Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension

Phase 4

Recruiting

• Conditions: Neurogenic Orthostatic Hypotension
• Interventions: Other: Placebo; Drug: Fludrocortisone

• Registration Number: NCT04128137
• Lead Sponsor: H.A.C. PHARMA

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.

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2020-07-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo of flucortac and same diagram of administration
fludrocortisone	Fludrocortisone	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital Broca (AP-HP); 🇫🇷 Paris, France