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

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

Primary outcome:

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Essential hypertension

Exclusion Criteria:

- AIDS

- shift workers

- secondary hypertension

- intolerant to ABPM

Hypertension Unit, Hospital Clinico Universitario, Santiago de Compostela 15706, Spain

Starting date: March 2002
Ending date: March 2010
Last updated: April 21, 2008