Impact of Reducing Antihypertensive Treatment on Mortality in Frail Subjects With Low Systolic Bl… (NCT03453268) | Clinical Trial Compass
CompletedNot Applicable
Impact of Reducing Antihypertensive Treatment on Mortality in Frail Subjects With Low Systolic Blood Pressure (SBP).
France1,048 participantsStarted 2018-10-02
Plain-language summary
The investigators hypothesize that a gradual reduction in antihypertensive treatment in medical-social institutions patients with low systolic blood pressure (SBP) can improve survival through a controlled increase in SBP and a decrease in secondary morbidity due to 'overmedication'.
Accordingly, the investigators propose a randomized, case/control trial in NH patients ≥ 80 years with a SBP\<130 mmHg with \>1 anti-Htn drugs. This trial will consist of two parallel arms: the intervention arm will entail antihypertensive drug step-down, while the control arm will comprise the standard anti-hypertensive treatment.
Who can participate
Age range
80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients aged 80 and over
* Patients living in nursing homes
* Patients with a SBP \< 130 mmHg measured in Medical-Social Institutions using the connected blood pressure monitor supplied for the study (average of the last 2 out of 3 measurements after 10 min rest)
* Hypertensive patients whose treatment contains at least 2 antihypertensive molecules and whose treatment has been stabilised for at least :
* 3 weeks in the case of the introduction or discontinuation of an anti-HBP drug
* 2 weeks in the case of a change in the dosage of one of the anti-HBP drugs.
* Patients affiliated to a social security scheme
* Patients who have signed the informed consent form (failing which, the legal representative)
* Patients with dementia or with a severe reduction in physical function (impaired vision, asthenia, advanced osteoarthritis, severe tremors, etc.) and/or cognitive function may be included in this study with the agreement of their carers or family/relatives.
Exclusion Criteria:
* Patients in whom no antihypertensive molecule can be reduced for specific reasons (heart failure with ejection fraction \<40%, fluid retention due to heart failure, coronary artery disease and diabetic nephropathy).
* Patients with an estimated life expectancy of \<3 months
* Patients who have already been included in this study or in another study at the same time
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.