A survey evaluating blood pressure control and treatment adherence in the general hypertensive population with concomitant hypercholesterolemia or stable coronary artery disease
| ISRCTN | ISRCTN54891603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54891603 |
| Protocol serial number | DIM-05153-001 |
| Sponsor | Servier International |
| Funder | Servier International |
- Submission date
- 12/07/2017
- Registration date
- 13/09/2017
- Last edited
- 15/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Hypertension (high blood pressure) and hypercholesterolemia (high blood cholesterol) are two of the most commonly co-occurring cardiovascular (heart disease) risk factors, with 338 million patients worldwide with both conditions. Reductions in blood pressure or total cholesterol have been shown to reduce the risk of cardiovascular disease. However, blood pressure control in these patients is difficult, with a major contributing factor being poor adherence to treatment, which has been shown to be significantly improved by the use of single-pill combinations. The aim of this study is to assess blood pressure control in hypertensive patients with hypercholesterolemia or stable coronary artery disease.
Who can participate?
Hypertensive outpatients aged over 18 with hypercholesterolemia or stable coronary artery disease
What does the study involve?
Participants’ medical history, other diseases and medications are assessed using a questionnaire. Treatment adherence is assessed by asking about their current use of antihypertensive medication and statins.
What are the possible benefits and risks of participating?
Participation in the study will enable a better understanding of how patients with high blood pressure are characterized, treated and managed. No additional investigations or treatments are required in order to collect the data, therefore there is no risk to the participants.
Where is the study run from?
University Hospital Leipzig (Germany)
When is the study starting and how long is it expected to run for?
March 2017 to August 2017
Who is funding the study?
Servier International (France)
Who is the main contact?
1. Ms Andrea Korzinek
2. Prof. Ulrich Laufs
Contact information
Public
Elsenheimerstr. 53
Munich
80687
Germany
Scientific
University Hospital Leipzig
Liebigstr. 20
Leipzig
04103
Germany
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-visit multicentric non-interventional cross-sectional survey |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | A survey evaluating blood pressure control and treatment adherence in the general hypertensive population with concomitant hypercholesterolemia or stable coronary artery disease: an observational cross-sectional study |
| Study objectives | The primary objective is to evaluate blood pressure control in hypertensive patients with concomitant hypercholesterolemia or stable coronary artery disease (stable CAD). The secondary objective is to evaluate treatment adherence using the Morisky Medication Adherence Scale-8 (MMAS-8) self-assessment questionnaire and number of antihypertensive pills prescribed. |
| Ethics approval(s) | Ethics Commission at the Medical Association of the Saarland (Germany), 25/01/2017, ref: ID: 307/16 |
| Health condition(s) or problem(s) studied | Hypertensive outpatients with concomitant hypercholesterolemia or stable coronary artery disease |
| Intervention | Medical history, concomitant diseases and medication will be documented by a questionnaire. Treatment adherence will be assessed by self-reported current use of antihypertensive medication and statins using the MMAS-8. |
| Intervention type | Other |
| Primary outcome measure(s) |
Blood pressure control, evaluated using office blood pressure values and blood pressure targets corresponding to the latest ESH/ESC Guidelines for the management of arterial hypertension 2013. One visit per patient (snapshot, no follow-up data) |
| Key secondary outcome measure(s) |
Treatment adherence and number of antihypertensive pills prescribed, evaluated using the Morisky Medication Adherence Scale-8 (MMAS-8) self-assessment questionnaire. One visit per patient (snapshot, no follow-up data) |
| Completion date | 01/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 3500 |
| Total final enrolment | 3188 |
| 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 medication 5. Prescription of a statin 6. Signed consent form |
| Key exclusion criteria | Patients hospitalized for cardiovascular diseases in the last 3 months (including revascularization) |
| Date of first enrolment | 15/03/2017 |
| Date of final enrolment | 31/08/2017 |
Locations
Countries of recruitment
- Germany
Study participating centre
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. The data required for the statistical evaluation of this survey will be transmitted in pseudonymised (encrypted) form to Servier Deutschland GmbH and to a data processing office commissioned by Servier Deutschland GmbH, called PHARMALOG Institut für klinische Forschung GmbH (Neumarkter Strasse 18, 81673 Munich) as well as in anonymized form to Servier International 35 rue de Verdun, 92285 Suresnes cedex, and they will be stored at these three locations for a maximum of 10 years. This will take place in accordance with the data protection regulations in force in Germany. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/12/2018 | 15/04/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/04/2019: Publication reference and total final enrolment added.
