CompletedNot Applicable

Evaluation of the Contribution of Lower Limb and/or Abdominal Compression on Orthostatic Hypotension

France43 participantsStarted 2025-02-14

Plain-language summary

Orthostatic hypotension (OH) is associated with an increased risk of myocardial infarction, stroke, heart failure and neurocognitive disorders. In the elderly, OH is an independent predictor of falls and mortality. Non-drug treatments are used as the first-line treatments. Among non-drug treatments, compression of the lower limbs and abdominal compression have been shown to help reduce OH and associated symptoms. As these studies were solely based on ankle-to-thigh bandages, the effectiveness of other medical devices developed, such as compression socks and tights, needs to be evaluated. In addition, data comparing the efficacy and tolerability of several approaches, single or combined, of several levels of compression, provided by socks, tights and an abdominal belt are scarce. The HYPOFLEX study aims to provide new data to enable better management of OH.

Who can participate

Age range

60 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: * Patient aged 60 or over, * Patients hospitalized at Broca Hospital with orthostatic hypotension, * Patient able to stand, * Patient who has been medically stable for at least 48 hours, * Patient whose measurements are compatible with Thuasne compression device sizes, * Patient having been informed, having received answers to his questions and having signed the informed consent form prior to his participation in the study, * Patient affiliated or entitled to a social security number. Exclusion Criteria: * Patients presenting, according to the investigator, a contraindication to lower limb and/or abdominal compression, * Patients presenting any contraindication mentioned in the instructions for use of the medical devices under investigation. * Patient presenting, according to the investigator, a major cognitive impairment incompatible with participation in a clinical trial, * Patient taking part in another clinical investigation conducted to establish the conformity of a medical device having an impact on the outcomes, * Vulnerable patient according to article L1121-6 of the Public Health Code, subject to a judicial protection measure or incapable of consenting to a clinical trial or incapable of giving informed consent.

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.

What they're measuring

Compare the blood pressure reduction induced by supine/standing postural change in the absence and presence of lower limb compression.

Timeframe: 12 months

Trial details

NCT IDNCT06694688

SponsorGérond'if

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-10

View on ClinicalTrials.gov More Orthostatic Hypotension trials