Study on the Effect of Aprepitant on Aldosterone Levels in Patients with Obstructive Sleep Apnea and High Blood Pressure

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What is this study about?

This clinical trial is focused on studying the effects of a medication called aprepitant on patients who have both obstructive sleep apnea and arterial hypertension. Obstructive sleep apnea is a condition where breathing repeatedly stops and starts during sleep, and arterial hypertension is another term for high blood pressure. The purpose of the study is to see how aprepitant affects the production of a hormone called aldosterone, which can influence blood pressure levels.

Participants in the study will be given aprepitant, which is known as a substance P antagonist. This means it works by blocking a specific receptor in the body that is involved in the production of certain hormones. The study will also use a placebo, which is a substance with no active medication, to compare the effects. Another substance involved in the study is lactose monohydrate, which is used as a tablet form. The study will be conducted over a period of time, with participants taking the medication orally, meaning by mouth.

Throughout the study, various measurements will be taken to assess the effects of the treatment. These include checking the levels of aldosterone in the body, as well as monitoring blood pressure and other related factors. The study aims to provide insights into how aprepitant can help manage conditions related to obstructive sleep apnea and high blood pressure by influencing hormone levels. Participants will be monitored closely to ensure their safety and to gather accurate data on the medication’s effects.

1 initial assessment

The study begins with an initial assessment to confirm eligibility. This includes verifying the presence of severe obstructive sleep apnea syndrome and arterial hypertension.

Eligibility is determined by an apnea and hypopnea index of 30 or more per hour, and blood pressure measurements of systolic blood pressure (SBP) 140 mmHg or higher and/or diastolic blood pressure (DBP) 90 mmHg or higher.

2 medication adjustment

If applicable, diuretics are replaced with another antihypertensive treatment that does not interfere with the renin-angiotensin system. This adjustment is necessary before starting the experimental treatment and continues throughout the study.

3 treatment period

The treatment involves taking aprepitant, a substance P antagonist, in the form of hard capsules. The specific dosage and frequency are determined by the study protocol.

The main objective is to evaluate the effect of aprepitant on aldosterone secretion.

4 monitoring and measurements

Throughout the study, various measurements are taken, including 24-hour aldosteronuria, blood pressure, aldosteronemia, reninemia, plasma and urinary electrolytes, 24-hour plasma and urinary cortisol, and plasma ACTH.

These measurements occur at the beginning and end of each treatment period to assess the effects of the medication.

5 completion of study

The study is estimated to conclude by April 19, 2026. Upon completion, final assessments are conducted to evaluate the outcomes of the treatment.

Who Can Join the Study?

Must have severe obstructive sleep apnea syndrome, which means having an apnea and hypopnea index (AHI) of 30 or more per hour, as shown by specific sleep tests.
Must have essential hypertension, which is high blood pressure that is either being treated with medication or lifestyle changes, or is newly diagnosed. This is defined by a systolic blood pressure (SBP) of 140 or more and/or a diastolic blood pressure (PAD) of 90 or more.
Must agree to replace any diuretics (medications that help remove excess water from the body) with another type of blood pressure medication that does not affect the body’s renin-angiotensin system, before starting the study treatment and throughout the study.
Must be an adult aged between 18 and 75 years old.
Must be affiliated with a social security scheme.
Must have read and understood the information letter and signed the consent form.
For women of childbearing age, must use effective mechanical contraception, like condoms, during the study and for two months after the last dose, and have a negative urine pregnancy test at the start and during the study.
For postmenopausal women, must have had no menstrual periods for at least 12 months before the first visit, and this should not be due to medical treatment.

Who Cannot Join the Study?

Patients who do not have obstructive sleep apnea syndrome. This is a condition where breathing stops and starts during sleep.
Patients who do not have arterial hypertension. This means high blood pressure.
Patients who are not within the specified age range for the study.
Patients who are not willing to follow the study procedures.
Patients who are pregnant or breastfeeding.
Patients who have other medical conditions that might interfere with the study.
Patients who are taking medications that could affect the study results.
Patients who have a history of allergic reactions to the study medication.
Patients who have participated in another clinical trial recently.
Patients who have a history of substance abuse.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Rouen	Rouen	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	05.03.2024

Trial locations

Investigated drugs:

Lactose Monohydrate

Aprepitant is a medication being studied for its potential to affect hormone levels in the body. In this trial, it is being used to see if it can influence the secretion of aldosterone, a hormone that helps regulate blood pressure and fluid balance. The study focuses on patients who have obstructive sleep apnea and high blood pressure. Aprepitant works by blocking a specific receptor in the body, which may help reduce the production of aldosterone.

Investigated diseases:

Obstructive Sleep Apnea Syndrome – This condition is characterized by repeated episodes of partial or complete blockage of the upper airway during sleep, leading to disrupted sleep and reduced oxygen levels in the blood. Individuals with this syndrome often experience loud snoring, gasping, or choking during sleep, and may feel excessively sleepy during the day. Over time, the repeated interruptions in breathing can lead to cardiovascular issues and other health problems. The condition is more common in individuals who are overweight, have a thick neck, or have certain structural abnormalities in the airway. It can affect people of all ages, but is more prevalent in middle-aged and older adults. Lifestyle changes and medical interventions can help manage the symptoms.

Arterial Hypertension – Also known as high blood pressure, this condition occurs when the force of the blood against the artery walls is consistently too high. It often develops over many years and can lead to serious health complications if left unmanaged. Many people with hypertension may not experience any symptoms, which is why it is often referred to as a “silent killer.” Over time, the increased pressure can damage blood vessels and organs, particularly the heart, brain, kidneys, and eyes. Risk factors include age, family history, obesity, lack of physical activity, and poor diet. Regular monitoring and lifestyle adjustments are crucial in managing this condition.

Trial ID:

2024-514837-39-00

Protocol code:

2020/0431/HP

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Aprepitant on Aldosterone Levels in Patients with Obstructive Sleep Apnea and High Blood Pressure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?