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

Recruiting

• Conditions: Hormone Therapy
• Interventions: Drug: Captopril Tablets; Drug: Iohexol

• Registration Number: NCT05442463
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2020-11-30
• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-07-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cisgender and transgender women	Captopril Tablets	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.
Cisgender and transgender women	Iohexol	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.
Cisgender and transgender men	Captopril Tablets	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.
Cisgender and transgender men	Iohexol	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.

Primary Outcome Measures

Name	Time	Method
First association in transgender women and cis women	2025	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.
Second association in transgender men and cis men	2025	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.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada