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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00295542
Acronym
MAPEC
Enrollment
3344
Registered
2006-02-23
Start date
2000-03-31
Completion date
2009-04-30
Last updated
2009-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

ambulatory blood pressure monitoring, cardiovascular risk, chronotherapy, circadian pattern

Brief 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.

Interventions

PROCEDURECombination therapy in essential hypertension

Treatment at awakening versus bedtime

Sampling at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours

PROCEDUREChronotherapy, timing of antihypertensive medication

Comparison of effects of awakening versus bedtime dosing

DRUGACEI (including spirapril, enalapril, quinapril, lisinopril)

Treatment at awakening versus bedtime

DRUGARB (including valsartan, telmisartan, olmesartan)

Treatment at awakening versus bedtime

DRUGbeta blockers (including nebivolol, atenolol, carvedilol)

Treatment at awakening versus bedtime

DRUGdiuretics (torasemide, indapamide, HTCZ) and doxazosin

Treatment at awakening versus bedtime

Sponsors

Hospital Clinico Universitario de Santiago
CollaboratorOTHER
Ministry of Work and Welfare - Xunta de Galicia
CollaboratorOTHER_GOV
Ministerio de Educacion y Ciencia, Spain
CollaboratorUNKNOWN
University of Vigo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Essential hypertension

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Prognostic value of ABPM, impact of changes in ambulatory BP and impact of circadian time of antihypertensive treatment in cardiovascular, cerebrovascular and renal risk assessment.Five years

Secondary

MeasureTime frame
Influence of circadian time of antihypertensive treatment in BP control and the remodeling of the circadian BP pattern of hypertensive patients.Five years
Prevalence of an altered BP profile as a function of the circadian time of treatment.Five years

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026