Actively Recruiting
Vascular and Renal Impact of Endothelin-1 Receptor Blockade in Patients with Resistant Arterial Hypertension
Led by University Hospital, Rouen · Updated on 2026-02-17
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with resistant arterial hypertension, a condition marked by high blood pressure that remains difficult to control and carries a very high risk for heart and blood vessel problems. This study aims to evaluate the effects of blocking endothelin-1 (ET-1) receptors, which may not only lower blood pressure but also improve the function of blood vessels and protect kidney health. This is a phase 2 clinical trial sponsored by the University Hospital in Rouen. Participants will be randomly assigned to receive either Bosentan, an ET-1 receptor antagonist, or a placebo. Both groups will take capsules twice daily, starting with 2 capsules of 62.5 mg per day for about 27 days, followed by 2 capsules of 125 mg per day for another 27 days, totaling 56 days of treatment. The study uses a double-blind design, meaning neither the participants nor the researchers know who receives Bosentan or placebo during the trial. During the trial, participants will undergo various assessments including clinical exams, urine and blood tests, and measurements of kidney function and blood vessel health. Researchers will monitor changes in endothelial function, systemic and central blood flow, and kidney performance over about 8 weeks of treatment, with follow-up averaging 22 months. The study also tracks safety and tolerability to ensure the treatment does not harm kidney function.
CONDITIONS
Brief Title
Endothelin-1 Receptor Blockade in Resistant Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 80 years old
- Diagnosed with resistant hypertension defined by 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 (average ≥ 135/85 mmHg) or ambulatory blood pressure measurement (mean 24h ≥ 130/80 mmHg)
- Hemoglobin level ≥ 12 g/dL
- Women of childbearing potential must use reliable contraception methods during Bosentan treatment
- Postmenopausal women must have non-medically induced amenorrhea for at least 12 months and be older than 45 years
- Able to read and understand the newsletter and provide signed informed consent
- Affiliated to a social security scheme
You will not qualify if you...
- Patients with hypertension greater than or equal to 180 and/or 110 mmHg
- Patients with secondary arterial hypertension except sleep apnea syndrome or chronic renal failure stage 2 or 3
- Chronic renal failure stage 4 and 5 (glomerular filtration rate < 30 ml/min/1.73m²)
- Renal transplant recipients
- Orthostatic hypotension (drop in systolic BP > 20 mmHg or diastolic BP > 10 mmHg within 3 minutes of standing)
- Contraindications to Natispray oral spray solution including nitrate hypersensitivity, shock, severe hypotension, combination with sildenafil, obstructive cardiomyopathy, recent inferior myocardial infarction with right ventricular extension unless left ventricular failure is present, intracranial hypertension
- Contraindications to Bosentan including hypersensitivity, moderate to severe hepatic insufficiency (Child-Pugh class B or C), liver enzyme levels > 3 times normal at treatment start
- Use of ciclosporin A
- Known allergy to cellulose
- Use of medications including tacrolimus, sirolimus, fluconazole, CYP2C9 or CYP3A4 inhibitors, glibenclamide, rifampicin, certain antiretrovirals, warfarin, simvastatin, ketoconazole, epoprostenol, sildenafil, digoxin
- Pregnant, breastfeeding, or women of childbearing potential not using reliable contraception
- Persons deprived of liberty or under legal protection such as tutorship or curatorship
- Participation in another clinical trial within 4 weeks prior to inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 56 days
Participants receive either Bosentan or placebo to assess the effects on endothelial function and blood pressure.
Regular visits during the 8-week treatment period
Trial Site Locations
Total: 1 location
1
Chu Rouen
Rouen, France, 76031
Actively Recruiting
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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