Hypertension
Conditions
Interventions
Product Name: Medication withdrawal
Product Code: Not applicable
Pharmaceutical Form:
INN or Proposed INN: Not applicable
Other descriptive name: Not applicable
Concentration unit: Other
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the main trial: • Participant is willing and able to give informed consent for participation in the trial. • Male or Female, aged 80 years or above. • Clinic systolic blood pressure less than 150 mmHg (according to screening measurement at baseline – clinic blood pressure defined as the mean of the 2nd and 3rd readings taken at 1 minute intervals). • Prescribed two or more antihypertensive medications to lower blood pressure for at least 12 months prior to trial entry. Antihypertensive medications defined as any ACE inhibitor, angiotensin II receptor blocker, calcium channel blocker, thiazide and thiazide-like diuretic, potassium-sparing diuretic, alpha-blocker or beta-blocker. • Stable dose of current antihypertensive medications for at least four weeks prior to trial entry. • In the Investigator’s opinion, could potentially benefit from medication reduction due to existing polypharmacy, co-morbidity, non-adherence or dislike of medicines and/or frailty (i.e. is different from those to which the results of the SPRINT trial are likely to apply). • In the Investigator’s opinion, is able and willing to comply with all trial requirements. Inclusion criteria for the qualitative study 1: • GPs from practices within the Cambridgeshire study region or • patients aged >80 years. • with controlled blood pressure (systolic blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range 540
Exclusion criteria
Exclusion criteria: Exclusion criteria for the main trial: • A participant has heart failure due to LVSD and is on only ACE inhibitors/ARBs and/or beta-blockers and/or spironolactone (removing any of which would be contraindicated). • A participant has heart failure but has not had an echocardiogram since its onset (might have undiagnosed LVSD and a compelling need for ACEI/ARB and Betablockers). • Investigator deems that there is a compelling indication for medication continuation. • Suffered a myocardial infarction or stroke within the past 12 months. • Blood pressure being managed outside of primary care. • A participant with secondary hypertension. • A participant with previous accelerated or malignant hypertension. • Unable to provide consent unless a consultee is available to provide assent in cases of incapacity. • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial (e.g. terminal illness, house bound and unable to attend baseline and follow up clinics). • Participants who have participated in another research trial involving antihypertensive medication in the past 4 weeks. Exclusion criteria for the qualitative study 1: • Capacity to consent and participate in an interview Exclusion criteria for the qualitative study 2: • None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if a reduction in medication can achieve a proportion of patients with clinically safe levels (defined as a systolic blood pressure <150mmHg) which is non-inferior (within 10%) to that achieved by the usual care group.;Secondary Objective: Determine the proportion of patients in intervention arm who maintain medication reduction through to follow-up (i.e. are not restarted on therapy) Determine the difference in quality of life (according to EQ-5D-5L) between groups at 12 follow-up. Determine the difference in frailty (according to the FRAIL scale/frailty index) between the two groups at 12 week follow-up. Determine the difference in the change in mean clinic systolic blood pressure (from baseline) between the two groups at 12 week follow-up. Determine the difference in reported potential side effects to medication between the two groups at 12 week follow-up (e.g. coughs, dizziness, syncope, ankle swelling, etc.). Determine the difference in routinely reported adverse events between the two groups at 12 week follow-up (hospitalisation due to falls, myocardial infarction, stroke or all-cause mortality). Determine the characteristics (e.g. age, gender, ethnicity, medical history) of the baseline screening and sample ;Primary end point(s): The proportion of patients with controlled systolic blood pressure levels (systolic blood pressure <150mmHg) at 12 week follow-up.;Timepoint(s) of evaluation of this end point: 12 weeks (+/-2 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients randomized to the intervention arm who maintain medication reduction throughout 12 week follow-up. EQ-5D-5L score at 12 week follow-up. FRAIL scale score/frailty index at 12 week follow-up. The proportion of patients reporting possible side effects to medication (e.g. coughs, dizziness, syncope, ankle swelling, etc.). The proportion of patients reporting adverse events (hospitalisation due to serious falls, myocardial infarction, stroke or all-cause mortality). Exploratory analyses examining blood pressure control, change in blood pressure and maintenance of medication reduction at 12 months, by frailty, functional independence, cognitive function, number of antihypertensive medications and co-morbidities at baseline. Further quantitative, qualitative and economic analyses will examine: • Descriptive statistics of the screening and baseline population • Comparison of these characteristics with those eligible/not eligible for the SPRINT trial • Thematic analysis of chart-stimulated interviews with GPs • Thematic analysis of ‘Brown bag’ medication review interviews with patients. • Cardiovascular disease risk, costs and quality-adjusted-life years. ;Timepoint(s) of evaluation of this end point: 12 weeks (+/-2 weeks) | — |
Countries
United Kingdom
Contacts
Public ContactJames Sheppard
University of Oxford
Outcome results
None listed