NCT04932135已完成不适用
Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年6月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- resting heart rate
研究概览
简要总结
The investigators want to investigate if a continuous heart rate monitoring with a wrist worn fitnesstracker can be useful in the treatment and surveillance of patients suffering from Graves' disease.The aim of our research project is two-fold: First, to evaluate the use of continuous heart rate monitoring as a potential substitute for hormone measurements during treatment of hyperthyroidism. Second, to use continuous heart rate monitoring as a tool for early detection of relapse after discontinuation of antithyroid drugs.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants:
- •BMI 17 to 35 kg/m2
- •Diagnosis of Graves' disease (matching one of the following criteria: elevated TRAb and/or ultrasonography and functional imaging consistent with Graves' disease)
- •In possession of a smart phone
- •Able to use a wearable device and willing to regularly upload their biometric data
- •Informed consent as documented by signature (Appendix Informed Consent Form)
- •Group "treatment":
- •TSH < 0.2 mIU/l and
- •fT4 > 25 pM or fT3 > 8 pM
- •ATD planned, additional treatment with propranolol allowed
- •Group "surveillance":
- •TSH within the reference range between 0.3 and 4.5 mlU/l
- •Cessation of ATD is planned within the next 2-4 weeks
排除标准
- •Chronic treatment with beta blocker or verapamil-type calcium antagonist for other reason than symptomatic treatment of hyperthyroidism (propranolol)
- •Treatment with amiodarone
- •Pacemaker with continuous stimulation.
- •Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
- •Abuse of alcohol or illicit drugs
- •Allergic to nickel or silicone
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
结局指标
主要结局
resting heart rate
时间窗: four months
continuous resting heart rate measurement with fitnesstracker in relation to the thyroid hormone levels in patients during and after treatment with anti-thyroid drugs.
次要结局
未报告次要终点
研究者
研究点 (1)
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