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

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ClinicalTrials.gov Identifier: NCT00295542
Recruitment Status : Completed
First Posted : February 23, 2006
Last Update Posted : April 28, 2009
Sponsor:
Collaborators:
Hospital Clinico Universitario de Santiago
Xunta de Galicia
Ministerio de Educacion y Ciencia, Spain
Information provided by:
University of Vigo

Tracking Information
First Submitted Date  ICMJE February 21, 2006
First Posted Date  ICMJE February 23, 2006
Last Update Posted Date April 28, 2009
Study Start Date  ICMJE March 2000
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2006)
  • circadian pattern of blood pressure determined by ambulatory monitoring
  • cardiovascular and cerebrovascular events per year of follow-up
  • total cardiovascular mortality per year of follow-up
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2008)
  • 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 ]
  • Prevalence of an altered BP profile as a function of the circadian time of treatment. [ Time Frame: Five years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy
Official Title  ICMJE Prognostic Value of Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy in Relation to Risk (the MAPEC Study).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Treatment on awakening
    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
  • Active Comparator: 2
    Treatment at bedtime
    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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2009)
3344
Original Enrollment  ICMJE
 (submitted: February 22, 2006)
3000
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Essential hypertension

Exclusion Criteria:

  • AIDS
  • shift workers
  • secondary hypertension
  • intolerant to ABPM
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00295542
Other Study ID Numbers  ICMJE PGIDIT03-PXIB-32201PR
SAF2006-6254
INCITE07-PXI-322003ES
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ramon C. Hermida, University of Vigo
Study Sponsor  ICMJE University of Vigo
Collaborators  ICMJE
  • Hospital Clinico Universitario de Santiago
  • Xunta de Galicia
  • Ministerio de Educacion y Ciencia, Spain
Investigators  ICMJE
Principal Investigator: Ramon C Hermida, PhD University of Vigo
PRS Account University of Vigo
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP