Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy
Information source: University of Vigo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Ambulatory blood pressure monitoring (Device); Chronotherapy, timing of antihypertensive medication (Procedure); 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 (Drug); Combination therapy in essential hypertension (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: University of Vigo Official(s) and/or principal investigator(s): Ramon C Hermida, PhD, Principal Investigator, Affiliation: University of Vigo
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.
Clinical Details
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).
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Influence of circadian time of antihypertensive treatment in BP control and the remodeling of the circadian BP pattern of hypertensive patients.Prevalence of an altered BP profile as a function of the circadian time of treatment.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Essential hypertension
Exclusion Criteria:
- AIDS
- shift workers
- secondary hypertension
- intolerant to ABPM
Locations and Contacts
Hospital Clinico Universitario, Santiago de Compostela 15706, Spain
Additional Information
Starting date: March 2000
Last updated: April 27, 2009
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