Optimising treatment for mild systolic hypertension in the elderly

Phase 1

Conditions: Hypertension
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-004236-38-GB

Lead Sponsor: niversity of Oxford

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 540

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

• patients aged >80 years.
• with controlled blood pressure (systolic blood pressure <150mmHg) (according to medical records).
• receiving =2 antihypertensive medications.
• no compelling indication for medication continuation.
• GP considers may benefit from medication reduction due to existing polypharmacy, co-morbidity and frailty.

Inclusion criteria for the qualitative study 2:
• Patients screened for the main trial
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 540

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.