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

Hormone Therapy and Angiotensin-Dependent Arterial and Renal

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.

Study Overview

• Status: Recruiting
• Conditions: Hormone Therapy
• Intervention / Treatment: Drug: Captopril Tablets; Drug: Iohexol

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Darlene Y Sola, BScN; Phone Number: 4032107434; Email: dsola@ucalgary.ca
• Study Contact Backup: Name: Victoria Riehl-Tonn, BN; Phone Number: 4032109434; Email: victoria.riehltonn@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Recruiting
      • University of Calgary
      • Contact: Darlene Y Sola, BScN; Phone Number: 4036149431; Email: dsola@ucalgary.ca
      • Contact: Victoria Riehl-Tonn, BN; Phone Number: 4036149431; Email: victoria.riehltonn@ucalgary.ca
      • Principal Investigator: Sofia Ahmed, MD
      • Sub-Investigator: Sandra Dumanski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy adult ages 18 - 90 years cisgender (gender identity that aligns with sex at birth) and transgender (gender identity that does not align with sex at birth) adult women and men who are on oral, non-oral or no hormone therapy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cisgender and transgender women; 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; Captorpril challenge to each participant; Other Names: Capoten; Drug: Iohexol; Iohexol infusion to evaluate measured GFR; Other Names: Omnipaque
Cisgender and transgender men; 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; Captorpril challenge to each participant; Other Names: Capoten; Drug: Iohexol; Iohexol infusion to evaluate measured GFR; Other Names: Omnipaque

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Dr. Sandra Dumanski
• Investigators: Principal Investigator: Sofia Ahmed, MD, Alberta Health Services

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: hormone replacement therapy; HRT; post menopausal hormone replacement therapy; transgender men; transgender women; nonbinary; cis gender; post menopause
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Antihypertensive Agents; Angiotensin-Converting Enzyme Inhibitors; Captopril
• Other Study ID Numbers: REB19-0460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No