NCT07128771

Cardiomodulatory Effects of Gender-Affirming Hormone Therapy

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: University Hospital, Akershus · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The aim of this study is using a prospective and cross-sectional observational design, to assess the effect of initiation and effect of gender-affirming hormone therapy in trans men (female to male) and in trans women (male to female) on: * Cardiovascular risk factors, including blood pressure, body mass index, body composition, and blood lipids * Cardiovascular function, structure and anatomy as assessed by cardiovascular magnetic resonance (CMR) imaging and transthoracic echocardiography * Circulating cardiovascular and inflammatory biomarkers assessed by immunoassays and proteomic profiling * Self-reported health-related quality of life. The study will have one longitudinal group where 60 trans women and 60 trans men are followed from the start of treatment till 6-12 months after. An age-matched control group will go through the same assessments. The second part of the study will be cross-sectional, where the investigators aim to include 100 trans women and 100 trans men already on gender-affirming hormone therapy and being followed at Oslo University Hospital by an endocrinologist. In both these group, patients who both previously or currently are using Gonadotropin-releasing hormone agonists (GnRH-agonists), so called puberty blockers, will also be eligible for inclusion.

Conditions

• Gender Incongruence
• Cardiovascular Disease (CVD) Risk Factors

Timeline

• Start date: 2025-09-05
• Primary completion: 2027-08-01
• Completion: 2030-10-01
• First posted: 2025-08-19
• Last updated: 2026-01-12

Locations

1 site across 1 country: Norway