跳至主要内容
临床试验/CTRI/2023/08/057003
CTRI/2023/08/057003招募中不适用

Understanding Circadian Abnormalities in Cardiovascular Diseases and Circadian Regulation of Cardiac Medicines

IIT hyderabad1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年9月17日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
IIT hyderabad
入组人数
300
试验地点
1
主要终点
Altered rhythmicity of physiological and biochemical parameters in cardiovascular-diseased (CVD) patients.

研究概览

简要总结

The central hypothesis of this project is that the circadian clock plays a significant role in cardiac health, and the aberrations in clock machinery could be assessed as a risk factor for cardiovascular diseases. Our research strategy in this project will emphasize elucidating circadian regulation and abnormalities in early-stage (young) and elder CVD patients. We will investigate how diurnal rhythmicity in physiological and biochemical parameters is altered in heart disease patients. In this project, we also intend to illustrate the rhythmicity in the expression of prominent molecular targets for commonly used cardiac medicines to evaluate their possible dosing time dependency (in terms of therapeutic efficacy and side effects).

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adults of either gender (<40 years young group, >40 years older group) suffering from cardiovascular diseases (a narrow age range to avoid age-related circadian variations)
  • Cardiovascular disease diagnosed based on the clinical manifestations and confirmed through an electrocardiogram (ECG)
  • Age and gender (and occupation, if possible) matched healthy participants as control subjects based on medical history, clinical examination, and laboratory investigations
  • Subjects (patients and controls) willing to provide written informed consent and comply with protocol requirements.

排除标准

  • Subjects reluctant to provide written informed consent or to comply with the study protocol
  • Subjects with any significant medical history (ongoing or in the recent past)
  • Currently diagnosed with a neurological or sleep disorder (narcolepsy, obstructive sleep apnea, restless leg syndrome) and/or being prescribed a non-psychotropic medication that can alter sleep and circadian rhythms (such as cortisone)
  • Subjects with severe anemia (Hb level < 7g/dL)
  • Female patients who are pregnant at the time of enrolment
  • Subjects who are chronic alcoholics or smokers.

结局指标

主要结局

Altered rhythmicity of physiological and biochemical parameters in cardiovascular-diseased (CVD) patients.

时间窗: 3 years 6 months

次要结局

  • Optimal time of the day for beta-blocker administration in CVD patients.(3 years 6 months)

研究者

发起方
IIT hyderabad
申办方类型
Research institution

研究点 (1)

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