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| ID | Type | Description | Link |
|---|---|---|---|
| SAF2006-6254 | |||
| INCITE07-PXI-322003ES |
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| Name | Class |
|---|---|
| Hospital Clinico Universitario de Santiago | OTHER |
| Ministry of Work and Welfare - Xunta de Galicia | OTHER_GOV |
| Ministerio de Educacion y Ciencia, Spain | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Treatment on awakening |
|
| 2 | Active Comparator | Treatment at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory blood pressure monitoring | Device | Sampling at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Five years |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of circadian time of antihypertensive treatment in BP control and the remodeling of the circadian BP pattern of hypertensive patients. | Five years | |
| Prevalence of an altered BP profile as a function of the circadian time of treatment. | Five years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramon C Hermida, PhD | University of Vigo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universitario | Santiago de Compostela | 15706 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26399404 | Derived | 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. | |
| 21884956 | Derived | 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. |
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| Chronotherapy, timing of antihypertensive medication | Procedure | Comparison of effects of awakening versus bedtime dosing |
|
| ACEI (including spirapril, enalapril, quinapril, lisinopril) | Drug | Treatment at awakening versus bedtime |
|
| ARB (including valsartan, telmisartan, olmesartan) | Drug | Treatment at awakening versus bedtime |
|
| beta blockers (including nebivolol, atenolol, carvedilol) | Drug | Treatment at awakening versus bedtime |
|
| diuretics (torasemide, indapamide, HTCZ) and doxazosin | Drug | Treatment at awakening versus bedtime |
|
| Combination therapy in essential hypertension | Procedure | Treatment at awakening versus bedtime |
|
| 21617110 | Derived | 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. |
| 19407805 | Derived | 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. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D018660 | Blood Pressure Monitoring, Ambulatory |
| D019454 | Chronotherapy |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D004656 | Enalapril |
| D000077583 | Quinapril |
| D017706 | Lisinopril |
| D000077333 | Telmisartan |
| C437965 | olmesartan |
| D000319 | Adrenergic beta-Antagonists |
| D001262 | Atenolol |
| D000077261 | Carvedilol |
| D004232 | Diuretics |
| D000077786 | Torsemide |
| D007190 | Indapamide |
| D017292 | Doxazosin |
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
| D013812 | Therapeutics |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045505 | Physiological Effects of Drugs |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D045283 | Natriuretic Agents |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011224 | Prazosin |
| D011799 | Quinazolines |
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