Clinical trial NCT06694688: Evaluation of the Contribution of Lower Limb And/or Abdominal Compression on Orthostatic Hypotension
Official title: Evaluation of the Contribution of Lower Limb And/or Abdominal Compression on Orthostatic Hypotension.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Orthostatic Hypotension
Keywords: orthostatic hypotention
abdominal compression
Lower limb compression
Lead sponsor: Gérond'if
Sponsor class: OTHER
Collaborators: name: Thuasne
First posted: 2024-11-19
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 44 patients will be included in this study. 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare the blood pressure reduction induced by supine/standing postural change in the absence and presence of lower limb compression.
timeFrame: 12 months
Secondary outcomes:
measure: Decrease in systolic blood pressure when moving from the supine to the upright position
timeFrame: 12 months
measure: Severity of orthostatic hypotension
timeFrame: 12 months
measure: Characterize orthostatic hypotension
timeFrame: 12 months
measure: Evaluate patient satisfaction and tolerance
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Broca Hospital
Study officials:
References: