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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Device: Ambulatory blood pressure monitoring; Procedure: Chronotherapy, timing of antihypertensive medication; Drug: 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; Procedure: Combination therapy in essential hypertension

• Registration Number: NCT00295542
• Lead Sponsor: University of Vigo

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.

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2006-02-21
• Study First Submitted QC: 2006-02-22
• Study First Posted: 2006-02-23
• Status Verified: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-04-27
• Last Update Posted: 2009-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3344

Inclusion Criteria

• Essential hypertension

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ambulatory blood pressure monitoring	Treatment on awakening
1	Chronotherapy, timing of antihypertensive medication	Treatment on awakening
1	ACEI (including spirapril, enalapril, quinapril, lisinopril)	Treatment on awakening
1	ARB (including valsartan, telmisartan, olmesartan)	Treatment on awakening
1	beta blockers (including nebivolol, atenolol, carvedilol)	Treatment on awakening
1	diuretics (torasemide, indapamide, HTCZ) and doxazosin	Treatment on awakening
1	Combination therapy in essential hypertension	Treatment on awakening
2	Ambulatory blood pressure monitoring	Treatment at bedtime
2	Chronotherapy, timing of antihypertensive medication	Treatment at bedtime
2	ACEI (including spirapril, enalapril, quinapril, lisinopril)	Treatment at bedtime
2	ARB (including valsartan, telmisartan, olmesartan)	Treatment at bedtime
2	beta blockers (including nebivolol, atenolol, carvedilol)	Treatment at bedtime
2	diuretics (torasemide, indapamide, HTCZ) and doxazosin	Treatment at bedtime
2	Combination therapy in essential hypertension	Treatment at bedtime

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Clinico Universitario; 🇪🇸 Santiago de Compostela, Spain