Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05442463

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location status: Recruiting

Location contact

Darlene Y Sola, BScN

CONTACT

[email protected]

4036149431

Sandra Dumanski, MD

SUB_INVESTIGATOR

Sofia Ahmed, MD

PRINCIPAL_INVESTIGATOR

Victoria Riehl-Tonn, BN

CONTACT

[email protected]

4036149431

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Captopril Tablets

Drug

Captorpril challenge to each participant

Other names: Capoten

Iohexol

Drug

Iohexol infusion to evaluate measured GFR

Other names: Omnipaque

Primary outcomes

  1. First association in transgender women and cis women

    Time frame: 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.

  2. Second association in transgender men and cis men

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Darlene Y Sola, BScN

CONTACT

[email protected]

4032107434

Victoria Riehl-Tonn, BN

CONTACT

[email protected]

4032109434

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Hormone Therapy and Angiotensin-Dependent Arterial and Renal

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2022
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.