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临床试验/NCT00295542
NCT00295542已完成4 期

Prognostic Value of Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy in Relation to Risk (the MAPEC Study).

University of Vigo1 个研究点 分布在 1 个国家目标入组 3,344 人开始时间: 2000年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
3,344
试验地点
1
主要终点
Prognostic value of ABPM, impact of changes in ambulatory BP and impact of circadian time of antihypertensive treatment in cardiovascular, cerebrovascular and renal risk assessment.

研究概览

简要总结

The MAPEC study was designed to investigate whether normalizing the circadian blood pressure profile towards a more dipper pattern (increasing the diurnal/nocturnal ratio of blood pressure) by the use of Chronotherapy (that is, taking into account the time of day of administration of antihypertensive medications) reduces cardiovascular risk.

详细描述

Target organ damage is more closely associated with ambulatory (ABPM) than with clinic blood pressure (BP). In particular, the reduction of the normal 10 to 20% sleep-time BP decline (non-dipper pattern) is associated with elevated risk of end-organ injury, particularly to the heart, brain and kidney. These results suggest that cardiovascular risk could be influenced not by BP elevation alone, but also by the magnitude of the circadian BP variability. Moreover, at least two independent prospective studies have suggested that nighttime BP is a better predictor of risk than daytime BP. Common to all previous trials is that prognostic significance of ABPM has relied on a single baseline profile from each participant, without accounting for possible changes in the BP pattern, mainly associated to antihypertensive therapy and aging during follow-up. The MAPEC study investigates, first, the comparative prognostic value of several BP parameters (including, among many others, BP variability, the diurnal/nocturnal ratio, diurnal and nocturnal means, slope of morning rise, etc) in the prediction of cardiovascular morbidity and mortality; and, second, whether potential changes in the circadian BP pattern after Chronotherapy with antihypertensive drugs are associated to changes in cardiovascular risk.

研究设计

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

入排标准

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

入选标准

  • Essential hypertension

排除标准

  • shift workers
  • secondary hypertension
  • intolerant to ABPM

研究组 & 干预措施

1

Active Comparator

Treatment on awakening

干预措施: Ambulatory blood pressure monitoring (Device)

1

Active Comparator

Treatment on awakening

干预措施: Chronotherapy, timing of antihypertensive medication (Procedure)

1

Active Comparator

Treatment on awakening

干预措施: ACEI (including spirapril, enalapril, quinapril, lisinopril) (Drug)

1

Active Comparator

Treatment on awakening

干预措施: ARB (including valsartan, telmisartan, olmesartan) (Drug)

1

Active Comparator

Treatment on awakening

干预措施: beta blockers (including nebivolol, atenolol, carvedilol) (Drug)

1

Active Comparator

Treatment on awakening

干预措施: diuretics (torasemide, indapamide, HTCZ) and doxazosin (Drug)

1

Active Comparator

Treatment on awakening

干预措施: Combination therapy in essential hypertension (Procedure)

2

Active Comparator

Treatment at bedtime

干预措施: Ambulatory blood pressure monitoring (Device)

2

Active Comparator

Treatment at bedtime

干预措施: Chronotherapy, timing of antihypertensive medication (Procedure)

2

Active Comparator

Treatment at bedtime

干预措施: ACEI (including spirapril, enalapril, quinapril, lisinopril) (Drug)

2

Active Comparator

Treatment at bedtime

干预措施: ARB (including valsartan, telmisartan, olmesartan) (Drug)

2

Active Comparator

Treatment at bedtime

干预措施: beta blockers (including nebivolol, atenolol, carvedilol) (Drug)

2

Active Comparator

Treatment at bedtime

干预措施: diuretics (torasemide, indapamide, HTCZ) and doxazosin (Drug)

2

Active Comparator

Treatment at bedtime

干预措施: Combination therapy in essential hypertension (Procedure)

结局指标

主要结局

Prognostic value of ABPM, impact of changes in ambulatory BP and impact of circadian time of antihypertensive treatment in cardiovascular, cerebrovascular and renal risk assessment.

时间窗: Five years

次要结局

  • Influence of circadian time of antihypertensive treatment in BP control and the remodeling of the circadian BP pattern of hypertensive patients.(Five years)
  • Prevalence of an altered BP profile as a function of the circadian time of treatment.(Five years)

研究者

发起方
University of Vigo
申办方类型
Other

研究点 (1)

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