NCT00295542

Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,344 (actual)
• Sponsor: University of Vigo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Ambulatory blood pressure monitoring	Sampling at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
PROCEDURE	Chronotherapy, timing of antihypertensive medication	Comparison of effects of awakening versus bedtime dosing
DRUG	ACEI (including spirapril, enalapril, quinapril, lisinopril)	Treatment at awakening versus bedtime
DRUG	ARB (including valsartan, telmisartan, olmesartan)	Treatment at awakening versus bedtime
DRUG	beta blockers (including nebivolol, atenolol, carvedilol)	Treatment at awakening versus bedtime
DRUG	diuretics (torasemide, indapamide, HTCZ) and doxazosin	Treatment at awakening versus bedtime
PROCEDURE	Combination therapy in essential hypertension	Treatment at awakening versus bedtime

Timeline

• Start date: 2000-03-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2006-02-23
• Last updated: 2009-04-28

Locations

1 site across 1 country: Spain