Viewing Study NCT00295542



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Study NCT ID: NCT00295542
Status: COMPLETED
Last Update Posted: 2009-04-28
First Post: 2006-02-21

Brief Title: Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy
Sponsor: University of Vigo
Organization: University of Vigo

Study Overview

Official 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
Status: COMPLETED
Status Verified Date: 2009-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MAPEC
Brief Summary: The MAPEC study was designed to investigate whether normalizing the circadian blood pressure profile towards a more dipper pattern increasing the diurnalnocturnal 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 diurnalnocturnal 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
INCITE07-PXI-322003ES None None None
SAF2006-6254 None None None