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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| University of Oslo | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular mass (g) | Assessed by cardiac magnetic resonance (CMR) from baseline to end of study. | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular end-systolic volume (LVES) and end-diastolic volume (EDV) (mL) | Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study. | 6-12 months |
| Change in left ventricle ejection fraction (LVEF) (%) |
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Inclusion Criteria:
Exclusion Criteria:
- History of clinically significant cardiovascular disease
For the healthy controls, these exclusion criteria also apply:
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Patients approved for gender-affirming hormone therapy by an endocrinologist at Oslo University Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Torbjørn Omland, MD, PhD, MPH | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Oslo | Norway |
This is due to data protection considerations.
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| ID | Term |
|---|---|
| D000068116 | Gender Dysphoria |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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Blood samples will be collected at each visit (EDTA-plasma, heparin-plasma and serum).
Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study. |
| 6-12 months |
| Change in concentration of circulating cardiac biomarkers | 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. | 6-12 months |
| Change in concentration in markers of blood lipids | 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). | 6-12 months |
| Change in concentration in markers of cardiometabolic risk factors such as insulin resistance | Blood samples will be collected and assessed from baseline to end of study. Blood samples will include the marker HbA1c (mmol/mol). | 6-12 months |
| Changes in global longitudinal strain (GLS) (%) and global circumferential strain (GCS) (%) | Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study. | 6-12 months |
| Change in arterial stiffness assessed as the pulse wave velocity (m/s) | Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study. | 6-12 months |
| Change in arterial stiffness assessed as the aortic distensibility (mmHg-1) | Assessed by cardiac magnetic resonance (CMR) and echocardiography from baseline to end of study. | 6-12 months |
| Change in blood pressure (mmHg) | Blood pressure, both systolic and diastolic blood pressure, will be measured in a standardized manner. | 6-12 months |
| Change in body mass index (BMI) | Weight and height will be measured in a standarized manner and calculated into BMI (kg/m2). | 6-12 months. |
| Change in body composition | Body composition will be evaluated using dual-energy x-ray absorptiometry (DXA). | 6-12 months. |
| Change in self-reported health-related quality of life (SF-36) | 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. | 6-12 months |
| Change in self-reported health-related quality of life (PedsQL) | 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. | 6-12 months |
| Change in self-reported health-related quality of life (GHQ-12) | 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. | 6-12 months |
| Change in self-reported health-related quality of life (SDQ) | 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. | 6-12 months |
| Change in self-reported health-related quality of life (Chalders Fatigue Questionnaire) | 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. | 6-12 months |