VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH UNCONTROLLED ARTERIAL HYPERTENSION - ENDOTHELIN-2
- Conditions
- Uncontrolled arterial hypertension
- Registration Number
- 2024-515928-36-00
- Lead Sponsor
- Centre Hospitalier Universitaire Rouen
- Brief Summary
The main objective of the study is to assess the effect of ET-1 receptor antagonist administration during 8 weeks on endothelial function in patients with uncontrolled hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 24
age between 30 and 80 years old
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.
Patients with uncontrolled hypertension confirmed by selfmeasurement (≥135 / 85 mmHg on average) or by ambulatory blood pressure measurement (mean of 24h ≥130 / 80 mmHg).
Hemoglobin level > 11 g / dL
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).
For postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months and age greater than 45, before the inclusion visit)
Patient who read and understood the newsletter and signed the consent form
Patient affiliated to a social security scheme
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.
Patient with unbalanced diabetes (HbA1c >7.5%)
Patient with proteinuria > 1g/g creatininuria
Orthostatic hypotension (decrease in SBP > 20mmHg and/or DBP >10 mmHg occurring within 3 minutes following standing).
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.
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.
Known allergy or intolerance to cellulose.
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.
Premenopausal woman whose contraception is contraception other than a copper intrauterine device.
Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, guardianship or curatorship.
Patient participating or having participated in the 4 weeks preceding inclusion in a clinical trial.
Patients with arterial hypertension greater than or equal to 180/110 mmHg associated with symptoms suggesting the diagnosis of malignant hypertension.
Chronic renal failure stages 4 and 5 (defined by a CKD-EPI GFR < 30 ml/min/1.73m² less than 3 months old)
Renal transplant patient
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.
Patient with chronic heart failure NYHA III-IV.
Early initiation of treatment with hematopoietic growth factors (HCF)
Patient with a confirmed potassium level < 3.5 mEq/L or > 5.5 mEq/L
Patient with viral liver disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 8-week change in amplitude of endothelium-dependent radial artery dilatation with sustained increase in blood flow 8-week change in amplitude of endothelium-dependent radial artery dilatation with sustained increase in blood flow
- Secondary Outcome Measures
Name Time Method 8 week change in peripheral and central arterial pressures and arterial stiffness 8 week change in peripheral and central arterial pressures and arterial stiffness
8-week change in local concentrations of NO, EETs and ET-1 with sustained increase in blood flow 8-week change in local concentrations of NO, EETs and ET-1 with sustained increase in blood flow
Variation in 8 weeks of natriuresis and measured glomerular filtration rate (DTPA labeled by the technetium 99m) Variation in 8 weeks of natriuresis and measured glomerular filtration rate (DTPA labeled by the technetium 99m)
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire Rouen
🇫🇷Rouen Cedex, France
Centre Hospitalier Universitaire Rouen🇫🇷Rouen Cedex, FranceLudivine LEBOURGSite contact+33232889002Ludivine.Lebourg@chu-rouen.fr