Cardiomodulatory Effects of Gender-Affirming Hormone Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Change in left ventricular mass (g)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •- 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)
研究组 & 干预措施
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
结局指标
主要结局
Change in left ventricular mass (g)
时间窗: 6-12 months
Assessed by cardiac magnetic resonance (CMR) from baseline to end of study.
次要结局
- Change in blood pressure (mmHg)(6-12 months)
- Change in body composition(6-12 months.)
- Change in self-reported health-related quality of life (PedsQL)(6-12 months)
- Change in self-reported health-related quality of life (GHQ-12)(6-12 months)
- 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 self-reported health-related quality of life (SF-36)(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)
- Change in arterial stiffness assessed as the aortic distensibility (mmHg-1)(6-12 months)
- Changes in global longitudinal strain (GLS) (%) and global circumferential strain (GCS) (%)(6-12 months)
- Change in arterial stiffness assessed as the pulse wave velocity (m/s)(6-12 months)
- Change in body mass index (BMI)(6-12 months.)
- Change in self-reported health-related quality of life (SDQ)(6-12 months)
- Change in self-reported health-related quality of life (Chalders Fatigue Questionnaire)(6-12 months)
研究者
Torbjorn Omland
Professor
University Hospital, Akershus