Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension

  • STATUS
    Recruiting
  • End date
    Oct 24, 2021
  • participants needed
    90
  • sponsor
    H.A.C. PHARMA
Updated on 24 January 2021

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.

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.

Details
Condition Neurogenic Orthostatic Hypotension
Treatment Placebo, Fludrocortisone
Clinical Study IdentifierNCT04128137
SponsorH.A.C. PHARMA
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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