Broca Hospital
Paris, 75013, France
NCT Number: NCT06694688
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.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Paris, 75013, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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):
Time frame: 12 months
The following evaluation criteria will be compared in the absence and presence of compression and between the different compression devices:
Time frame: 12 months
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,
Time frame: 12 months
Characterize orthostatic hypotension at inclusion (neurogenic, hypovolemic, cardiogenic, drug-induced).
Time frame: 12 months
Evaluate patient satisfaction and tolerance with the use of compression devices.
Gérond'if
Other
Evaluation of the Contribution of Lower Limb and/or Abdominal Compression on Orthostatic Hypotension.
Acronym: HYPOFLEX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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