Study of Bosentan to Improve Vascular and Kidney Function in Adults with Resistant Hypertension

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.

Endothelin-1 Receptor Blockade in Resistant Hypertension