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

NCT06694688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • Orthostatic Hypotension

Interventions

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.

Sponsors & Collaborators

  • Thuasne

    collaborator INDUSTRY

  • Gérond'if

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-14
Primary Completion
2026-02-10
Completion
2026-02-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06694688 on ClinicalTrials.gov