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Enrolling by Invitation

NCT Number: NCT07128771

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.

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Key information

Conditions

Gender Incongruence Cardiovascular Disease (CVD) Risk Factors Cardiovascular Diseases Gender Dysphoria Heart Diseases Mental Disorders Sexual Dysfunctions, Psychological

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

For the healthy controls, these exclusion criteria also apply:

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

Treatment and study plan

Primary outcomes

  1. Change in left ventricular mass (g)

    Time frame: 6-12 months

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

Secondary outcomes

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

    Time frame: 6-12 months

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

  2. Change in left ventricle ejection fraction (LVEF) (%)

    Time frame: 6-12 months

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

  3. Change in concentration of circulating cardiac biomarkers

    Time frame: 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.

  4. Change in concentration in markers of blood lipids

    Time frame: 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).

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

    Time frame: 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).

  6. Changes in global longitudinal strain (GLS) (%) and global circumferential strain (GCS) (%)

    Time frame: 6-12 months

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

  7. Change in arterial stiffness assessed as the pulse wave velocity (m/s)

    Time frame: 6-12 months

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

  8. Change in arterial stiffness assessed as the aortic distensibility (mmHg-1)

    Time frame: 6-12 months

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

  9. Change in blood pressure (mmHg)

    Time frame: 6-12 months

    Blood pressure, both systolic and diastolic blood pressure, will be measured in a standardized manner.

  10. Change in body mass index (BMI)

    Time frame: 6-12 months.

    Weight and height will be measured in a standarized manner and calculated into BMI (kg/m2).

  11. Change in body composition

    Time frame: 6-12 months.

    Body composition will be evaluated using dual-energy x-ray absorptiometry (DXA).

  12. Change in self-reported health-related quality of life (SF-36)

    Time frame: 6-12 months

    For participants aged 18 years or older, the questionnaires SF-36 will be used. SF-36 gives eight scaled scores, each ranging from 0 to 100. Higher scores indicates better health-related quality of life.

  13. Change in self-reported health-related quality of life (PedsQL)

    Time frame: 6-12 months

    For patients aged 16-18, the questionnaire PedsQL will be used. Each question is scored 0-4 and each item response is linearly transformed to a 0-100 scale where higher scores indicate better health-related quality of life.

  14. Change in self-reported health-related quality of life (GHQ-12)

    Time frame: 6-12 months

    For participants aged 18 years or older, the questionnaires GHQ-12 will be used. The scale goes from 0 to 36 (Likert Method) with higher values indicating greater psychological stress.

  15. Change in self-reported health-related quality of life (SDQ)

    Time frame: 6-12 months

    For participants aged 16-18 years of age, the questionnaire SDQ will be used. The scale goes from 0 to 50 with higher values indicating increasing symptoms of difficulties.

  16. Change in self-reported health-related quality of life (Chalders Fatigue Questionnaire)

    Time frame: 6-12 months

    For all participants, the questionnaire Chalders Fatigue Questionnaire will be used. The scale goes from 0 to 33 with higher values indicating increasing symptoms of fatigue.

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Oslo University Hospital
  • University of Oslo

Registry information

Acronym: CARMEN

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Aug 19, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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