Title
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).
Phase
Phase 4Lead Sponsor
University of VigoStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HypertensionIntervention/Treatment
atenolol enalapril indapamide nebivolol olmesartan valsartan torsemide carvedilol spirapril doxazosin hydrochlorothiazide telmisartan lisinopril quinapril ...Study Participants
3344The 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.
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.
Sampling at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours
Comparison of effects of awakening versus bedtime dosing
Treatment at awakening versus bedtime
Treatment at awakening versus bedtime
Treatment at awakening versus bedtime
Treatment at awakening versus bedtime
Treatment at awakening versus bedtime
Treatment on awakening
Treatment at bedtime
Inclusion Criteria: Essential hypertension Exclusion Criteria: AIDS shift workers secondary hypertension intolerant to ABPM