Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Gender Dysphoria trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorMedical University of Vienna
Academic / other
Locations1 site (Vienna, State of Vienna)
StatusRecruiting
StartedMarch 3, 2023
Main results expectedMarch 3, 2027
Study endsMarch 3, 2033
Registry record updatedSeptember 26, 2025
Trial IDNCT06291675 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.