Cardiomodulatory Effects of Gender-Affirming Hormone Therapy

Not yet recruiting

• Conditions: Gender Incongruence; Cardiovascular Disease (CVD) Risk Factors

• Registration Number: NCT07128771
• Lead Sponsor: University Hospital, Akershus

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 the current 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 we 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.

Study Timeline

• Study First Submitted: 2025-05-30
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study Start: 2025-08-15
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Primary Completion: 2027-08
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in left ventricular mass (g)	6-12 months	Assessed by cardiac magnetic resonance (CMR) from baseline to end of study.

Secondary Outcome Measures

Name	Time	Method
Change in left ventricular end-systolic volume (LVES) and end-diastolic volume (EDV) (mL)	6-12 months	Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study.
Change in left ventricle ejection fraction (LVEF) (%)	6-12 months	Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study.
Change in concentration of circulating cardiac biomarkers	6-12 months	Cardiac biomarkers defined as cardiac troponins I and T measured by high sensitivity assays (hs-TnI and hs-TnT) (ng/L) and N-terminal proB-type natriuretic peptide (NT-proBNP) (ng/L), compared from baseline to end of study.
Change in concentration in markers of blood lipids	6-12 months	Blood samples will be collected and assessed from baseline to end of study. Blood samples will include markers such as cholesterol, LDL, and HDL (mmol/L).
Change in concentration in markers of cardiometabolic risk factors such as insulin resistance	6-12 months	Blood samples will be collected and assessed from baseline to end of study. Blood samples will include the marker HbA1c (mmol/mol).
Changes in global longitudinal strain (GLS) (%) and global circumferential strain (GCS) (%)	6-12 months	Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study.
Change in arterial stiffness assessed as the pulse wave velocity (m/s)	6-12 months	Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study.
Change in arterial stiffness assessed as the aortic distensibility (mmHg-1)	6-12 months	Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study.
Change in blood pressure (mmHg)	6-12 months	Blood pressure, both systolic and diastolic blood pressure, will be measured in a standardized manner.
Change in body mass index (BMI)	6-12 months.	Weight and height will be measured in a standarized manner and calculated into BMI (kg/m2).
Change in body composition	6-12 months.	Body composition will be evaluated using dual-energy x-ray absorptiometry (DXA).
Change in self-reported health-related quality of life (SF-36)	6-12 months	For participants aged 18 years or older, the questionnaires SF-36 will be used.
Change in self-reported health-related quality of life (PedsQL)	6-12 months	For patients aged 16-18, the questionnaire PedsQL will be used.
Change in self-reported health-related quality of life (GHQ-12)	6-12 months	For participants aged 18 years or older, the questionnaires GHQ-12 will be used.
Change in self-reported health-related quality of life (SDQ)	6-12 months	For participants aged 16-18 years of age, the questionnaire SDQ will be used.
Change in self-reported health-related quality of life (Chalders Fatigue Questionnaire)	6-12 months	For all participants, the questionnaire Chalders Fatigue Questionnaire will be used.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway