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

NCT05442463 | Recruiting

• 1 other identifier: REB19-0460
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Hormone Therapy

Keywords

post menopausal hormone replacement therapy; transgender men; transgender women; nonbinary; cis gender; post menopause; HRT; hormone replacement therapy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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; Drug: Iohexol

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; Drug: Iohexol

Interventions

Captopril Tablets DRUG

Captorpril challenge to each participant

Also known as: Capoten

Cisgender and transgender men; Cisgender and transgender women

Iohexol DRUG

Iohexol infusion to evaluate measured GFR

Also known as: Omnipaque

Cisgender and transgender men; Cisgender and transgender women

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: transgender women, transgender men, cisgender women, cisgender men on oral and non oral hormone therapy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 to 90 years
• Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine, blood samples

MeSH Terms

Interventions

Captopril; Iohexol

Intervention Hierarchy (Ancestors)

Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sofia Ahmed, MD

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darlene Y Sola, BScN

CONTACT

4032107434; dsola@ucalgary.ca

Victoria Riehl-Tonn, BN

CONTACT

4032109434; victoria.riehltonn@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 5, 2022
• Study Start: November 30, 2020
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)