Evaluation of the control of risk factors to develop ATHEROsclerosis in patients treated by general practioners in Belgium and Luxembourg

• Register: ISRCTN
• Last refreshed on: 17 October 2022
• Main ID: ISRCTN12117571
• Date of registration: 16/01/2018
• Prospective Registration: Yes
• Primary sponsor: Servier Benelux
• Public title: Evaluation of the control of risk factors to develop ATHEROsclerosis in patients treated by general practioners in Belgium and Luxembourg
• 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.
• Date of first enrolment: 01/02/2018
• Target sample size: 4725
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN12117571
• Study type: Observational
• Study design: Cross-sectional observational study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Belgium, Luxembourg

Contacts

• Name: Bregt Van Nieuwenhuyse

Key inclusion & exclusion criteria

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

Exclusion criteria: Patients hospitalised for cardiovascular diseases in the last 3 months (including revascularization).

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension
Circulatory System
Hypertension

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

ATHERO IC4-05153-024-BEL

Source(s) of Monetary Support

Servier Benelux

Ethics review

Status:
Approval date:
Contact:

Due to the observational nature of this study, it does not require ethics approval according to the European directive and Belgian law.

Results

• Results available: Yes
• Date Completed: 31/01/2019