Cardiomodulatory Effects of Gender-Affirming Hormone Therapy

NCT ID: NCT07128771

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-05
• Study Completion Date: 2030-10-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients receiving gender-affirming hormone therapy

Patients receiving gender-affirming hormone therapy at Oslo University Hospital with a diagnosis of gender-incongruence

No interventions assigned to this group

Control group

Age-matched participants not receiving gender-affirming hormone therapy without the diagnosis of gender-incongruence

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Diagnosis of gender-incongruence
• Scheduled to initiate gender-affirming hormone therapy at Oslo University Hospital or currently being followed by an endocrinologist for gender-affirming hormone therapy at Oslo University Hospital
• Being 16 years or older

Exclusion Criteria

• History of clinically significant cardiovascular disease

• No daily smokers
• No endocrine disorders
• No daily medications (except contraception and seasonal medication such as antihistamines)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Torbjorn Omland

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Torbjørn Omland, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

Oslo University Hospital

Oslo, Oslo County, Norway

Countries

Norway

Other Identifiers

522599

Identifier Type: -

Identifier Source: org_study_id