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

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

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.

Study Overview

• Status: Completed
• Conditions: Orthostatic Hypotension
• Intervention / Treatment: Diagnostic test: the supine/standing postural change test

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Broca Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: a single group of patients; 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 .	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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): supine BP: average of 3 measurements taken after a rest of at least 5 minutes; BP in upright position: lowest value of measurements obtained every minute for 5 minutes after rising, Without compression and with class 2 compression of the lower limbs.	12 months

Secondary Outcome Measures

Outcome Measure	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: The difference between supine SBP/DBP (average of last 3 measurements) and standing SBP/DBP (lowest value of 5 measurements) will be calculated,; The prevalence of orthostatic hypotension will be characterised by the percentage of patients with a decrease in systolic BP ≥ 20mmHg or ≥ 10mmHg in diastolic BP following the supine/standing postural change position,; The time to onset of orthostatic hypotension will be calculated from the 5 measurements of BP measured in orthostasis,	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

Collaborators and Investigators

• Sponsor: Gérond'if
• Collaborators: Thuasne

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Actual): February 10, 2026
• Study Completion (Actual): February 10, 2026

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: abdominal compression; orthostatic hypotention; Lower limb compression
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Hypotension; Hypotension, Orthostatic
• Other Study ID Numbers: 2024-A00027-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No