Evaluation of the control of risk factors to develop ATHEROsclerosis in patients treated by general practioners in Belgium and Luxembourg
| ISRCTN | ISRCTN12117571 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12117571 |
| Secondary identifying numbers | ATHERO IC4-05153-024-BEL |
- Submission date
- 05/01/2018
- Registration date
- 16/01/2018
- Last edited
- 06/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Hypertension and hypercholesterolemia are two of the most commonly co-occurring cardiovascular risk factors. Hypertension is the leading cardiovascular risk factor contributing to global mortality and nearly half of the hypertensive patients are also diagnosed with hypercholesterolemia. Co-existence of hypertension and hypercholesterolemia has more than an additive adverse impact on the vascular endothelium, resulting in increased atherosclerosis and a subsequent increase in coronary events. Unfortunately, concomitant hypertension and hypercholesterolemia are very difficult to control. This is in part due to poor adherence to medication in individuals at high cardiovascular risk and in patients with coronary artery disease, resulting in worse outcomes and higher healthcare costs. Evidence shows that single-pill combination therapy decreases the risk of medication non-adherence compared with free combination therapy and improved adherence in turn has been shown to significantly improve CV outcomes. In Belgium, there are few epidemiological data on current treatment of hypertensive patients with concomitant hypercholesterolemia or stable coronary artery disease and the way in which general practitioners apply the treatment recommendations in current clinical practice. With this study we try to bridge this gap of knowledge by evaluating in daily clinical practice at the general practitioner level the control of risk factors to develop atherosclerosis in patients treated with at least one antihypertensive agent and a statin.
Who can participate?
Adults treated with at least one antihypertensive agent and one statin and seen by a general practitioner in Belgium.
What does the study involve?
General practitioners records information of patient on a routine consultation about their background, current medical treatment, blood pressure and LDL-c levels.
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?
Servier BeNeLux (Belgium)
When is the study starting and how long is it expected to run for?
November 2017 to January 2019
Who is funding the study?
Servier BeNeLux (Belgium)
Who is the main contact?
Mr. Bregt Van Nieuwenhuyse
Contact information
Scientific
Servier Benelux
Internationalelaan 57
Anderlecht
1070
Belgium
| Phone | +32 252 94311 |
|---|---|
| bregt.vannieuwenhuyse@servier.com |
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 study evaluating the control of risk factors to develop ATHEROsclerosis in the general population of Belgium and Luxembourg treated with at least one antihypertensive agent and a statin. |
| Study acronym | ATHERO |
| Study objectives | The aim of this study is to evaluate in daily clinical practice at the general practitioner level in Belgium and Luxembourg the control of risk factors that develop atherosclerosis in patients treated with at least one antihypertensive agent and a statin. |
| 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. |
| Health condition(s) or problem(s) studied | Hypertension |
| Intervention | All participants attend an appointment to see their general practitioner, who is asked to record the following information: 1. Number of the patient in the study (1 to 15) 2. Age, sex, weight and height of the patient 3. Presence of concomitant cardiovascular risk factors/co-morbidities (diabetes, prior CV events, renal disease, heart failure, peripheral vascular disease, smoking, at risk age, familial predisposition) 4. Systolic/diastolic blood pressure (mmHg) 5. LDL-c and total cholesterol values (mg/dl) (measured within previous 12 months) 6. Physician-reported attainment of LDL target and BP control according to international guidelines 7. Antihypertensive treatment before consultation (name, therapeutic class and daily dose) 8. Cholesterol lowering treatment before consultation (name, therapeutic class and daily dose) 9. Motivation to use single pill combinations before treatment of hypertension and dyslipidemia Due to the transversal nature of the study, no follow-up of the patients is performed. |
| Intervention type | Other |
| Primary outcome measure | 1. Systolic and diastolic blood pressure values is measured using according to the general practitioners’ standard operating procedure during consultation 2. LDL-c and total cholesterol is noted based on medical records at time of consultation |
| Secondary outcome measures | 1. Number of antihypertensive and cholesterol lowering drugs taken before consultation is measured using medical records 2. Cardiovascular risk of on-treatment patients in Belgium and Luxembourg is measured using medical records and patient anamnesis during consultation 3. Judged BP control and cholesterol control is measured by asking the general practitioners’ clinical evaluation during consultation 4. Judgement of the suitability of the patient for single pill combinations & motivation is measured using by asking the general practitioners’ clinical evaluation during consultation 5. Types of antihypertensive and lipid lowering treatment used in Belgium and Luxembourg is measured using medical records |
| Overall study start date | 15/11/2017 |
| Completion date | 31/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 4725 |
| Total final enrolment | 2337 |
| Key inclusion criteria | 1. Age ≥ 18 years 2. Confirmed (in medical records) diagnosis of hypertension 3. Confirmed (in medical records) diagnosis of hypercholesterolemia or stable coronary artery disease 4. Prescription of ≥ 1 antihypertensive drug 5. Prescription of a statin |
| Key exclusion criteria | Patients hospitalised for cardiovascular diseases in the last 3 months (including revascularization). |
| Date of first enrolment | 01/02/2018 |
| Date of final enrolment | 19/01/2019 |
Locations
Countries of recruitment
- Belgium
- Luxembourg
Study participating centre
Anderlecht
1070
Belgium
Sponsor information
Industry
Internationalelaan 57
Anderlecht
1070
Belgium
| Phone | +32 252 94311 |
|---|---|
| bregt.vannieuwenhuyse@servier.com | |
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | After completion of the study a scientific report will be written and data will be send out for publication. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from bregt.vannieuwenuyse@servier.com. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 06/10/2022 | No | No |
Additional files
Editorial Notes
06/10/2022: Uploaded protocol (not peer reviewed).
20/07/2021: The intention to publish date was changed from 01/07/2021 to 01/09/2021.
09/03/2021: The intention to publish date was changed from 01/09/2020 to 01/07/2021.
24/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 19/10/2018 to 19/01/2019.
2. The final enrolment number has been added.
29/11/2018: The following changes were made:
1. The overall trial end date was changed from 19/01/2019 to 31/01/2019.
2. The intention to publish date was changed from 01/01/2020 to 01/09/2020.
