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

University of Calgary

Status: Enrolling

Conditions: Hormone Therapy

Treatments: Drug: Iohexol; Drug: Captopril Tablets

Study type: Observational

Funder types: Other

Identifiers

NCT05442463

REB19-0460

Details and patient eligibility

About

1. 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.
2. 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.

Full description

Participants are screened for eligibility.

Study involves a 4.5 hour morning in the lab:

1. Participants come fasting
2. IV infusion and blood draws
3. Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Cisgender and transgender women

Description:

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.

Treatment:

Drug: Captopril Tablets

Drug: Iohexol

Cisgender and transgender men

Description:

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.

Treatment:

Drug: Captopril Tablets

Drug: Iohexol