ISRCTN97503221进行中（未招募）4 期
OPtimising Treatment for MIld Systolic hypertension in the Elderly: a randomised controlled trial - long-term follow-up
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 569
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30287610 protocol (added 29/10/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32453368/ results (added 27/05/2020) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39094592/ long-term follow-up (added 06/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Added 04/07/2022:
- •Current inclusion is all original OPTiMISE trial participants unless they have opted out of longer-term follow-up.
- •Current inclusion criteria as of 04/05/2018, following HRA approval of Substantial Amendment 2 on 15/01/2018:
- •1. Participant is willing and able to give informed consent for participation in the trial
- •2. Male or female, aged 80 years or above
- •3. 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)
- •4. 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, beta-blocker, vasodilator antihypertensives, centrally acting antihypertensives, direct renin inhibitors, adrenergic neurone blocking drugs or loop diuretics.
- •5. Stable dose of antihypertensive medications for at least 4 weeks prior to trial entry.
- •6. 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)*
- •7. In the Investigator’s opinion, is able and willing to comply with all trial requirements.
- •*GPs will be given training from the research team during the site initiation visit on the findings of the SPRINT trial and other relevant trials and how these apply to patients in their practice.
- •Previous inclusion criteria:
- •1. Participant is willing and able to give informed consent for participation in the trial
- •2. Male or Female, aged 80 years or above
- •3. 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)
- •4. 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.
- •5. Stable dose of current antihypertensive medications for at least 4 weeks prior to trial entry.
- •6. 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)
- •7. In the Investigator’s opinion, is able and willing to comply with all trial requirements
排除标准
- •Exclusion criteria for the main trial:
- •1. 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).
- •2. 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).
- •3. Investigator deems that there is a compelling indication for medication continuation.
- •4. Suffered a myocardial infarction or stroke within the past 12 months.
- •5. Blood pressure being managed outside of primary care.
- •6. Secondary hypertension.
- •7. Previous accelerated or malignant hypertension.
- •8. Unable to provide consent unless a consultee is available to provide assent in cases of incapacity.
- •9. 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).
- •10. 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:
研究者
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