Cardiomodulatory Effects of Gender-Affirming Hormone Therapy

NCT07128771 | Enrolling By Invitation

• 1 other identifier: 522599
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender Incongruence; Cardiovascular Disease (CVD) Risk Factors

Keywords

gender incongruence; gender dysphoria; cardiovascular disease; troponin; NT-proBNP; proteomics; CMR; heart disease; blood pressure; echocardiography; sex hormones; cardiometabolic

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular mass (g)

  Assessed by cardiac magnetic resonance (CMR) from baseline to end of study.

  6-12 months

Secondary Outcomes (16)

• Change in left ventricular end-systolic volume (LVES) and end-diastolic volume (EDV) (mL)

  6-12 months

• Change in left ventricle ejection fraction (LVEF) (%)

  6-12 months

• Change in concentration of circulating cardiac biomarkers

  6-12 months

• Change in concentration in markers of blood lipids

  6-12 months

• Change in concentration in markers of cardiometabolic risk factors such as insulin resistance

  6-12 months

Study Arms (2)

Patients receiving gender-affirming hormone therapy

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

Control group

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients approved for gender-affirming hormone therapy by an endocrinologist at Oslo University Hospital.

You may qualify if:

• 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

You may not qualify if:

• \- History of clinically significant cardiovascular disease
• No daily smokers
• No endocrine disorders
• No daily medications (except contraception and seasonal medication such as antihistamines)

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Oslo University Hospital: collaborator
• University of Oslo: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected at each visit (EDTA-plasma, heparin-plasma and serum).

MeSH Terms

Conditions

Gender Dysphoria; Cardiovascular Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Torbjørn Omland, MD, PhD, MPH

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: August 19, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2030
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)