Investigating hormone therapy effects on heart and kidney health
Official title: Hormone Therapy and Angiotensin-Dependent Arterial and Renal
Run by University of Calgary · NCT05442463 · Data updated 2026-11-12
This study is trying to see how different ways of taking estrogen and testosterone affect heart and kidney health in both cisgender and transgender people.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Status | Recruiting |
| Started | November 30, 2020 |
| Main results expected | November 30, 2025 |
| Study ends | November 30, 2025 |
| Registry record updated | March 27, 2025 |
| Trial ID | NCT05442463 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 18 to 90 who are currently taking hormones, either estrogen, progesterone, or testosterone.
✕Probably not a fit
Patients with cardiovascular or cerebrovascular diseases, significant hypertension, diabetes, or those who are current smokers may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between the method of estrogen administration (transdermal vs. oral) and the associated cardiorenal risks in both cisgender and transgender women. Additionally, it will assess the impact of exogenous testosterone on cardiorenal risks in cisgender and transgender men. Participants will undergo a series of tests, including blood draws and non-invasive monitoring, during a 4.5-hour lab session while fasting. The study seeks to provide insights into how hormone therapy affects cardiovascular and renal health across different gender identities.
Why it matters
Potential benefit: If successful, this study could enhance understanding of hormone therapy's safety and risks, leading to better management strategies for patients undergoing such treatments.
How similar studies have gone: While there have been studies on hormone therapy, this specific investigation into the cardiorenal risks associated with different hormone administration routes is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University of Calgary
Calgary, Alberta, Canada Recruiting
Study contacts
- Principal investigator: Sofia Ahmed, MD — Alberta Health services
- Study coordinator: Darlene Y Sola, BScN
- Email: dsola@ucalgary.ca
- Phone: 4032107434
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.