Cardiomodulatory Effects of Gender-Affirming Hormone Therapy

Gender-affirming hormone therapy is today a well-established treatment for individuals experiencing gender-incongruence. However, little is known about the long-term effects of gender-affirming hormone therapy on the cardiovascular system and it is unknown whether gender-affirming hormone therapy is associated with negative, neutral or perhaps positive effects on cardiovascular risk factors. The aim of the study The Cardiomodulatory Effects of Gender-Affirming Hormone Therapy (CARMEN) is therefore to contribute to fill this important knowledge gap by a longitudinal assessment of the affect of gender-affirming hormone therapy with a detailed characterization using state of the art methods for cardiovascular imaging, circulating biomarker assessment, body composition, and self-reported health-related quality of life. The information obtained will inform both candidates for gender-affirming hormone therapy, their families, health personnel and health policy decision makers about the cardiometabolic effects and cardiovascular risks of such therapy and will be relevant information in shared decision-making processes.

NCT Number	NCT07128771
Lead Sponsor	University Hospital, Akershus Collaborators: Oslo University Hospital, University of Oslo
Conditions	Gender Incongruence, Cardiovascular Disease (CVD) Risk Factors
Enrollment	450 participants
Start Date	2025-09-05
Primary Completion	2027-08 (estimated)
Study Completion	2030-10 (estimated)
Updated on ClinicalTrials.gov	2026-01-12