White Coat Hypertension
Conditions
Interventions
Trade Name: ALKAPAMID XL 1.5mg prolonged release tablets
Product Name: ALKAPAMID XL 1.5mg prolonged release tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Indapamide
Concentration unit: mg m
Sponsors
University of Sussex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients =75 years of age • Clinic sitting systolic BP =150mmHg but =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a feasibility study, which serves as a prelude to a definitive randomised controlled trial to determine whether the treatment of WCH in the very elderly outweighs any adverse events. The primary research question is: Will it be feasible to conduct a study treating WCH in a cohort of older people? To answer the above question, this feasibility study will focus on the following outcomes: 1. The proportion of eligible patients that can be recruited from initial screening 2. An exploration of different methods of identifying/recruiting patients including preliminary experience using the National Institute for Health Research/Clinical Research Network recruitment methods 3. The willingness of GPs to recruit and randomise patients 4. The willingness of patients to be randomised 5. Recruitment rate 6. Adherence to the treatment protocol 7. Withdrawal from the clinical trial 8. Expanding the opportunities for PPI (patient and public involvement) in the research design and its subseque;Secondary Objective: As this is a feasibility trial there are no secondary objectives;Primary end point(s): This is a feasibility study, which serves as a prelude to a definitive randomised controlled trial, in order to determine whether the treatment of WCH in the very elderly is feasible and outweighs any adverse events. This feasibility study will focus on the following outcomes: 1. The proportion of eligible patients that can be recruited from initial screening 2. An exploration of different methods of identifying/recruiting patients including preliminary experience using the National Institute for Health Research/Clinical Research Network recruitment methods 3. The willingness of GPs to recruit and randomise patients 4. The willingness of patients to be randomised 5. Recruitment rate 6. Adherence to the treatment protocol 7. Withdrawal from the clinical trial 8. Expanding the opportunities for PPI (patient and public involvement) in the research design and its su | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As this is a feasibility study there are no secondary end points;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
United Kingdom
Contacts
Public ContactNicky Perry
Brighton and Sussex Clinical Trials Unit
Outcome results
None listed