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| Name | Class |
|---|---|
| Thuasne | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a single group of patients | Other | 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 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the supine/standing postural change test | Diagnostic Test | The prevalence of orthostatic hypotension will be characterized by the percentage of patients with a decrease of ≥ 20mmHg in systolic blood pressure or ≥ 10mmHg in diastolic blood pressure following the supine/standing postural change position. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the blood pressure reduction induced by supine/standing postural change in the absence and presence of lower limb compression. | Decrease in systolic BP when moving from the supine to the standing position, using a semi-automatic blood pressure monitor (Dynamap type):
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in systolic blood pressure when moving from the supine to the upright position | The following evaluation criteria will be compared in the absence and presence of compression and between the different compression devices:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Broca Hospital | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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44 patients will be included in this study. Randomization will be carried out to determine the order of the 5 conditions studied:
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|
| 12 months |
| Severity of orthostatic hypotension | The severity of orthostatic hypotension will be assessed by the percentage of patients with an orthostatic systolic BP <90mmHg, following the supine/standing postural change position, - Symptoms associated with orthostatic hypotension will be assessed using the Orthostatic Hypotension Symptoms Assessment questionnaire (OHQ), consisting of 6 questions at the end of all pressure measurements. | 12 months |
| Characterize orthostatic hypotension | Characterize orthostatic hypotension at inclusion (neurogenic, hypovolemic, cardiogenic, drug-induced). | 12 months |
| Evaluate patient satisfaction and tolerance | Evaluate patient satisfaction and tolerance with the use of compression devices. | 12 months |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |