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

University of Vigo

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: ARB (including valsartan, telmisartan, olmesartan); Drug: diuretics (torasemide, indapamide, HTCZ) and doxazosin; Procedure: Combination therapy in essential hypertension; Drug: ACEI (including spirapril, enalapril, quinapril, lisinopril); Drug: beta blockers (including nebivolol, atenolol, carvedilol); Procedure: Chronotherapy, timing of antihypertensive medication; Device: Ambulatory blood pressure monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT00295542

SAF2006-6254

INCITE07-PXI-322003ES

PGIDIT03-PXIB-32201PR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,344 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Essential hypertension

Exclusion criteria

• AIDS
• shift workers
• secondary hypertension
• intolerant to ABPM

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,344 participants in 2 patient groups

1

Active Comparator group

Description:

Treatment on awakening

Treatment:

Procedure: Combination therapy in essential hypertension

Drug: ARB (including valsartan, telmisartan, olmesartan)

Procedure: Chronotherapy, timing of antihypertensive medication

Drug: diuretics (torasemide, indapamide, HTCZ) and doxazosin

Drug: ACEI (including spirapril, enalapril, quinapril, lisinopril)

Drug: beta blockers (including nebivolol, atenolol, carvedilol)

Device: Ambulatory blood pressure monitoring

2

Active Comparator group

Description:

Treatment at bedtime

Treatment:

Procedure: Combination therapy in essential hypertension

Drug: ARB (including valsartan, telmisartan, olmesartan)

Procedure: Chronotherapy, timing of antihypertensive medication

Drug: diuretics (torasemide, indapamide, HTCZ) and doxazosin

Drug: ACEI (including spirapril, enalapril, quinapril, lisinopril)

Drug: beta blockers (including nebivolol, atenolol, carvedilol)

Device: Ambulatory blood pressure monitoring