Effects of gender-affirming hormone therapy on heart and metabolic health
Official title: Long-term Observational Study to Investigate the Effect of Gender-affirming Hormone Therapy (GAHT) on Heart Function Parameters, Heart, Liver and Pancreatic Fat Content as Well as the Insulin System and the Psychological Impact of GAHT
Run by Medical University of Vienna · NCT06291675 · Data updated 2026-11-12
This study is trying to see how gender-affirming hormone therapy affects heart health, metabolism, and mental well-being in transgender people over several years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Status | Recruiting |
| Started | March 3, 2023 |
| Main results expected | March 3, 2027 |
| Study ends | March 3, 2033 |
| Registry record updated | September 26, 2025 |
| Trial ID | NCT06291675 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are transgender men and women who have been undergoing gender-affirming hormone therapy for at least two years.
✕Probably not a fit
Patients under 18 years of age or those with non-MRI conditional implants, tattoos, or current substance abuse issues 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 investigates the long-term effects of gender-affirming hormone therapy (GAHT) on cardiovascular health, insulin sensitivity, body composition, and psychological well-being in transgender individuals. Participants will be monitored over a period of 2, 5, and 10 years to assess changes in myocardial mass, cardiac function, and fat content in the heart, liver, and pancreas. The study aims to fill the gap in existing research regarding the mid- to long-term impacts of GAHT, which has been largely overlooked in previous studies.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term health implications of gender-affirming hormone therapy, potentially leading to improved care strategies for transgender individuals.
How similar studies have gone: While there is some existing research on the short-term effects of GAHT, this study's focus on long-term outcomes is relatively novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * participation in our pilot study * ongoing gender affirming hormone therapy during the last 2 years * willingness and competence to sign the informed consent form. Exclusion Criteria: * age \< 18 years * non-MRI conditional implants, grafts, and/or devices * non-MRI conditional tattoos * claustrophobia * current substance abuse * pregnancy * failure to comply with the study protocol and/or not following the instructions of the study team.
Where it's running
-
Chiari Stoffwechselambulanz, Medical University of Vienna
Vienna, State of Vienna, Austria Recruiting
Study contacts
- Principal investigator: Alexandra Kautzky-Willer, Prof, MD — Medical University of Vienna
- Study coordinator: Carola Deischinger, MD PHD
- Email: carola.deischinger@meduniwien.ac.at
- Phone: +43140400
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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.