Condition category
Circulatory System
Date applied
13/04/2016
Date assigned
14/04/2016
Last edited
13/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hypertension is a long-term medical condition in which the pressure of blood travelling through the arteries is too high. This puts increased strain on the heart which, if left untreated, can lead to increased risk of heart attack or stroke. It is extremely common and is a major cause of death and disease worldwide, however many cases remain undiagnosed and treatment is not as effective as it could be. General practitioners play an important role in the early diagnosis and treatment of high blood pressure. In general, patients are treated with a combination of different drugs, as using a single drug is only effective in a limited number of patients. If initial treatment with two drugs fails then the current guidelines recommend increasing the dosage of these drugs, switching to two different drugs or adding a third drug. If treatment with three drugs is needed, the guidelines favour the use of fixed-dose or single-pill combinations, because reducing multiple drug treatment to one tablet daily helps improve the chance of patients always remembering to take their medication. The aim of this study is to complete a large-scale survey to investigate how well blood pressure is controlled in hypertensive patients who are being treated with more than one blood pressure medication.

Who can participate?
All hypertensive patients who are taking more than one blood pressure medication and are seen by the general practitioner cabinet in Belgium.

What does the study involve?
Participants attend appointments with their GP, who records their age and gender, current medical treatment, and blood pressure. The information is then collated in order to evaluate the blood pressure control of the participants.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved to those taking part in the study.

Where is the study run from?
Erasme Hospital Free University of Brussels (Belgium)

When is the study starting and how long is it expected to run for?
October 2014 to September 2016

Who is funding the study?
Servier BeLux (Belgium)

Who is the main contact?
1. Ms Valerie Pauwels (public)
2. Mr Bregt Van Nieuwenhuyse (scientific)

Trial website

Contact information

Type

Public

Primary contact

Ms Valerie Pauwels

ORCID ID

Contact details

Servier BeLux
Internationalelaan 57
Anderlecht
1070
Belgium

Type

Scientific

Additional contact

Mr Bregt Van Nieuwenhuyse

ORCID ID

Contact details

Servier BeLux
Internationalelaan 57
Anderlecht
1070
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Visa Pharma.be: VI 14/10/06/01

Study information

Scientific title

Cross-sectional survey evaluating blood pressure target ACHIEVEment in the Belgian general hypertensive population treated with multiple anti-hypertensive agents according to the treatment received

Acronym

ACHIEVE

Study hypothesis

The aim of this study is to evaluate the blood pressure control of hypertensive patients treated with multiple anti-hypertensive drugs according to the type of treatment received (number of drugs & free, fixed or mixed type of association).

Ethics approval

Due to the observational nature of this study, it does not require ethics approval according to the European directive and Belgian law. Nonetheless, the study has been approved by pharma.be (Bureau Des Visas Études Scientifiques Décision) on 16/10/2014 (dossier 14/10/06/01)

Study design

Cross-sectional observational study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hypertension

Intervention

Participants attend an appointment to see their general practitioner, who is asked to record the following information:
1. Age and sex of the patient
2. Presence of comorbidities (specify: diabetes, prior CV complications, renal insufficiency, or other)
3. Systolic and diastolic blood pressure
4. Is the patient controlled: Yes or No
5. Current antihypertensive treatment (free associations and/or fixed associations)
6. If the patients is not treated with a fixed association, would you switch them on: fixed bitherapy: Yes or No? // fixe tritherapy: Yes or No?
6.1. If Yes, for which reason?: better compliance?/Better blood pressure control?/better prognosis?/other?

Intervention type

Not Specified

Phase

Drug names

Primary outcome measures

Systolic and diastolic blood pressure is measured according to clinical practice during cabinet visit.

Secondary outcome measures

1. Isolated systolic hypertension is calculated based on blood pressure measurement according to clinical practice during cabinet visit.
2. Judged blood pressure control is written down in CRF by treating general practitioner during cabinet visit
3. Blood pressure control according to ESH/ESC guidelines is evaluated in comparison with blood pressure measurement according to clinical practice during cabinet visit.
4. Number of antihypertensive drugs is written down in CRF by treating general practitioner during cabinet visit
5. Type of antihypertensive associations used (free, fixed or mixed) is written down in CRF by treating general practitioner during cabinet visit

Overall trial start date

16/10/2014

Overall trial end date

14/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

All hypertensive patients treated with more than one antihypertensive drug consulting a general practitioner.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

10000

Participant exclusion criteria

No exclusion criteria

Recruitment start date

19/01/2015

Recruitment end date

14/02/2016

Locations

Countries of recruitment

Belgium

Trial participating centre

Erasme Hospital Free University of Brussels (Hôpital Erasme Université Libre de Bruxelles)
Route de Lennik 808
Brussel
1070
Belgium

Sponsor information

Organisation

Servier BeLux

Sponsor details

Internationalelaan 57
Anderlecht
1070
Belgium

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Servier BeLux

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The preliminary results will be sent out as an abstract. After completion of the study a scientific rapport will be written and data will be send out for publication.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes