Study evaluating uncontrolled systolic blood pressure in middle-aged and older patients with high blood pressure

• Register: ISRCTN
• Last refreshed on: 17 August 2020
• Main ID: ISRCTN95532888
• Date of registration: 08/09/2016
• Prospective Registration: No
• Primary sponsor: Servier International
• Public title: Study evaluating uncontrolled systolic blood pressure in middle-aged and older patients with high blood pressure
• 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
• Date of first enrolment: 01/03/2016
• Target sample size: 4242
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN95532888
• Study type: Observational
• Study design: Multi-centre multi-country cross-sectional study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Colombia, India, Malaysia

Contacts

• Name: Nathalie Barbet

Key inclusion & exclusion criteria

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)

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

Primary Outcome(s)

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(s)

No secondary outcomes

Secondary ID(s)

DIM-05520-001

Source(s) of Monetary Support

Servier International

Ethics review

Status:
Approval date:
Contact:

1. India: Lancelot Independent Ethics Committee, 23/12/2015 2. Malaysia: Medical Research Ethics Committee, 02/08/2017 3. Colombia: no Ethics approval required

Results

• Results available: Yes
• Date Completed: 30/06/2018