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

This study has been completed.
Sponsor:
Collaborators:
Hospital Clinico Universitario de Santiago
Xunta de Galicia
Ministerio de Educacion y Ciencia, Spain
Information provided by:
University of Vigo
ClinicalTrials.gov Identifier:
NCT00295542
First received: February 21, 2006
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Hypertension
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by University of Vigo:

Primary Outcome Measures:
  • 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. [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Influence of circadian time of antihypertensive treatment in BP control and the remodeling of the circadian BP pattern of hypertensive patients. [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
  • Prevalence of an altered BP profile as a function of the circadian time of treatment. [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Enrollment: 3344
Study Start Date: March 2000
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Treatment on awakening
Device: 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
Procedure: Chronotherapy, timing of antihypertensive medication
Comparison of effects of awakening versus bedtime dosing
Drug: ACEI (including spirapril, enalapril, quinapril, lisinopril)
Treatment at awakening versus bedtime
Drug: ARB (including valsartan, telmisartan, olmesartan)
Treatment at awakening versus bedtime
Drug: beta blockers (including nebivolol, atenolol, carvedilol)
Treatment at awakening versus bedtime
Drug: diuretics (torasemide, indapamide, HTCZ) and doxazosin
Treatment at awakening versus bedtime
Procedure: Combination therapy in essential hypertension
Treatment at awakening versus bedtime
Active Comparator: 2
Treatment at bedtime
Device: 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
Procedure: Chronotherapy, timing of antihypertensive medication
Comparison of effects of awakening versus bedtime dosing
Drug: ACEI (including spirapril, enalapril, quinapril, lisinopril)
Treatment at awakening versus bedtime
Drug: ARB (including valsartan, telmisartan, olmesartan)
Treatment at awakening versus bedtime
Drug: beta blockers (including nebivolol, atenolol, carvedilol)
Treatment at awakening versus bedtime
Drug: diuretics (torasemide, indapamide, HTCZ) and doxazosin
Treatment at awakening versus bedtime
Procedure: Combination therapy in essential hypertension
Treatment at awakening versus bedtime

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Essential hypertension

Exclusion Criteria:

  • AIDS
  • shift workers
  • secondary hypertension
  • intolerant to ABPM
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295542

Locations
Spain
Hospital Clinico Universitario
Santiago de Compostela, Spain, 15706
Sponsors and Collaborators
University of Vigo
Hospital Clinico Universitario de Santiago
Xunta de Galicia
Ministerio de Educacion y Ciencia, Spain
Investigators
Principal Investigator: Ramon C Hermida, PhD University of Vigo
  More Information

No publications provided by University of Vigo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ramon C. Hermida, University of Vigo
ClinicalTrials.gov Identifier: NCT00295542     History of Changes
Other Study ID Numbers: PGIDIT03-PXIB-32201PR, SAF2006-6254, INCITE07-PXI-322003ES
Study First Received: February 21, 2006
Last Updated: April 27, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by University of Vigo:
ambulatory blood pressure monitoring
cardiovascular risk
chronotherapy
circadian pattern

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Adrenergic beta-Antagonists
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014