Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DIM-05153-001
Study information
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
Acronym
Study hypothesis
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
Ethics Commission at the Medical Association of the Saarland (Germany), 25/01/2017, ref: ID: 307/16
Study design
Single-visit multicentric non-interventional cross-sectional survey
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
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)
Secondary outcome measures
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)
Overall trial start date
01/09/2016
Overall trial end date
01/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3500
Total final enrolment
3188
Participant exclusion criteria
Patients hospitalized for cardiovascular diseases in the last 3 months (including revascularization)
Recruitment start date
15/03/2017
Recruitment end date
31/08/2017
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital Leipzig
04103
Germany
Funders
Funder type
Industry
Funder name
Servier International
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
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.
Intention to publish date
01/12/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30587940 (added 15/04/2019)