BridgeMD
VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH UNCONTROLLED ARTERIAL HYPERTENSION - ENDOTHELIN-2
EU CTIS ID: 2024-515928-36-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.