Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy (MAPEC)
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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). |
- 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 ]
- 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 |
Inclusion Criteria:
- Essential hypertension
Exclusion Criteria:
- AIDS
- shift workers
- secondary hypertension
- intolerant to ABPM
Contacts and Locations| Spain | |
| Hospital Clinico Universitario | |
| Santiago de Compostela, Spain, 15706 | |
| 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 Adrenergic beta-Antagonists Atenolol Carvedilol Nebivolol Quinapril Torsemide Valsartan Antihypertensive Agents Enalapril Indapamide Lisinopril Doxazosin |
Diuretics Spirapril Telmisartan Olmesartan Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Cardiovascular Agents Therapeutic Uses Anti-Arrhythmia Agents Sympatholytics Autonomic Agents |
ClinicalTrials.gov processed this record on June 18, 2013