HYVET-2: Treatment of white coat HYypertension in the Very Elderly Trial (HYVET 2) - Feasibility of a randomised controlled trial

Phase 1

Active, not recruiting

• Conditions: White Coat Hypertension; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-004004-22-GB
• Lead Sponsor: niversity of Sussex

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-18
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Patients =75 years of age
•Clinic sitting systolic BP =150mmHg but <200mmHg and diastolic BP <110mmHg
•Diagnosis of white coat hypertension at baseline if the mean ambulatory day time average systolic BP is <135 mmHg and diastolic BP is <85mmHg (from at least 14 measurements) or for HBPM from BP readings twice a day for at least 5 days (ideally 7 days)at baseline
•Not taken antihypertensive drug therapy within the last 6 months
•Capacity to consent
•Provision of documented informed consent
•Ability to comply with the protocol and additional study visits & assessments

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Contraindication to the use of indapamide MR and perindopril in accordance with the summary of product characteristics
•Regular non-steroidal anti-inflammatory drug (NSAID) use. Regular use being defined by the local GP with consideration to cardiovascular risk and blood pressure
•Hypertensive emergency
•Secondary hypertension
•Postural hypotension (postural drop in systolic BP=20mmHg or postural symptoms at screening)
•Any stroke or myocardial infarction in the previous 6 months
•Heart failure requiring treatment with drugs having an antihypertensive effect
•Previous documented evidence of gout
•eGFR less than 30ml/min
•Montreal cognitive assessment score (MoCA) < 22
•Life expectancy <1year due to malignancy or chronic disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified