Condition category
Circulatory System
Date applied
12/07/2017
Date assigned
13/09/2017
Last edited
13/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Ms Andrea Korzinek

ORCID ID

Contact details

Elsenheimerstr. 53
Munich
80687
Germany

Type

Scientific

Additional contact

Prof Ulrich Laufs

ORCID ID

Contact details

University Hospital Leipzig
Liebigstr. 20
Leipzig
04103
Germany

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 measures

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

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

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

Sponsor information

Organisation

Servier International

Sponsor details

35 rue de Verdun
Suresnes
92285
France

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes