Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Efficacy and Tolerance of Fludrocortisone (Flucortac) in the Treatment of Orthostatic Neurogenic Hypotension

Conditions
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Neurogenic Orthostatic Hypotension

Intervention / Treatment
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* Drug: Fludrocortisone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of orthostatic hypotension (HO), ie a blood pressure drop> 20 and / or 10 mmHg within 3 minutes after active and symptomatic lifting Patient suffering from a neurological disease orthostatic neurogenic hypotension persistent and symptomatic despite non-drug measures Exclusion Criteria: Hypersensitivity to FLU or any of its excipients non orthostatic neurogenic hypotension History of proven heart failure History of left ventricular systolic dysfunction Uncompensated hypokalemia Patient with poorly balanced Grade 3 hypertension Pregnant patient at the time of inclusion Nursing patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fludrocortisone<br>FLUCORTAC® 50 μg (tablet breackable). One tablet during the first week. Then 2 tablets during the second week. Then 3 tablets during the third week and finally 4 tablets during the 4th week. Maximum of 200μg/day. | Drug: Fludrocortisone<br>* 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<br>* Other names: Flucortac;|
| Placebo Comparator: Placebo<br>placebo of flucortac and same diagram of administration | Other: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic 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. | 8 weeks |