PILOT STUDY OF THE EFFECT OF A SUBSTANCE P ANTAGONIST,APREPITANT, ON THE SECRETION OF ALDOSTERONE IN PATIENTS WITHOBSTRUCTIVE SLEEP APNEA AND ARTERIAL HYPERTENSION SYNDROME - (APHOS3)
- Conditions
- Patients with obstructive sleep apnea syndrome with arterialhypertensionTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2024-514837-39-00
- Lead Sponsor
- Centre Hospitalier Universitaire Rouen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
Subject with severe obstructive sleep apnea syndrome defined by an apnea and hypopnea index (AHI) = 30/h in polysomnography or ventilatory polygraphy (requiring continuous positive pressure equipment), Subject with essential hypertension treated medically or by lifestyle and dietary measures or newly diagnosed (defined by SBP = 140 and/or PAD = 90 mmHg according to current SFHTA-HAS recommendations), Patient's agreement to replace diuretics with another neutral antihypertensive treatment (which does not interfere with the reninangiotensin system) before taking the experimental treatment and throughout the study (if applicable), Regulatory Criteria: o Adult aged 18 to 75 / o Affiliation to a social security scheme / o Person who has read and understood the information letter and signed the consent form / o For women: - of childbearing age, need for effective mechanical contraception (condoms) during the study and within 2 months of the last month taken, with a negative urine pregnancy test on inclusion and for the duration of the study study at V2 and V4, - postmenopausal: amenorrhea not medically induced for at least 12 months before the V1 visit
Minor subject or subject over 75 years old, Criteria relating to associated pathologies leading to particular risks: o Subject with excessive daytime sleepiness with a contraindication to driving (Epworth score > 16) / o Severe uncontrolled cardiovascular disease: myocardial infarction or stroke in the last 6 months, unstable angina, heart failure. / o Knowledge of chronic renal failure defined by a glomerular filtration rate < 60 mL/min/1.73m2 for more than 3 months) or moderate hepatic failure defined by ALT and/or AST transaminases > 3N) / o Epilepsy o Known acute infections related to HIV, HBV or HCV / o Active cancer undergoing treatment or immunosuppressive treatments, Criteria for aprepitant: o Hypersensitivity to the active substance (aprepitant) or/and one of the excipients (contents and capsule shell) o People with hereditary problems of fructose intolerance, glucosegalactose malabsorption syndrome, or sucrase/isomaltase deficiency o Subject treated with drugs metabolized by cytochromes CYP3A4 and CYP2C9: corticosteroids (dexamethason, methylprednisolone), anti vitamin K (warfarin, acenocoumarol), benzodiazepines (midazolam, alprazolam, triazolam), anti-depressants (nefazodone), quinidine, hormonal contraceptives , ergot alkaloids (ergotamine, diergotamine), immunosuppressants (ciclosporin, tacrolimus, sirolimus, everolimus), morphine (alfentanil, fentanyl), antibiotics (rifampicin and clarithromycin-type macrolides, telithromycin), azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole), anti-virals (protease inhibitors), anti-epileptics (phenytoin, carbamazepine, phenobarbital), chemotherapies (etoposide, vinorelbine, ifosfamide, irinotecan), diuretics (tolbutamide) and herbal preparations containing St. John's wort. As well as these molecules in co-administration pimozide, terfenadine, astemizole and cisapride., Placebo contraindication criteria: Lactose intolerance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method