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

NCT ID: NCT00295542

Last Updated: 2009-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2009-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Treatment on awakening

Group Type ACTIVE_COMPARATOR

Ambulatory blood pressure monitoring

Intervention Type 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

Intervention Type PROCEDURE

Comparison of effects of awakening versus bedtime dosing

ACEI (including spirapril, enalapril, quinapril, lisinopril)

Intervention Type DRUG

Treatment at awakening versus bedtime

ARB (including valsartan, telmisartan, olmesartan)

Intervention Type DRUG

Treatment at awakening versus bedtime

beta blockers (including nebivolol, atenolol, carvedilol)

Intervention Type DRUG

Treatment at awakening versus bedtime

diuretics (torasemide, indapamide, HTCZ) and doxazosin

Intervention Type DRUG

Treatment at awakening versus bedtime

Combination therapy in essential hypertension

Intervention Type PROCEDURE

Treatment at awakening versus bedtime

2

Treatment at bedtime

Group Type ACTIVE_COMPARATOR

Ambulatory blood pressure monitoring

Intervention Type 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

Intervention Type PROCEDURE

Comparison of effects of awakening versus bedtime dosing

ACEI (including spirapril, enalapril, quinapril, lisinopril)

Intervention Type DRUG

Treatment at awakening versus bedtime

ARB (including valsartan, telmisartan, olmesartan)

Intervention Type DRUG

Treatment at awakening versus bedtime

beta blockers (including nebivolol, atenolol, carvedilol)

Intervention Type DRUG

Treatment at awakening versus bedtime

diuretics (torasemide, indapamide, HTCZ) and doxazosin

Intervention Type DRUG

Treatment at awakening versus bedtime

Combination therapy in essential hypertension

Intervention Type PROCEDURE

Treatment at awakening versus bedtime

Interventions

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Ambulatory blood pressure monitoring

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

Intervention Type DEVICE

Chronotherapy, timing of antihypertensive medication

Comparison of effects of awakening versus bedtime dosing

Intervention Type PROCEDURE

ACEI (including spirapril, enalapril, quinapril, lisinopril)

Treatment at awakening versus bedtime

Intervention Type DRUG

ARB (including valsartan, telmisartan, olmesartan)

Treatment at awakening versus bedtime

Intervention Type DRUG

beta blockers (including nebivolol, atenolol, carvedilol)

Treatment at awakening versus bedtime

Intervention Type DRUG

diuretics (torasemide, indapamide, HTCZ) and doxazosin

Treatment at awakening versus bedtime

Intervention Type DRUG

Combination therapy in essential hypertension

Treatment at awakening versus bedtime

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Essential hypertension

Exclusion Criteria

* AIDS
* shift workers
* secondary hypertension
* intolerant to ABPM
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role collaborator

Ministry of Work and Welfare - Xunta de Galicia

OTHER_GOV

Sponsor Role collaborator

Ministerio de Educacion y Ciencia, Spain

UNKNOWN

Sponsor Role collaborator

University of Vigo

OTHER

Sponsor Role lead

Responsible Party

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University of Vigo

Principal Investigators

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Ramon C Hermida, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vigo

Locations

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Hospital Clinico Universitario

Santiago de Compostela, , Spain

Site Status

Countries

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Spain

References

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Hermida RC, Ayala DE, Mojon A, Fernandez JR. Bedtime ingestion of hypertension medications reduces the risk of new-onset type 2 diabetes: a randomised controlled trial. Diabetologia. 2016 Feb;59(2):255-65. doi: 10.1007/s00125-015-3749-7. Epub 2015 Sep 23.

Reference Type DERIVED
PMID: 26399404 (View on PubMed)

Hermida RC, Ayala DE, Mojon A, Fernandez JR. Decreasing sleep-time blood pressure determined by ambulatory monitoring reduces cardiovascular risk. J Am Coll Cardiol. 2011 Sep 6;58(11):1165-73. doi: 10.1016/j.jacc.2011.04.043.

Reference Type DERIVED
PMID: 21884956 (View on PubMed)

Hermida RC, Ayala DE, Mojon A, Fernandez JR. Influence of time of day of blood pressure-lowering treatment on cardiovascular risk in hypertensive patients with type 2 diabetes. Diabetes Care. 2011 Jun;34(6):1270-6. doi: 10.2337/dc11-0297.

Reference Type DERIVED
PMID: 21617110 (View on PubMed)

Hermida RC, Ayala DE, Mojon A, Fernandez JR. Ambulatory blood pressure control with bedtime aspirin administration in subjects with prehypertension. Am J Hypertens. 2009 Aug;22(8):896-903. doi: 10.1038/ajh.2009.83. Epub 2009 Apr 30.

Reference Type DERIVED
PMID: 19407805 (View on PubMed)

Other Identifiers

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SAF2006-6254

Identifier Type: -

Identifier Source: secondary_id

INCITE07-PXI-322003ES

Identifier Type: -

Identifier Source: secondary_id

PGIDIT03-PXIB-32201PR

Identifier Type: -

Identifier Source: org_study_id

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