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HypertensionPhase 4MAPECNCT00295542

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

A Phase 4 study testing Ambulatory blood pressure monitoring, Chronotherapy, timing of antihypertensive medication and ACEI (including spirapril, enalapril, quinapril, lisinopril) in people with Hypertension, run by University of Vigo at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
Ambulatory blood pressure monitoring, Chronotherapy, timing of antihypertensive medication and ACEI (including spirapril, enalapril, quinapril, lisinopril)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,344 participants
Where
1 siteSpain
Study dates
Mar 2000to Apr 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Essential hypertension

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clinico Universitario

    Santiago de Compostela, 15706

Other trials in Spain

About this study

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).

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.

Read the 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.

Conditions
Hypertension
Being tested
Ambulatory blood pressure monitoring, Chronotherapy, timing of antihypertensive medication, ACEI (including spirapril, enalapril, quinapril, lisinopril), ARB (including valsartan, telmisartan, olmesartan), beta blockers (including nebivolol, atenolol, carvedilol)
Keywords
ambulatory blood pressure monitoring, cardiovascular risk, chronotherapy, circadian pattern
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ambulatory blood pressure monitoringDevice

    Sampling at 20-min intervals from 07:00 to 23:00 hours and at 30-min intervals at night for 48 consecutive hours

  • Chronotherapy, timing of antihypertensive medicationProcedure or surgery

    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 doxazosinDrug

    Treatment at awakening versus bedtime

  • Combination therapy in essential hypertensionProcedure or surgery

    Treatment at awakening versus bedtime

Study groups in NCT00295542
Study groupRoleWhat they receive
1Active comparatorTreatment on awakening
Receives: 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
2Active comparatorTreatment at bedtime
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Five years

Secondary outcomes (2)

  1. Influence of circadian time of antihypertensive treatment in BP control and the remodeling of the circadian BP pattern of hypertensive patients.

    Measured: Five years

  2. Prevalence of an altered BP profile as a function of the circadian time of treatment.

    Measured: Five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2006 (estimated)
  2. Study startMar 2000
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00295542
Sponsor's protocol ID
PGIDIT03-PXIB-32201PR
Other IDs
SAF2006-6254, INCITE07-PXI-322003ES
Acronym
MAPEC
Status last verified
Apr 2009
First submitted
21 Feb 2006
Last updated
28 Apr 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26399404

  • 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.

    PubMed 21884956

  • 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.

    PubMed 21617110

  • 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.

    PubMed 19407805

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ambulatory blood pressure monitoring, Chronotherapy, timing of antihypertensive medication and ACEI (including spirapril, enalapril, quinapril, lisinopril) in people with Hypertension, run by University of Vigo at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00295542, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2009.

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