Actively Recruiting
Pilot Study of the Effect of a Substance P Antagonist, Aprepitant, on Aldosterone Secretion in Patients with Obstructive Sleep Apnea Syndrome and Arterial Hypertension
Led by University Hospital, Rouen · Updated on 2026-05-11
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the role of hyperaldosteronism in patients with obstructive sleep apnea syndrome (OSAS) and arterial hypertension. This study explores how hyperaldosteronism, which increases arterial stiffness and heart rate variability, may be influenced by nervous system control involving substance P and the NK1 receptor. The study aims to evaluate whether blocking this receptor with aprepitant reduces aldosterone secretion in these patients. Participants will receive either aprepitant or a placebo in a randomized, single-blind setting. The aprepitant group takes oral capsules once daily for four days, starting with 125 mg on day one followed by 80 mg on subsequent days. The placebo group receives matching capsules on the same schedule. The primary focus is to measure the rate of aldosterone secretion immediately after intervention. During the study, participants will undergo assessments to monitor aldosterone levels and related cardiovascular markers. Researchers will track blood pressure and heart function while ensuring adherence to treatment protocols, including replacing certain antihypertensive medications and avoiding licorice products. The study includes follow-up to evaluate the impact of the treatment on aldosterone secretion and related cardiovascular parameters over the study period.
CONDITIONS
Brief Title
EFFECT OF A SUBSTANCE P ANTAGONIST ON THE SECRETION OF ALDOSTERONE IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME AND ARTERIAL HYPERTENSION
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Severe obstructive sleep apnea syndrome (AHI 6 30/h) confirmed by polysomnography or ventilatory polygraphy requiring continuous positive airway pressure
- Essential hypertension treated medically, by lifestyle/dietary measures, or newly diagnosed (SBP 6 140 and/or DBP 6 90 mmHg)
- Agreement to replace diuretics with a neutral antihypertensive treatment and to stop consuming licorice and derivatives 7 to 10 days before and during the study
You will not qualify if you...
- Age under 18 or over 75 years
- Excessive daytime sleepiness with contraindication to driving (Epworth score > 16)
- Uncontrolled severe cardiovascular disease including recent myocardial infarction or stroke (within 6 months), unstable angina, significant valvular heart disease, heart failure (NYHA class 6 II), uncontrolled arrhythmia or conduction abnormalities
- Chronic renal insufficiency with glomerular filtration rate < 60 mL/min/1.73m2 for more than 3 months
- Moderate hepatic insufficiency (ALT and/or AST > 3 times normal)
- Epilepsy
- Known acute infections linked to HIV, HBV, or HCV
- Active cancer currently being treated
- Contraindications to placebo and aprepitant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 days per treatment period
Participants receive aprepitant or placebo capsules once daily for 4 days in a randomized crossover design.
1 visit per treatment period (in-person)
Trial Site Locations
Total: 1 location
1
CHU de Rouen
Rouen, France, France, 76000
Actively Recruiting
Research Team
A
Antoine-Guy Lopez
N
Nell Marty
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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