UnknownPhase 4

Efficacy and Tolerance of Flucortac in Patients With Orthostatic Neurogenic Hypotension

France90 participantsStarted 2020-07-09

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Systolic BP diminution

Timeframe: 8 weeks

Trial details

NCT IDNCT04128137

SponsorH.A.C. PHARMA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06

Contact for this trial

Catherine DENICOURT

02 31 47 92 46 catherine.denicourt@hacpharma.com

View on ClinicalTrials.gov More Neurogenic Orthostatic Hypotension trials

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.