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

NCT00295542 | Completed Phase 4 DMC

• 3 other identifiers: PGIDIT03-PXIB-32201PRSAF2006-6254INCITE07-PXI-322003ES
• Study Type: interventional
• Target: 3,344
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

ambulatory blood pressure monitoring; cardiovascular risk; chronotherapy; circadian pattern

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Treatment on awakening

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

2

ACTIVE COMPARATOR

Treatment at bedtime

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

Interventions

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

1; 2

Chronotherapy, timing of antihypertensive medication PROCEDURE

Comparison of effects of awakening versus bedtime dosing

1; 2

ACEI (including spirapril, enalapril, quinapril, lisinopril) DRUG

Treatment at awakening versus bedtime

1; 2

ARB (including valsartan, telmisartan, olmesartan) DRUG

Treatment at awakening versus bedtime

1; 2

beta blockers (including nebivolol, atenolol, carvedilol) DRUG

Treatment at awakening versus bedtime

1; 2

diuretics (torasemide, indapamide, HTCZ) and doxazosin DRUG

Treatment at awakening versus bedtime

1; 2

Combination therapy in essential hypertension PROCEDURE

Treatment at awakening versus bedtime

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Essential hypertension

You may not qualify if:

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

Sponsors & Collaborators

• University of Vigo: lead
• Hospital Clinico Universitario de Santiago: collaborator
• Ministry of Work and Welfare - Xunta de Galicia: collaborator
• Ministerio de Educacion y Ciencia, Spain: collaborator

Study Sites (1)

Hospital Clinico Universitario

Santiago de Compostela, 15706, Spain

Location

Related Publications (4)

• 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.

  PMID: 26399404 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.

  PMID: 21884956 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.

  PMID: 21617110 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.

  PMID: 19407805 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure Monitoring, Ambulatory; Chronotherapy; Angiotensin-Converting Enzyme Inhibitors; Enalapril; Quinapril; Lisinopril; Telmisartan; olmesartan; Adrenergic beta-Antagonists; Atenolol; Carvedilol; Diuretics; Torsemide; Indapamide; Doxazosin; Combined Modality Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic; Therapeutics; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Natriuretic Agents; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Prazosin; Quinazolines

Study Officials

• Ramon C Hermida, PhD

  University of Vigo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: February 23, 2006
• Study Start: March 1, 2000
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 28, 2009

Record last verified: 2009-04

Locations

ES (1)