Clinical trial NCT00295542: Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: ambulatory blood pressure monitoring
cardiovascular risk
chronotherapy
circadian pattern
Lead sponsor: University of Vigo
Sponsor class: OTHER
Collaborators: name: Hospital Clinico Universitario de Santiago
name: Ministry of Work and Welfare - Xunta de Galicia
name: Ministerio de Educacion y Ciencia, Spain
First posted: 2006-02-23
Enrollment: 3344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Essential hypertension

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: Five years
Secondary outcomes:
measure: Influence of circadian time of antihypertensive treatment in BP control and the remodeling of the circadian BP pattern of hypertensive patients.
timeFrame: Five years
measure: Prevalence of an altered BP profile as a function of the circadian time of treatment.
timeFrame: Five years
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario
Study officials:
affiliation: University of Vigo
name: Ramon C Hermida, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.