跳至主要内容
临床试验/NCT02581241
NCT02581241已完成不适用

Abnormal QT-Response to the Sudden Tachycardia Provoked by Standing in Individuals With Drug-induced Long QT Syndrome

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2016年1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
已完成
入组人数
5
试验地点
1
主要终点
ECG measurements of QT before and during stand up test

研究概览

简要总结

The drug-induced long QT syndrome (diLQTS) describes a clinical entity in which administration of a drug produces marked prolongation of the QT interval of the electrocardiogram, associated with the development of a polymorphic ventricular tachycardia, termed torsades de pointes (TdP). The heart rate is an important variable affecting the QT interval. The QT interval normally shortens as the heart rate accelerates; however, the adaptation of the QT interval to sudden heart rate acceleration is not instantaneous. Interestingly, Holter studies show that the speed of response of the QT interval to sudden changes in heart rate (that is, the time it takes the QT interval of a given person to reach a new steady-state QT/RR relation) in healthy persons is highly individual and independent of the basic QTc. The investigators and others recently proposed the "quick standing" test as a simple bedside test that facilitates the diagnosis of congenital LQTS. The test takes advantage of the fact that as one stands up, the heart rate acceleration is abrupt while the associated QT-interval shortening is gradual. As the R-R interval shortens faster than the QT interval, the QT appears to "stretch" toward the next P wave and the corrected QT interval (QTc) for heart rate actually increases momentarily. The phenomenon of "QT stretching" is universal but is exaggerated in patients with LQTS, allowing for a simple but accurate diagnostic test. There is no data on the effects of quick standing on drug-associated form of the long QT syndrome. The investigators therefore propose the present study to better understand who these patients with drug-associated form of the long QT syndrome are and what the significance of their abnormal QT-response is.

详细描述

The drug-induced long QT syndrome (diLQTS) describes a clinical entity in which administration of a drug produces marked prolongation of the QT interval of the electrocardiogram, associated with the development of a polymorphic ventricular tachycardia, termed torsades de pointes (TdP). Drugs that produce diLQTS block the repolarizing current, IKr, encoded by KCNH2, the disease gene for type 2 congenital LQTS (cLQTS) . Some risk factors are drug-specific (pharmacokinetic factors such as cytochrome P450 variants) whereas others (pharmacodynamic factors) seem more related to myocardial sensitivity across drugs. Studies of the congenital syndrome demonstrated variable penetrance in the congenital syndrome; that is, there is variability in the extent to which mutation carriers display long QT intervals, syncope, and sudden death. Thus, one pharmacogenetic hypothesis is that persons displaying diLQTS represent an atypical form of the congenital form of the syndrome. In fact, a minority of subjects with diLQTS have rare mutations in cLQTS disease genes and can thus be labeled as having the congenital syndrome. In a given family, some persons with a LQTS mutation have clearly long QT intervals, whereas others with the same mutation have normal QT intervals at baseline. In some cases, these latter people, often referred to as "latent" or "subclinical" LQTS, experience TdP only after therapy with a QT-prolonging drug. Indeed, when cLQTS disease genes have been screened, mutations are identified in about 10% of subjects with diLQTS. The heart rate is an important variable affecting the QT interval. The QT interval normally shortens as the heart rate accelerates; however, the adaptation of the QT interval to sudden heart rate acceleration is not instantaneous. Animal and clinical studies have shown that following an abrupt increase in ventricular pacing rate, it takes up to 2 minutes until the ventricular refractory period and the QT interval shorten to a new steady state that is appropriate for the new (faster) rate. Interestingly, Holter studies show that the speed of response of the QT interval to sudden changes in heart rate (that is, the time it takes the QT interval of a given person to reach a new steady-state QT/RR relation) in healthy persons is highly individual and independent of the basic QTc. The investigators and others recently proposed the "quick standing" test as a simple bedside test that facilitates the diagnosis of congenital LQTS. The test takes advantage of the fact that as one stands up, the heart rate acceleration is abrupt while the associated QT-interval shortening is gradual. As the R-R interval shortens faster than the QT interval, the QT appears to "stretch" toward the next P wave and the corrected QT interval (QTc) for heart rate actually increases momentarily. The phenomenon of "QT stretching" is universal but is exaggerated in patients with LQTS, allowing for a simple but accurate diagnostic test. There is no data on the effects of quick standing on drug-associated form of the long QT syndrome. The investigators therefore propose the present study to better understand who these patients with drug-associated form of the long QT syndrome are and what the significance of their abnormal QT-response is.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age above 18 years
  • were hospitalized in Tel Aviv medical center between January 2013 and June 2015 due to drug-induced long QT syndrome and the associated torsades de
  • were treated with specific drugs (antibiotics) that potentially prolong the QT interval (only for control group)

排除标准

  • Subjects with an inability to communicate well with the investigators (i.e., language problem, poor mental development or impaired cerebral function).
  • Subjects with any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by Investigator.
  • Subjects who are non-cooperative or unwilling to sign consent form.

研究组 & 干预措施

drug-induced long QT syndrome

Experimental

20 adults aged above 18 years which were hospitalized in Tel Aviv medical center between January 2013 and June 2015 due to drug-induced long QT syndrome and the associated torsades de pointes, have no exclusion criteria and provide informed consent to participate in the study.

Interventions. Participating individuals will be instructed to rest supine for 10 minutes while repeat electrocardiograms are recorded. They will then be instructed to stand up quickly and remain standing still for 10 minutes.

Individuals with inability to stand up quickly will be tested with tilt table test used in our hospital

干预措施: tilt table (Device)

control

Active Comparator

20 adults aged above 18 years which were hospitalized in Tel Aviv medical center between January 2013 and June 2015 and were treated with specific drugs (antibiotics) that potentially prolong the QT interval but they do not have drug-induced long QT syndrome, have no exclusion criteria and provide informed consent to participate in the study.

Interventions. Participating individuals will be instructed to rest supine for 10 minutes while repeat electrocardiograms are recorded. They will then be instructed to stand up quickly and remain standing still for 10 minutes.

Individuals with inability to stand up quickly will be tested with tilt table test used in our hospital

干预措施: tilt table (Device)

结局指标

主要结局

ECG measurements of QT before and during stand up test

时间窗: 12 months

ECG measurements of QT and RR before and during stand up test. measured in msec units

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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