Neurogenic Orthostatic Hypotension
Conditions
Brief summary
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
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.
Interventions
DRUGFludrocortisone
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
OTHERPlacebo
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
Sponsors
H.A.C. PHARMA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic BP diminution | 8 weeks | 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. |
Countries
France
Contacts
Primary ContactCatherine DENICOURT
Outcome results
None listed