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
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 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
Other
Phase
Drug names
Primary outcome measure
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 (if study stopped)
Eligibility
Participant inclusion criteria
All hypertensive patients treated with more than one antihypertensive drug consulting a general practitioner
Participant type
Patient
Age group
All
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
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 report will be written and data will be send out for publication.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30383839