NCT06694688

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Gérond'if · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthostatic Hypotension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	the supine/standing postural change 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.

Timeline

• Start date: 2025-02-14
• Primary completion: 2026-02-10
• Completion: 2026-02-10
• First posted: 2024-11-19
• Last updated: 2026-04-03

Locations

1 site across 1 country: France