Last updated: September 14, 2023
Sponsor: East Kent Hospitals University NHS Foundation Trust
Overall Status: Completed
Phase
N/A
Condition
Vascular Diseases
Circulation Disorders
Williams Syndrome
Treatment
Standard care lifestyle advice
Isometric Exercise
Clinical Study ID
NCT04936022
NIHR200485
13472393
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18 or over
- Clinic systolic BP 140-159 mmHg
- Able to provide informed consent
Exclusion
Exclusion Criteria:
- Currently taking anti-hypertensive medication
- White coat hypertension, as evidenced by averaged home systolic BP <135 mmHg
- Inability to undertake study intervention (isometric exercise)
- Previous history of any of the following:
- Diabetes mellitus (Type 1 or type 2)
- Ischaemic heart disease (myocardial infarction and/or coronary angina and/orcoronary revascularization procedure)
- Moderate or severe stenotic or regurgitant heart valve disease
- Atrial or ventricular arrhythmia
- Stroke or transient ischaemic attack
- Aortic aneurysm and/or peripheral arterial disease
- Uncorrected congenital or inherited heart condition
- Estimated glomerular filtration rate <45 ml/min (calculated using CKD-EPI or MDRDformulae, and taking most recent documented results)
- Documented left ventricular ejection fraction <45% and/or left ventricular hypertrophy (by either echocardiography or standard ECG criteria e.g. Sokolow-Lyon)
- Documented urine albumin:creatinine ratio >3.5 mg/mmol
- Inability to provide informed consent
- If female, pregnancy or currently breast feeding
- Enrolled in another Clinical Trial of an Interventional Medicinal Product or MedicalDevice or other interventional study
- Medical condition that, in the opinion of the investigator, would make the participantunsuitable for the study
Study Design
Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Standard care lifestyle advice
Phase:
Study Start date:
February 01, 2020
Estimated Completion Date:
November 30, 2022
Connect with a study center
Canterbury Medical Practice
Canterbury, Kent CT45BL
United KingdomSite Not Available
Kent and Canterbury Hospital
Canterbury, Kent
United KingdomSite Not Available
Northgate Medical Practice
Canterbury, Kent CT11WL
United KingdomSite Not Available
Newton Place Surgery
Faversham, Kent ME138FH
United KingdomSite Not Available
St Helier Hospital
Carshalton, Surrey SM51AA
United KingdomSite Not Available
Maywood Healthcare Centre
Bognor Regis, West Sussex PO212UW
United KingdomSite Not Available
Brighton Health and Wellbeing Centre
Hove, BN31AE
United KingdomSite Not Available

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