Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy
Information source: University of Vigo
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Ambulatory blood pressure monitoring (Device); Chronotherapy, timing of antihypertensive medication (Procedure); ACEI (including spirapril, enalapril, quinapril, lisinopril) (Drug); ARB (including valsartan, telmisartan, olmesartan) (Drug); beta blockers (including nebivolol, atenolol, carvedilol) (Drug); diuretics (torasemide, indapamide, HTCZ) and doxazosin (Drug); Combination therapy in essential hypertension (Procedure)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of Vigo
Official(s) and/or principal investigator(s):
Ramon C Hermida, PhD, Principal Investigator, Affiliation: University of Vigo
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.
Official title: Prognostic Value of Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy in Relation to Risk (the MAPEC Study).
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
circadian pattern of blood pressure determined by ambulatory monitoring
cardiovascular and cerebrovascular events per year of follow-up
total cardiovascular mortality per year of follow-up
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Essential hypertension
- shift workers
- secondary hypertension
- intolerant to ABPM
Locations and Contacts
Hypertension Unit, Hospital Clinico Universitario, Santiago de Compostela 15706, Spain
Starting date: March 2002
Ending date: March 2010
Last updated: April 21, 2008