RecruitingPhase 2NCT04388124

Endothelin-1 Receptor Blockade in Resistant Hypertension

VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH RESISTANT ARTERIAL HYPERTENSION


Sponsor

University Hospital, Rouen

Enrollment

24 participants

Start Date

Oct 20, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests bosentan, a drug that blocks a blood vessel-constricting chemical called endothelin-1, to see if it can lower blood pressure in people with resistant hypertension — meaning their blood pressure remains high even when they are already taking three or more blood pressure medications. **You may be eligible if...** - You are between 30 and 80 years old - Your blood pressure remains at or above 140/90 mmHg despite taking three or more blood pressure medications (including at least one diuretic/water pill) at full doses - Your high blood pressure is confirmed by home monitoring or a 24-hour blood pressure monitor - Your hemoglobin level is 12 g/dL or above - Women of childbearing potential must use reliable contraception (not just hormonal methods alone during bosentan treatment) **You may NOT be eligible if...** - Your hypertension is caused by a secondary condition (other than sleep apnea or mild to moderate chronic kidney disease) - Your blood pressure is extremely high (180/110 mmHg or above) - You have severe chronic kidney disease (stage 4-5) or are on dialysis - You have had a kidney transplant - You have orthostatic hypotension (blood pressure drops significantly when you stand) - You are taking medications that interact with bosentan (such as certain antifungals, cyclosporine, or antiretroviral drugs) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBosentan

vascular assesment Clinical exam urinary analysis blood results natriuresis and measured glomerular filtration rate

DRUGPlacebo

Placebo


Locations(1)

Chu Rouen

Rouen, France

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NCT04388124


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