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

NCT06694688 | Recruiting DMC

• 1 other identifier: 2024-A00027-40
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Orthostatic Hypotension

Keywords

orthostatic hypotention; abdominal compression; Lower limb compression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Decrease in systolic blood pressure when moving from the supine to the upright position

  12 months

• Severity of orthostatic hypotension

  12 months

• Characterize orthostatic hypotension

  12 months

• Evaluate patient satisfaction and tolerance

  12 months

Study Arms (1)

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 .

Diagnostic Test: the supine/standing postural change test

Interventions

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.

a single group of patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gérond'if: lead
• Thuasne: collaborator

Study Sites (2)

Broca Hospital

Paris, 75013, France

NOT YET RECRUITING

Broca Hospital

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

ISABELLE DUFOUR

CONTACT

33 (0) 185781011; isabelle.dufour@gerondif.org

Prisca LUCAS, Ph.D & MPH

CONTACT

33 (0) 185737323; prisca.lucas@gerondif.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 19, 2024
• Study Start: February 14, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)