BOSENTAN for Uncontrolled arterial hypertension

Inclusion criteria

• {"criterion_text":"- age between 30 and 80 years old\n- Patients with uncontrolled hypertension defined according to the criteria recognized by the French Society of Hypertension (SFHTA): arterial pressure greater than or equal to 140 and / 90 mm Hg in a medical clinic.\n- Patients with uncontrolled hypertension confirmed by selfmeasurement (≥135 / 85 mmHg on average) or by ambulatory blood pressure measurement (mean of 24h ≥130 / 80 mmHg).\n- Hemoglobin level > 11 g / dL\n- For women of childbearing potential, reliable methods of contraception (as defined by the WHO-Pearl Index) should be used (hormonal contraception should not be the only contraceptive method used during bosentan treatment).\n- For postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months and age greater than 45, before the inclusion visit)\n- Patient who read and understood the newsletter and signed the consent form\n- Patient affiliated to a social security scheme"}

Exclusion criteria

• {"criterion_text":"- Patients with secondary hypertension other than sleep apnea syndrome or stage 2 or 3 chronic renal failure. Are sought: - stenosis of the renal arteries for subjects under 50 years old. - primary hyperaldosteronism, an endocrine cause (hypercortisolism, pheochromocytoma), a toxic cause (consumption of glycerrhizide, cannabis drugs, heroin, treatments with anti-inflammatories, corticosteroids), a genetic cause (Liddle syndrome) for subjects under the age of 40 years.\n- Patient with unbalanced diabetes (HbA1c >7.5%)\n- Patient with proteinuria > 1g/g creatininuria\n- Orthostatic hypotension (decrease in SBP > 20mmHg and/or DBP >10 mmHg occurring within 3 minutes following standing).\n- Contraindication to NATISPRAY 0.30 mg/dose, solution for oral spray: - Hypersensitivity to nitrates or to one of the excipients. - State of shock, severe hypotension. - In combination with sildenafil, taladafil, vardenafil, avanafil and riociguat. - Obstructive cardiomyopathy. - Lower site myocardial infarction with extension to the right ventricle, in the acute phase, except in cases of signs of left ventricular failure. - Intracranial hypertension.\n- Contraindication to BOSENTAN VIATRIS 62.5 mg and 125 mg, film-coated tablet: - Hypersensitivity to the active substance or to one of the excipients mentioned in the SmPC. - Moderate to severe hepatic impairment corresponding to class B or C of the Child-Pugh classification. - Serum levels of hepatic aminotransferases, AST and/or ALT > 3 times the upper limit of normal at the start of treatment (results less than 3 months old). - Association with cyclosporin A.\n- Known allergy or intolerance to cellulose.\n- Patients treated with: tacrolimus or sirolimus, ciclosporin, fluconazole or other CYP2C9 or CYP3A4 inhibitors (ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, clarithromycin, erythromycin, telithromycin), glibenclamide, antiretroviral drugs including lopinavir + ritonavir, warfarin, simvastatin, enol , sildenafil, digoxin, rifampin, carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone.\n- Premenopausal woman whose contraception is contraception other than a copper intrauterine device.\n- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, guardianship or curatorship.\n- Patient participating or having participated in the 4 weeks preceding inclusion in a clinical trial.\n- Patients with arterial hypertension greater than or equal to 180/110 mmHg associated with symptoms suggesting the diagnosis of malignant hypertension.\n- Chronic renal failure stages 4 and 5 (defined by a CKD-EPI GFR < 30 ml/min/1.73m² less than 3 months old)\n- Renal transplant patient\n- Patient with a history of stroke, TIA, acute coronary syndrome or hospitalization for heart failure in the 3 to 6 months preceding the inclusion visit.\n- Patient with chronic heart failure NYHA III-IV.\n- Early initiation of treatment with hematopoietic growth factors (HCF)\n- Patient with a confirmed potassium level < 3.5 mEq/L or > 5.5 mEq/L\n- Patient with viral liver disease"}

Primary endpoints

• {"endpoint_text":"- 8-week change in amplitude of endothelium-dependent radial artery dilatation with sustained increase in blood flow","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 8 week change in peripheral and central arterial pressures and arterial stiffness","definition_or_measurement_approach":""}
• {"endpoint_text":"- 8-week change in local concentrations of NO, EETs and ET-1 with sustained increase in blood flow","definition_or_measurement_approach":""}
• {"endpoint_text":"- Variation in 8 weeks of natriuresis and measured glomerular filtration rate (DTPA labeled by the technetium 99m)","definition_or_measurement_approach":"Measured glomerular filtration rate using DTPA labeled by technetium 99m; natriuresis measurement as stated in endpoint"}

France

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

639

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France