To evaluate the efficacy of a 4-week fludrocortisone (FLU) treatment on systolic blood pressure depression after 5 minutes of active orthostatism in patients with neurogenic orthostatic hypotension (HON) symptomatic, despite treatment with non-drug measures with or without midodrine.
The objective of the study is to demonstrate the efficacy of FLU on systolic blood pressure depression in patients with neurogenic orthostatic hypotension. The study is randomised versus placebo.Each patient will be followed for a maximum of 5 months, with no more than 8 visits to the investigator (V0 at Day-7, V1 at D0, V2 at D7, V3 at D+14, V4 at D+21, V5 at D+ 28, V6 at D+56 and V7 only for patients on the FLU arm at D+140. The presence of a comparator control group with placebo permits to evaluate the efficacy and the tolerance of FLU independently of the natural evolution of the pathology, in patients benefiting from a non-drug or possibly medicated treatment (midodrine) but insufficient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
50 µg/day during one week then augmentation of 50 µg each weeks until a maximum dose of 200 µg/day. And a maintenance phase of 4 weeks at a stable dose
50 µg/day during one week then augmentation of 50 µg each weeks until a maximum dose of 200 µg/day. And a maintenance phase of 4 weeks at a stable dose
Hôpital Broca (AP-HP)
Paris, France
RECRUITINGSystolic BP diminution
Systolic BP diminution when moving from supine to standing, measured with a semi-automatic blood pressure monitor \- AP in upright position: the lowest value of the measurements obtained every minute, for 5 minutes after rising.
Time frame: 8 weeks
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