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

Gérond'if

Status: Enrolling

Conditions: Orthostatic Hypotension

Treatments: Diagnostic Test: the supine/standing postural change test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06694688

2024-A00027-40

Details and patient eligibility

About

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.

Full description

Patients will be recruited from a single center, over a 12-month inclusion period. The clinical investigation will focus on CE-marked Class I medical devices, used for their intended purpose, as part of a post-market clinical follow-up with additional non-invasive, non-invasive procedures. Randomization will be carried out to determine the order of the 5 conditions studied:

• No compression,
• Class 2 compression socks,
• Class 3 compression socks,
• Class 2 compression tights,
• Dynabelt abdominal belt + Class 2 compression socks. Conditions will be tested over half a day.

Enrollment: 44 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

a single group of patients

Other group

Description:

Subject will undergo the following 5 conditions in the cross-over scheme as determined by the randomization: No compression, Class 2 compression socks, Class 3 compression socks, Class 2 compression tights and Dynabelt abdominal belt + Class 2 compression socks .

Treatment:

Diagnostic Test: the supine/standing postural change test