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Study on the Effects of Fludrocortisone in Treating Neurogenic Orthostatic Hypotension in Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as neurogenic orthostatic hypotension. This condition occurs when a person's blood pressure drops significantly upon standing, leading to symptoms like dizziness or fainting. The trial will evaluate the effectiveness and safety of a medication called fludrocortisone, which is marketed under the name Flucortac. Fludrocortisone is a type of medication that helps to increase blood pressure by retaining salt in the body, which can be beneficial for people with this condition.

The purpose of the study is to assess how well fludrocortisone works in managing the symptoms of neurogenic orthostatic hypotension over a period of four weeks. Participants will take the medication in tablet form, and their blood pressure will be monitored to see if there is an improvement when they move from lying down to standing up. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient.

Throughout the study, participants will be asked about their symptoms and overall quality of life to determine any changes. The study will also keep track of any side effects or unusual changes in blood pressure. This information will help researchers understand the potential benefits and risks of using fludrocortisone for treating neurogenic orthostatic hypotension.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying that you are over 18 years old and have been diagnosed with neurogenic orthostatic hypotension (NOH).
The assessment will also check if you have a neurologic or metabolic disease linked with NOH, such as Parkinson's disease or diabetes, and that your condition persists despite previous treatments.
Step 2
Medication administration
You will begin taking the medication fludrocortisone (Flucortac) in the form of a tablet. The dosage is 50 micrograms, taken orally.
The medication will be administered daily for a duration of four weeks. It is important to take the medication as directed to ensure the effectiveness of the treatment.
Step 3
Monitoring and evaluation
Throughout the trial, your blood pressure will be monitored to evaluate the effectiveness of the treatment. This involves measuring the decrease in systolic and diastolic blood pressure after standing for five minutes.
You will also be asked to complete the Orthostatic Hypotension Questionnaire (OHQ) to assess any symptoms related to NOH and to evaluate your quality of life using the SF36 scale.
Step 4
Reporting adverse events
During the trial, any adverse events or unusual symptoms should be reported. This includes any changes in your health or unexpected reactions to the medication.
Regular check-ins will be scheduled to collect information on any clinical adverse events, as well as any biological or blood pressure anomalies.
Step 5
Final assessment
At the end of the four-week period, a final assessment will be conducted to evaluate the overall effectiveness of the treatment.
This will include a review of your blood pressure measurements, symptom evaluations, and any reported adverse events to determine the success of the treatment.

Who can join the trial?

4 criteria

Must be over 18 years old.
Must have orthostatic hypotension, which means a drop in blood pressure of more than 20 mmHg (systolic) or 10 mmHg (diastolic) within 3 minutes of standing up, and must have symptoms according to the Orthostatic Hypotension Questionnaire (OHQ). This means having a score different from 0 in at least one of the six items on the questionnaire.
Must have a neurologic disease such as Parkinson's disease, multisystemic atrophy, Lewy bodies dementia, or isolated progressive dysautonomia, or a metabolic disease like diabetes or kidney failure, which are known to be linked with problems in the autonomic nervous system and with neurogenic orthostatic hypotension.
Must have persistent and symptomatic neurogenic orthostatic hypotension despite using non-medicinal measures like compression stockings for the legs and medicinal products like midodrine.

Who cannot join the trial?

8 criteria

Patients who do not have neurogenic orthostatic hypotension cannot participate. This is a condition where blood pressure drops significantly when standing up, due to nerve problems.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fall within the eligible age group.
Patients who are not part of the specified clinical trial group cannot participate. This refers to specific groups of people the study is focusing on.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate. This means if you have other health issues that could affect the study results, you may not be eligible.
Patients who are taking medications that might interfere with the study cannot participate. This means if you are on certain drugs that could affect the study, you may not be eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently cannot participate. This is to ensure that previous treatments do not affect the results of this study.

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Verified sites

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Centre Hospitalier Et Universitaire De Limoges
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Limoges, France
Centre Hospitalier Lyon Sud
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Pierre Benite, France
Centre Hospitalier Regional D'Angers
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Angers, France

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Investigated drugs

Fludrocortisone is a medication used in this clinical trial to help treat a condition called neurogenic orthostatic hypotension. This condition causes a person's blood pressure to drop significantly when they stand up, which can lead to dizziness or fainting. Fludrocortisone works by helping the body retain salt, which in turn helps increase blood volume and raise blood pressure. In this trial, the goal is to see how effective and well-tolerated fludrocortisone is over a four-week period in managing the blood pressure of patients with this condition.

Fludrocortisone Acetate

What is already known about the treatment

Fludrocortisone (Flucortac) – Fludrocortisone is administered orally in the form of tablets. It is currently being studied for its effectiveness in treating neurogenic orthostatic hypotension, a condition where blood pressure drops significantly when standing up. The medication works by helping the body retain sodium, which increases blood volume and helps maintain blood pressure. Fludrocortisone is classified as a corticosteroid, which is a type of medication that mimics hormones produced by the adrenal glands.

Investigated diseases

Neurogenic Orthostatic Hypotension – Neurogenic Orthostatic Hypotension is a condition characterized by a significant drop in blood pressure when a person moves from lying down to a standing position. This drop in blood pressure is due to a malfunction in the autonomic nervous system, which fails to regulate blood pressure properly. As a result, individuals may experience dizziness, lightheadedness, or even fainting upon standing. The condition progresses as the autonomic nervous system continues to inadequately respond to postural changes, leading to persistent symptoms. Over time, the frequency and severity of these symptoms can increase, affecting daily activities. The condition is often associated with other neurological disorders that impact the autonomic nervous system.