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Completed

NCT Number: NCT00295542

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinico Universitario

Santiago de Compostela, 15706, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Essential hypertension

Exclusion criteria

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

Treatment and study plan

Ambulatory blood pressure monitoring

Device

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

Chronotherapy, timing of antihypertensive medication

Procedure

Comparison of effects of awakening versus bedtime dosing

ACEI (including spirapril, enalapril, quinapril, lisinopril)

Drug

Treatment at awakening versus bedtime

ARB (including valsartan, telmisartan, olmesartan)

Drug

Treatment at awakening versus bedtime

beta blockers (including nebivolol, atenolol, carvedilol)

Drug

Treatment at awakening versus bedtime

diuretics (torasemide, indapamide, HTCZ) and doxazosin

Drug

Treatment at awakening versus bedtime

Combination therapy in essential hypertension

Procedure

Treatment at awakening versus bedtime

Primary outcomes

  1. 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.

    Time frame: Five years

Secondary outcomes

  1. Influence of circadian time of antihypertensive treatment in BP control and the remodeling of the circadian BP pattern of hypertensive patients.

    Time frame: Five years

  2. Prevalence of an altered BP profile as a function of the circadian time of treatment.

    Time frame: Five years

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Collaborators

  • Hospital Clinico Universitario de Santiago
  • Ministerio de Educacion y Ciencia, Spain
  • Ministry of Work and Welfare - Xunta de Galicia

Registry information

Official study 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).

Acronym: MAPEC

Important dates

Study start
2000
Primary completion
2009
Study completion
2009
First posted
Feb 23, 2006
Registry last updated
Apr 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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