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?
Stéphane DUBOIS, Pharm.D.
(updated 07/08/2020, previously: Dr Harpreet Lhoste)
Trial website
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: Medical Research Ethics Committee, 02/08/2017
3. Colombia: no Ethics approval required
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 measure
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
30/06/2018
Reason abandoned (if study stopped)
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. 4242 total (3945 india, 208 Colombia, 89 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
Trial participating centre
Laboratorios Servier de Colombia SAS
Edificio 98-28
Transversal 19A# 98-28
Bogotá
Bogotá
-
Colombia
Trial participating centre
Servier Malaysia SDN. BHD.
Suite 1005, 10th Floor
Wisma Hamzah-Kwong Hing
Kuala Lumpur
50100
Malaysia
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
Basic results (scientific)
See additional files (ISRCTN95532888_BasicResults_06Aug2020) (added 06/08/2020)
Publication list
Publication citations
Additional files
- ISRCTN95532888_BasicResults_06Aug2020.pdf uploaded 06/08/2020