Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT04388124

Endothelin-1 Receptor Blockade in Resistant Hypertension

Led by University Hospital, Rouen · Updated on 2026-02-17

24

Participants Needed

1

Research Sites

249 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The management of patients with resistant arterial hypertension, who are characterized by a very high cardiovascular risk, remains a major therapeutic issue. The use of endothelin-1 (ET-1) receptor antagonists, in addition to lowering blood pressure, may also improve endothelial function in these patients. The objective of this study is to assess the vascular impact of an ET-1 receptor antagonist on vascular function and systemic and central hemodynamics in patients with resistant arterial hypertension and ensure their good renal tolerance.

CONDITIONS

Official Title

Endothelin-1 Receptor Blockade in Resistant Hypertension

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 30 and 80 years old
  • Resistant hypertension with blood pressure ≥140/90 mmHg despite triple antihypertensive therapy including at least one diuretic for less than 4 weeks
  • Resistant hypertension confirmed by self-measurement (≥135/85 mmHg) or ambulatory blood pressure measurement (mean 24h ≥130/80 mmHg)
  • Hemoglobin level ≥12 g/dL
  • For women of childbearing potential, use of reliable contraception methods (hormonal contraception alone not allowed during bosentan treatment)
  • For postmenopausal women, diagnosis confirmed by non-medically induced amenorrhea for at least 12 months and age over 45
  • Ability to read, understand the information leaflet, and sign consent form
  • Affiliation to a social security scheme
Not Eligible

You will not qualify if you...

  • Secondary arterial hypertension other than sleep apnea syndrome or chronic renal failure stage 2 or 3
  • Blood pressure ≥180/110 mmHg
  • Chronic renal failure stage 4 or 5 (glomerular filtration rate <30 ml/min/1.73m²)
  • Renal transplant patient
  • Orthostatic hypotension causing a drop in systolic blood pressure >20 mmHg or diastolic >10 mmHg within 3 minutes of standing
  • Contraindications to NATISPRAY 0.30 mg oral spray (including nitrate hypersensitivity), such as shock, severe hypotension, combination with sildenafil, obstructive cardiomyopathy, recent right ventricular infarction without left ventricular failure, intracranial hypertension
  • Contraindications to BOSENTAN MYLAN tablets including hypersensitivity, moderate to severe liver insufficiency (Child-Pugh class B or C), liver enzyme levels >3 times normal
  • Use of ciclosporin A or certain other medications like tacrolimus, sirolimus, fluconazole, CYP2C9 or CYP3A4 inhibitors, glibenclamide, rifampicin, certain antiretroviral drugs, warfarin, simvastatin, ketoconazole, epoprostenol, sildenafil, digoxin
  • Allergy to cellulose
  • Pregnant, breastfeeding, or women of childbearing potential not using reliable contraception
  • Persons deprived of liberty or under legal protection such as guardianship
  • Participation in another clinical trial within 4 weeks prior to inclusion

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Chu Rouen

Rouen, France, 76031

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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