Study evaluating uncontrolled systolic blood pressure in middle-aged and older patients with high blood pressure
| ISRCTN | ISRCTN95532888 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95532888 |
| Secondary identifying numbers | DIM-05520-001 |
- Submission date
- 21/07/2016
- Registration date
- 08/09/2016
- Last edited
- 07/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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)
Contact information
Public
Global Medical Affairs - GMA Cardiology
35 rue Verdun
Suresnes Cedex
92284
France
Study information
| Study design | Multi-centre multi-country cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | SYSTUP |
| Study objectives | 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(s) | 1. India: Lancelot Independent Ethics Committee, 23/12/2015 2. Malaysia: Medical Research Ethics Committee, 02/08/2017 3. Colombia: no Ethics approval required |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 06/10/2015 |
| Completion date | 30/06/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Participants = approx. 4242 total (3945 india, 208 Colombia, 89 Malaysia) |
| Key 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) |
| Key exclusion criteria | Conditions that prevent participation in the study, such as the inability to complete the participant consent form. |
| Date of first enrolment | 01/03/2016 |
| Date of final enrolment | 30/07/2016 |
Locations
Countries of recruitment
- Colombia
- India
- Malaysia
Study participating centres
off Dr. S. S. Rao Road
Parel
Mumbai
400 012
India
Transversal 19A# 98-28
Bogotá
Bogotá
-
Colombia
Wisma Hamzah-Kwong Hing
Kuala Lumpur
50100
Malaysia
Sponsor information
Industry
50 rue Carnot
Suresnes
Ile de France
92284
France
"ROR" |
https://ror.org/034e7c066 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Not provided at time of registration. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 06/08/2020 | 06/08/2020 | No | No |
Additional files
- ISRCTN95532888_BasicResults_06Aug2020.pdf
- uploaded 06/08/2020
Editorial Notes
07/08/2020: The main contact was changed in the plain English summary.
06/08/2020: The following changes were made to the trial record:
1. The target number of participants was changed from "Participants = approx. 4350 total (4000 india, 200 Colombia, 150 Malaysia)" to "Participants = approx. 4242 total (3945 india, 208 Colombia, 89 Malaysia)".
2. A public contact was removed.
3. The trial participating centres Laboratorios Servier de Colombia SAS and Servier Malaysia SDN. BHD. were added.
4. The basic results of this trial have been uploaded as an additional file.
13/12/2017: Dr Harpreet Lhoste (harpreet.lhoste@servier.com) has been removed as a study contact. Nathalie Barbet (nathalie.barbet@servier.com) and Romualda Villatte (romualda.villatte@Servier.com) have been added. Ethics approval information has been updated. The overall trial end date has been updated from 31/12/2016 to 30/06/2018.
19/09/2016: Internal review.
