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
Secondary identifying numbers DIM-05153-001
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Ms Andrea Korzinek
Public

Elsenheimerstr. 53
Munich
80687
Germany

Prof Ulrich Laufs
Scientific

University Hospital Leipzig
Liebigstr. 20
Leipzig
04103
Germany

Study information

Study designSingle-visit multicentric non-interventional cross-sectional survey
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)GP practice
Study typeScreening
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA 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 objectivesThe 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) studiedHypertensive outpatients with concomitant hypercholesterolemia or stable coronary artery disease
InterventionMedical 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 typeOther
Primary outcome measureBlood 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 measuresTreatment 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 study start date01/09/2016
Completion date01/12/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants3500
Total final enrolment3188
Key inclusion criteria1. 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 criteriaPatients hospitalized for cardiovascular diseases in the last 3 months (including revascularization)
Date of first enrolment15/03/2017
Date of final enrolment31/08/2017

Locations

Countries of recruitment

  • Germany

Study participating centre

University Hospital Leipzig
04103
Germany

Sponsor information

Servier International
Industry

35 rue de Verdun
Suresnes
92285
France

ROR logo "ROR" https://ror.org/034e7c066

Funders

Funder type

Industry

Servier International

No information available

Results and Publications

Intention to publish date01/12/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe 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

Editorial Notes

15/04/2019: Publication reference and total final enrolment added.