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临床试验/NCT02563379
NCT02563379Unknown不适用

Association Between Circadian Blood Pressure Patterns With Asymptomatic Episodes of Paroxysmal Atrial Fibrillation in Hypertensive Subjects

Evangelismos Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Association between nighttime BP patterns and/or early morning surge with the development of asymptomatic episodes of paroxysmal atrial fibrillation in hypertensive subjects

研究概览

简要总结

The goals of our study are to determine a).the association between abnormal circadian BP and the development of paroxysmal AF in hypertensive patients, b).at which level of TOD, paroxysmal AF episodes are detected in hypertensive subjects, c).if there is any association between systolic and/or diastolic BP levels with AF occurrence, d).whether the mean heart rate during a 24-hr interval is associated with the development of paroxysmal AF, and finally e).examine the relationship between a wide PP and asymptomatic AF episodes in patients with HTN.

详细描述

Atrial fibrillation, also known as AF or Afib, is an abnormal and irregular heart rhythm in which electrical signals are generated chaotically throughout the upper chambers (atria) of the heart. According to the NICE clinical guidelines, a patient who experiences recurrent (two or more) AF episodes that terminate spontaneously without any treatment in less than seven days, and usually within 48 hours is classified as having paroxysmal AF. It has been shown that paroxysmal AF comprises approximately between 25% and 62% of cases of AF, and it is estimated that both its incidence and prevalence are likely to rise as the worldwide population ages dramatically over the next twenty years. Interestingly, hospitalizations due to AF have increased sharply in the US during the last decade, posing thereby a heavy economic burden on the health care system and society.

Likewise, hypertension (HTN) also constitutes a major public health problem globally, and its prevalence is set to increase owing to widespread population ageing. This epidemiological trend is especially prevalent in rapidly developing countries where early routine screening at any point of health care is underutilized among risk subjects, due to several perceived barriers. Moreover, HTN awareness is critical for optimal BP control since under-diagnosis, under-treatment and/or un-treatment of high BP levels can have deleterious effects on the cardiovascular system. In addition, HTN is the single most important risk factor for cerebrovascular stroke, and it has been clearly demonstrated that it is also associated with structural and functional changes in the myocardium that favor the development of AF, further increasing the risk of thromboembolism. Among those alterations, left ventricular hypertrophy (LVH), impaired ventricular filling, left atrial enlargement and slowing of atrial conduction velocity have been identified as important heralds of cardiovascular morbidity and mortality. More specifically, since HTN and AF are two conditions that often co-exist, especially in patients with advanced age, the risk for considerable morbidity and mortality is increased even more, which points towards the significance that optimal BP control holds in the prevention of cardiovascular events. To our knowledge, in the Framingham Heart Study, after controlling for age and other predisposing conditions, HTN and diabetes emerged as the only cardiovascular risk factors predicting AF.

It has also been suggested that nocturnal HTN and non-dipping of BP during sleep are distinct entities that often occur together and are regarded as important harbingers of poor cardiovascular prognosis. Recently, Pierdomenico et al., showed that non-dipper sustained hypertensives have a two-fold greater risk of developing AF than dipper ones. This may be due to the fact that nighttime HTN may be a powerful determinant of long-standing left ventricular diastolic dysfunction, which subsequently increases atrial stretch. Furthermore, it has been observed that nighttime hemodynamics, are associated with higher sympathetic and reduced vagal activity, which may trigger AF. Additionally, sympathetic activation is associated with the stimulation of the renin-angiotensin-aldosterone axis (RAAA), which leads to increased left ventricular diastolic preload, both atrial and ventricular fibrosis, exerting thus direct cellular electrophysiological effects. Besides, scientists suggested that nighttime HTN is better associated with cardiovascular target organ damage (TOD) as compared with the non-dipping pattern.

According to the most recent guidelines of the ESH, the presence of microalbuminuria, increased pulse wave velocity, LVH on echocardiogram and carotid plaques detected during carotid ultrasonography, constitute markers of asymptomatic organ damage and it has been clearly demonstrated from multiple studies that they can predict CV mortality independently of SCORE stratification.

In our study we will try to investigate whether abnormalities in the circadian rhythm of BP (such as extreme dipping or non-dipping pattern, and/or morning surge) in hypertensive subjects with or without TOD are associated with the development of new-onset paroxysmal AF.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with essential HTN (office BP>140/90mmHg) or patients receiving at least one antihypertensive medication (ie. RAAA inhibitors or diuretic), aged 18-85 years of age.
  • Patients with at least one of the following risk factors, organ damage or other evidence of cardiovascular disease:
  • Previous stroke
  • Transient ischemic attack (TIA)
  • Systemic embolism
  • Diabetes mellitus type 2
  • Obstructive sleep apnea (OSA)
  • Dyslipidemia
  • History of coronary artery disease (CAD)
  • Valvular heart disease (VHD)
  • Echocardiographic findings attributed to HTN (ie. diastolic dysfunction, LVH)
  • White coat hypertension (WCH), masked hypertension (MH)
  • Positive family history for rhythm disturbances

排除标准

  • Patients already diagnosed with paroxysmal or permanent AF
  • Severe renal insufficiency (eGFR according to MDRD formula <25ml/min/1.73m2)
  • Patients unable to attend follow-up visits
  • Clinical evidence of severe heart failure
  • Suspected secondary HTN
  • Mental disorders
  • Patients with cancer

结局指标

主要结局

Association between nighttime BP patterns and/or early morning surge with the development of asymptomatic episodes of paroxysmal atrial fibrillation in hypertensive subjects

时间窗: 12 months

• To investigate whether nighttime BP patterns (extreme dipping, normal dipping or reduced dipping and non-dipping including risers) or early morning surge are associated with the detection of paroxysmal AF in hypertensive subjects.

次要结局

  • Association between SBP and/or DBP levels with the development of paroxysmal AF in hypertensive patients(12 months)
  • Association between the degree of TOD and the development of paroxysmal AF in hypertensive patients(12 months)
  • Association between PP and the development of asymptomatic paroxysmal AF episodes(12 months)
  • Association between office heart rate or mean 24-hr heart rate with the development of asymptomatic paroxysmal AF episodes.(12 months)

研究者

发起方
Evangelismos Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emmanuel A. Andreadis

HEAD OF THE FOURTH INTERNAL MEDICINE DEPARTMENT

Evangelismos Hospital

研究点 (1)

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