Investigating hormone therapy effects on heart and kidney health
Hormone Therapy and Angiotensin-Dependent Arterial and Renal
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05442463 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 90 who are currently taking hormones, either estrogen, progesterone, or testosterone.
Not a fit: Patients with cardiovascular or cerebrovascular diseases, significant hypertension, diabetes, or those who are current smokers may not benefit from this study.
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 performed: While there have been studies on hormone therapy, this specific investigation into the cardiorenal risks associated with different hormone administration routes is relatively novel.
Eligibility criteria
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 this trial is running
Calgary, Alberta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.