2024-515928-36-00尚未招募2 期
VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH UNCONTROLLED ARTERIAL HYPERTENSION - ENDOTHELIN-2
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 8-week change in amplitude of endothelium-dependent radial artery dilatation with sustained increase in blood flow
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
次要结局
- 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
- Variation in 8 weeks of natriuresis and measured glomerular filtration rate (DTPA labeled by the technetium 99m)
研究者
David MALLET
Scientific
Centre Hospitalier Universitaire Rouen
研究点 (1)
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