Condition category
Circulatory System
Date applied
21/07/2016
Date assigned
08/09/2016
Last edited
19/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hypertension (high blood pressure) is a long term medical condition in which the pressure in the arteries is higher than it should be. This puts increased strain on the heart which, if left untreated, can lead to increased risk of heart attack or stroke. Antihypertensive treatments, such as medications to reduce blood pressure, are effective at lowering blood pressure and therefore stroke risk. This study aims to look at the blood pressure of middle-aged and older patients with high blood pressure and to see if there is a link with stroke risk and whether they are taking blood-pressure controlling medication.

Who can participate?
Adults aged 50 and over (60 and over in Columbia) who have high blood pressure.

What does the study involve?
Participants are reviewed as part of their usual clinical care, and once selected to participate in the study, are asked to sign an informed consent form. They then attend a single clinic visit at which their medical history, personal information, information about any medication they are taking to lower blood pressure and their blood pressure is taken. This information is then used to calculate the 5-year and 10-year risk of stroke for each patient using the Stroke Riskometer™ application.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
The study is run from Serdia Pharmaceuticals Pvt. Ltd. (India) and takes place in 176 health centres in India, 10 in Malaysia and 32 in Columbia.

When is the study starting and how long is it expected to run for?
October 2015 to December 2016

Who is funding the study?
Servier International (France)

Who is the main contact?
Dr Harpreet Lhoste

Trial website

Contact information

Type

Public

Primary contact

Dr Harpreet Lhoste

ORCID ID

Contact details

Servier International
50 rue Carnot
Suresnes
Ile de France
92284
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DIM-05520-001

Study information

Scientific title

SYSTUP: Study evaluating uncontrolled SYSTolic blood pressUre in middle-aged and older Patients with hypertension, in relation to stroke risk and current antihypertensive treatment

Acronym

SYSTUP

Study hypothesis

The aim of this study is to assess the level of raised systolic blood pressure in an older population, and to correlate this with stroke risk and antihypertensive treatment.

Ethics approval

1. India: Lancelot Independent Ethics Committee, 23/12/2015
2. Malaysia: pending
3. Colombia: pending

Study design

Multi-centre multi-country cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Hypertension (particularly a raised systolic blood pressure) and stroke risk

Intervention

If a potential participant fulfills the inclusion criteria, the investigator will present the main objectives of this study to them and will provide them with an information sheet. If the patient agrees to the recording of completely anonymous medical data concerning themselves, they will sign the participant consent form and be included into the study. Participants attend a single study visit at which the following data will be recorded using the case report form:
1. Demographic data (age)
2. Blood pressure reading during the visit with confirmation that systolic blood pressure is raised (blood pressure should be measured via the ESH guidelines using an auscultatory or oscillometric semiautomatic sphygmomanometer; allow the patient to sit for 3-5 minutes before taking measurements, take blood pressure from each arm and use the arm with the higher value as the reference, document the highest of at least two BP measurements taken from the reference arm at least 1-2 mins apart whilst in the sitting position)
3. Stroke risk factors (ethnicity, waist and hip circumference, diabetes, smoking, previous cardiovascular disease, diet, alcohol, stress, family history of cardiovascular disease);
4. Stroke risk score using Stroke Riskometer™ , where possible (this can be downloaded from Google Play [Android] or App Store [Apple], further details on www.strokeriskometer.com)
5. Antihypertensive treatment taken at the time of visit

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Systolic blood pressure is measured using an auscultatory or oscillometric semiautomatic sphygmomanometer at the study visit
2. Stroke risk is determined using Stroke Riskometer™ at the study visit
3. Antihypertensive use is determined through qualitative interviews at the study visit

Secondary outcome measures

No secondary outcomes

Overall trial start date

06/10/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥50 years* (*≥60 years in Columbia)
2. Confirmed (in medical records) diagnosis of hypertension
3. Elevated systolic blood pressure (≥ 140 mm Hg)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Participants = approx. 4350 total (4000 india, 200 Colombia, 150 Malaysia)

Participant exclusion criteria

Conditions that prevent participation in the study, such as the inability to complete the participant consent form.

Recruitment start date

01/03/2016

Recruitment end date

30/07/2016

Locations

Countries of recruitment

Colombia, India, Malaysia

Trial participating centre

Serdia Pharmaceuticals (India) Pvt. Ltd.
Serdia House off Dr. S. S. Rao Road, Parel
Mumbai
400 012
India

Sponsor information

Organisation

Servier International

Sponsor details

50 rue Carnot
Suresnes
Ile de France
92284
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

Not provided at time of registration.

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/09/2016: Internal review.