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临床试验/NCT03078829
NCT03078829终止不适用

The Relation of GnRH Treatment to QTc Interval in Transgender Female Youth: A Time Series Study

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
change in QTc Interval

研究概览

简要总结

Background: The QT interval of the electrocardiogram (ECG), corrected for heart rate (QTc), is a measure of the duration of ventricular repolarization and is a widely used marker of ventricular arrhythmia risk. Testosterone has a shortening effect on QTc length, and the QTc interval in males is shorter than in females after the onset of puberty. Transgender female adolescents are treated with GnRH agonists or spironolactone that suppress endogenous testosterone secretion and might increase the QT interval sufficiently to increase the risk for malignant ventricular arrhythmias. There are no current guidelines regarding monitoring QTc interval in transgender females undergoing GnRH agonist treatment.

Objective: To assess the effect of GnRH agonist treatment on QTc interval in transfemale youth.

Methods: A quasi-experimental time series study of transgender female adolescent, seen at UCSF Child and Adolescent Gender Center (CAGC) during 2017-2019.

Specific aims:

To assess the impact of GnRH agonist treatment on QTc interval length in transgender female adolescent

详细描述

This study is a quasi-experimental time series study, designed to examine the relation between GnRH agonist treatment for 6 months in transgender female youth and electrocardiographic change in QTc interval. Study subjects will be identified when visiting the UCSF Child and Adolescent Gender Center (CAGC). A baseline electrocardiogram (ECG) will be obtained in clinic before initiation of GnRH agonist treatment and at the 6 months follow up appointment.

Sampling scheme: Consecutive sample of transfemale patients presenting to UCSF CAGC (Child and Adolescent Gender Center) clinics meeting entry criteria, who consent to participate in this study

Recruitment strategy: The investigators will approach all transfemale patients with pubertal Tanner stage 4-5 who are ready to start GnRH agonist. From past experience in CAGC clinic, willingness of patients to participate in studies is high. The investigators plan that ECG will be available at clinic visits to further assist recruitment.

Retention strategy: Patients that are being treated in CAGC clinic are followed up every 3 months. Patients are very compliant with clinic visits as patients are eager to complete their transition. ECG is planned to be available at the 6 months clinic follow up visit.

Measurements: The investigators will assess QTc interval using a standard 12-lead ECG. The investigators will also measure serum levels of calcium, potassium and magnesium to rule out electrolyte abnormalities as a cause for QTc interval change, and testosterone, estradiol, LH and FSH levels to assess GnRH agonist effect. The laboratory analytes will be measured using standard procedures in place at the UCSF Laboratory, which is certified by Centers for Medicare and Medicaid Services, the California Department of Health Services, and the College of American Pathologists.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Transgender males to females in pubertal stage Tanner stage 4-5
  • starting GnRH agonist treatment

排除标准

  • Heart disease or arrhythmias at base line
  • Electrolyte abnormalities at baseline (abnormal serum levels of calcium, potassium or magnesium)
  • Failure to obtain informed consent from a parent or guarding or informed assent from a youth.

研究组 & 干预措施

Trans female adolescents

All transgender males to females youth in pubertal stage Tanner stage 4-5, starting GnRH agonist and estrogen treatment

干预措施: Treatment with a GnRh agonists (Drug)

结局指标

主要结局

change in QTc Interval

时间窗: 6 months

A 12-lead ECG will be performed using standardized inspected equipment, at baseline and after 6 months of treatment, difference in milliseconds will be calculates

次要结局

  • QTc interval > 450 milliseconds(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen Rosenthal

Professor of Pediatrics

University of California, San Francisco

研究点 (1)

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