Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension

Neurogenic Orthostatic Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04128137
• Other study ID #: 2018-003905-25
• Status: Recruiting
• Phase: Phase 4
• Start date: July 9, 2020
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: H.A.C. PHARMA
• Contact: Catherine DENICOURT
• Phone: 02 31 47 92 46
• Email: catherine.denicourt[@]hacpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Neurogenic Orthostatic Hypotension

Intervention

Drug:
• Fludrocortisone
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

Other:
• Placebo
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

Locations

Country	Name	City	State
France	Hôpital Broca (AP-HP)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
H.A.C. PHARMA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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