Prognostic Value of Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy in Relation to Risk (the MAPEC Study).
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
- 是
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
Treatment on awakening
干预措施: Ambulatory blood pressure monitoring (Device)
1
Treatment on awakening
干预措施: Chronotherapy, timing of antihypertensive medication (Procedure)
1
Treatment on awakening
干预措施: ACEI (including spirapril, enalapril, quinapril, lisinopril) (Drug)
1
Treatment on awakening
干预措施: ARB (including valsartan, telmisartan, olmesartan) (Drug)
1
Treatment on awakening
干预措施: beta blockers (including nebivolol, atenolol, carvedilol) (Drug)
1
Treatment on awakening
干预措施: diuretics (torasemide, indapamide, HTCZ) and doxazosin (Drug)
1
Treatment on awakening
干预措施: Combination therapy in essential hypertension (Procedure)
2
Treatment at bedtime
干预措施: Ambulatory blood pressure monitoring (Device)
2
Treatment at bedtime
干预措施: Chronotherapy, timing of antihypertensive medication (Procedure)
2
Treatment at bedtime
干预措施: ACEI (including spirapril, enalapril, quinapril, lisinopril) (Drug)
2
Treatment at bedtime
干预措施: ARB (including valsartan, telmisartan, olmesartan) (Drug)
2
Treatment at bedtime
干预措施: beta blockers (including nebivolol, atenolol, carvedilol) (Drug)
2
Treatment at bedtime
干预措施: diuretics (torasemide, indapamide, HTCZ) and doxazosin (Drug)
2
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)
