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Evaluation of efficacy and tolerance of fludrocortisone (Flucortac) in the treatment of neurogenic orthostatic hypotension
EU CTIS ID: 2024-517841-16-00
What this study is testing
To evaluate the efficacy of a 4-week treatment with fludrocortisone (FLU) at stable dose on the decrease of systolic and diastolic blood pressure after 5 minutes of active orthostatism, in patients with neurogenic orthostatic hypotension
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age >18 years
- Orthostatic hypotension (blodo pressure decrease >20 and/or 10mmHg on systolic and diastolic values within 3 minutes after standup, and symptomatic according to the Orthostatic Hypotension Questionnaire OHQ: score different than 0 in at least 1 of the 6 items
- Patients suffering from a neurologic disease (Parkinson disease, multisystemic atrophy, Lewy bodies dementia, isolated progressive dysautonomia) or metabolic disease (diabetes, renal failure) known to be linked with an autonomous nervous system dysfunction and with NOH
- Persistant and symptomatic NOH despite the use of non-medicinal measures (lower limbs contention) and medicinal products (midodrine)
You likely can't join if
- Age <18 years
- Hypersensitivity to FLU or to one of its excipients
- Medical history of documented cardiac failure
- Medical history of left ventricular systolic dysfunction
- Non-compensated hypokalaemia
- Nocturnal or supine hypertension
See the full eligibility criteria
- Age >18 years
- Orthostatic hypotension (blodo pressure decrease >20 and/or 10mmHg on systolic and diastolic values within 3 minutes after standup, and symptomatic according to the Orthostatic Hypotension Questionnaire OHQ: score different than 0 in at least 1 of the 6 items
- Patients suffering from a neurologic disease (Parkinson disease, multisystemic atrophy, Lewy bodies dementia, isolated progressive dysautonomia) or metabolic disease (diabetes, renal failure) known to be linked with an autonomous nervous system dysfunction and with NOH
- Persistant and symptomatic NOH despite the use of non-medicinal measures (lower limbs contention) and medicinal products (midodrine)
- Age <18 years
- Hypersensitivity to FLU or to one of its excipients
- Medical history of documented cardiac failure
- Medical history of left ventricular systolic dysfunction
- Non-compensated hypokalaemia
- Nocturnal or supine hypertension
- Pregnant or breastfeeding patients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.