Evaluation of achieved blood pressure control with more than one antihypertensive drug in patients treated by general practitioners in Belgium
| ISRCTN | ISRCTN14491942 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14491942 |
| Secondary identifying numbers | Visa Pharma.be: VI 14/10/06/01 |
- Submission date
- 13/04/2016
- Registration date
- 14/04/2016
- Last edited
- 19/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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)
Contact information
Public
Servier BeLux
Internationalelaan 57
Anderlecht
1070
Belgium
Scientific
Servier BeLux
Internationalelaan 57
Anderlecht
1070
Belgium
Study information
| Study design | Cross-sectional observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | ACHIEVE |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 16/10/2014 |
| Completion date | 14/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 10000 |
| Key inclusion criteria | All hypertensive patients treated with more than one antihypertensive drug consulting a general practitioner |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 19/01/2015 |
| Date of final enrolment | 14/02/2016 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Brussel
1070
Belgium
Sponsor information
Industry
Internationalelaan 57
Anderlecht
1070
Belgium
"ROR" |
https://ror.org/034e7c066 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2018 | Yes | No | |
| Dataset | 01/11/2018 | 19/05/2023 | No | No | |
| Protocol (other) | 01/11/2018 | 19/05/2023 | No | No |
Editorial Notes
19/05/2023: Protocol and datasets added.
04/12/2018: Publication reference added.
09/02/2017: Internal review.
