Orthostatic HypotensionHYPOFLEXNCT06694688
Evaluation of the Contribution of Lower Limb and/or Abdominal Compression on Orthostatic Hypotension
A study testing the supine/standing postural change test in people with Orthostatic Hypotension, run by Gérond'if at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- the supine/standing postural change test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- the supine/standing postural change test
- Keywords
- orthostatic hypotention, abdominal compression, Lower limb compression
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the supine/standing postural change testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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
. Receives: Diagnostic Test: the supine/standing postural change test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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,
Measured: 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.
Measured: 12 months
Characterize orthostatic hypotension
Characterize orthostatic hypotension at inclusion (neurogenic, hypovolemic, cardiogenic, drug-induced).
Measured: 12 months
Evaluate patient satisfaction and tolerance
Evaluate patient satisfaction and tolerance with the use of compression devices.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start14 Feb 2025
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Collaborators
- Thuasne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694688
- Sponsor's protocol ID
- 2024-A00027-40
- Acronym
- HYPOFLEX
- Status last verified
- Feb 2026
- First submitted
- 8 Nov 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Contribution of Lower Limb and/or Abdominal Compression on Orthostatic Hypotension.
- ClinicalTrials.gov ID
- NCT06694688
- Acronym / sponsor ID
- HYPOFLEX / 2024-A00027-40
- Conditions
- Orthostatic Hypotension
- Keywords
- orthostatic hypotention, abdominal compression, Lower limb compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Collaborators
- Thuasne
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| a single group of patients | Other | Diagnostic Test: the supine/standing postural change testSubject 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 . |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the supine/standing postural change testThe 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. | Diagnostic test | a single group of patients |
Primary outcome
Compare the blood pressure reduction induced by supine/standing postural change in the absence and presence of lower limb compression.
Time frame: 12 months
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.
4 secondary outcomes
Decrease in systolic blood pressure when moving from the supine to the upright position
Time frame: 12 months
Severity of orthostatic hypotension
Time frame: 12 months
Characterize orthostatic hypotension
Time frame: 12 months
Evaluate patient satisfaction and tolerance
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the supine/standing postural change test in people with Orthostatic Hypotension, run by Gérond'if at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the blood pressure reduction induced by supine/standing postural change in the absence and presence of lower limb compression. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.