Persistent Cardiac Symptoms in Patients With Adequately Treated Graves' Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Cardiac changes
研究概览
简要总结
Hyperthyroidism is a condition with increased production of thyroid hormone from the thyroid gland. Hyperthyroidism affects the heart's inotropy (contractile force) and chronotropy (rhythm). Therefore, patients often experience symptoms such as increased/irregular heart rate, pounding heartbeats, and shortness of breath. The cardiac symptoms often improve when hyperthyroidism is treated and biochemical euthyroidism is achieved. However, knowledge of the long-term effects on the heart is limited. Existing studies have generally shown that patients with hyperthyroidism have an increased morbidity and mortality.
The investigators conducted a questionnaire survey which showed that about 38% of patients with Graves' disease continue to experience cardiac symptoms even months after normalization of thyroid hormone concentrations in the blood. This observation supports the presence of a persistent cardiovascular dysfunction, which may be due to a modulation of genomic or non-genomic factors with an effect on the cardiovascular system. These reflections are the focus of this clinical study. The aim of the study is to investigate the possible pathophysiology for this new "syndrome" in biochemically euthyroid patients. It is not a repetition of previous similar experiments.
详细描述
Cardiac symptoms are common i patients with Graves' disease. These symptoms often disappear when hyperthyroidism is treated. However, a subgroup of patients with Graves' disease experiences persisting cardiac symptoms after treatment. The aim of the study is to describe these symptoms and investigate their origin.
A total of 75 patients are included in the study. Patients were recruited from the Department of Nephrology and Endocrinology at Copenhagen University Hospital Rigshospitalet and the Department of Internal Medicine, Section of Endocrinology at Herlev Gentofte Hospital, Denmark. The patients were identified by extracting a list of patients with the International Classification of Diseases 10 codes (ICD 10 codes) E050 and E059. Also, a list of patients with positive thyrotropin receptor antibody (TRAbI measurements was extracted.
All patients had a thorough cardiac work up including blood samples, 12-lead resting electrocardiogram, 24-hour electrocardiogram monitoring (Holter), transthoracic echocardiography, and exercise stress test. The focus was to investigate whether the cardiac symptoms could be explained by structural or functional changes of the heart or by cardiac arrhythmias.
All patients were questioned about their symptoms including: type of cardiac symptoms, frequency and when they occured. The focus was to gain knowledge on the clinical presentation of cardiac symptoms in the subgroup.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Graves' disease
- •Between the ages of 18 and 55 years
- •Has been euthyroid for at least three months prior to inclusion
- •Experiences cardiac symptoms
排除标准
- •Cardiovascular disease
- •Deemed unsuitable by project staff (e.g. due to language problems)
- •Pregnancy
- •Alcohol abuse or other abuses
结局指标
主要结局
Cardiac changes
时间窗: The cardiac examinations were performed during three study visits which extended over a period of approximately half a year.
The patients were examined for cardiac arrhythmias and structural and functional changes of the heart with resting 12-lead ECG, 24-hour ambulatory ECG monitoring, transthoracic echocardiography, and exercise stress test. ECG analyses included: heart rate, PR-interval, QRS-duration, and QT-interval. Any presence of abnormal cardiac axis, bundle branch block, atrioventricular (AV) block, ventricular hypertrophy or atrial enlargement was noted. Analysis of the 24-hour ECG recording including heart rate, detection of arrythmia, heart block, and reported symptoms. The echocardiographic analysis consisted of the following measurements: left ventricular dimensions, left ventricular volumes, left ventricular function, left atrial volume, right ventricular dimensions, right ventricular function, and pulmonary artery pressure. Analysis of the exercise stress test included blood pressure, heart rate, and ECG-changes indicating myocardial ischemia and arrhythmias.
次要结局
未报告次要终点
研究者
Ulla Feldt-Rasmussen
MD, DMSc, Professor Emerita, Senior Research Consultant
Rigshospitalet, Denmark