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Набор по приглашению NCT07128771

Cardiomodulatory Effects of Gender-Affirming Hormone Therapy

— Наблюдательное Gender Incongruence Cardiovascular Disease (CVD) Risk Factors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Gender Incongruence, Cardiovascular Disease (CVD) Risk Factors. Базовые параметры: от 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
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Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Change in left ventricular mass (g) [Срок оценки: 6-12 months]
Вторичные конечные точки (12)
  • Change in left ventricular end-systolic volume (LVES) and end-diastolic volume (EDV) (mL) [Срок оценки: 6-12 months]
  • Change in left ventricle ejection fraction (LVEF) (%) [Срок оценки: 6-12 months]
  • Change in concentration of circulating cardiac biomarkers [Срок оценки: 6-12 months]
  • Change in concentration in markers of blood lipids [Срок оценки: 6-12 months]
  • Change in concentration in markers of cardiometabolic risk factors such as insulin resistance [Срок оценки: 6-12 months]
  • Changes in global longitudinal strain (GLS) (%) and global circumferential strain (GCS) (%) [Срок оценки: 6-12 months]
  • Change in arterial stiffness assessed as the pulse wave velocity (m/s) [Срок оценки: 6-12 months]
  • Change in arterial stiffness assessed as the aortic distensibility (mmHg-1) [Срок оценки: 6-12 months]
  • Change in blood pressure (mmHg) [Срок оценки: 6-12 months]
  • Change in body mass index (BMI) [Срок оценки: 6-12 months.]
  • Change in body composition [Срок оценки: 6-12 months.]
  • Change in self-reported health-related quality of life (SF-36) [Срок оценки: 6-12 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

\- 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Норвегия · 1 центр
  • Oslo University Hospital — Oslo

Идентификаторы

NCT: NCT07128771 · 522599

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗