol/L) Current smoker Previous history of preeclampsia Anabolic steroids, cortical steroids, or non-steroidal anti-inflammatory medications, or at the discretion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women<br>Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally. Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing. | Drug: Captopril Tablets<br>* Captorpril challenge to each participant<br>|
| men<br>Iohexol 5 ml IV push followed 10 ml IV flush of normal saline is administered to establish baseline GFR (glomerular filtration rate). FF (filtration fraction) is calculated as follows: GFR/RPF=FF. Captopril 25 mg is given orally. Blood will be collected at specific time points, pulse wave velocity testing 3 times throughout morning, Holter monitor and bioelectrical impedance testing. | Drug: Captopril Tablets<br>* Captorpril challenge to each participant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First association in transgender women and cis women | to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women. | 2025 | 
| Second association in transgender men and cis men | to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men. | 2025 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRT, post menopausal hormone replacement therapy, transgender men, transgender women, nonbinary, cis gender, post menopause, hormone replacement therapy