Evaluating Fludrocortisone for Neurogenic Orthostatic Hypotension
Evaluation of Efficacy and Tolerance of Fludrocortisone (Flucortac) in the Treatment of Orthostatic Neurogenic Hypotension
PHASE4 · H.A.C. PHARMA · NCT04128137
This study is testing if the medication fludrocortisone can help people with neurogenic orthostatic hypotension feel better when they stand up, especially if other treatments haven't worked for them.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | H.A.C. PHARMA (industry) |
| Locations | 1 site (Paris) |
| Trial ID | NCT04128137 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy of fludrocortisone (FLU) in treating patients with neurogenic orthostatic hypotension who continue to experience symptoms despite non-drug interventions. It is a randomized, placebo-controlled trial where participants will be monitored over a maximum of five months with multiple follow-up visits. The primary focus is on measuring changes in systolic blood pressure after standing for five minutes. The study will help determine the effectiveness and safety of FLU compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with neurogenic orthostatic hypotension who are symptomatic despite non-drug treatments.
Not a fit: Patients with non-orthostatic neurogenic hypotension or those with certain cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve blood pressure stability and quality of life for patients with neurogenic orthostatic hypotension.
How similar studies have performed: Previous studies have shown promising results with fludrocortisone in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Hôpital Broca (AP-HP) — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Jean-Michel SENARD, MD — National Coordinator
- Study coordinator: Catherine DENICOURT
- Email: catherine.denicourt@hacpharma.com
- Phone: 02 31 47 92 46
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurogenic Orthostatic Hypotension