Endothelin-1 Receptor Blockade in Resistant Hypertension
ConditionResistant Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Rouen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
age between 30 and 80 years old
Patients with resistant 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 under triple antihypertensive therapy at optimal dose comprising at least one diuretic pendant at less than 4 weeks.
Patients with resistant hypertension confirmed by self-measurement (≥135 / 85 mmHg on average) or by ambulatory blood pressure measurement (mean of 24h ≥130 / 80 mmHg).
Hemoglobin level ≥ 12 g / dL
Disqualifiers
Patients with hypertension
Patients with secondary arterial hypertension other than sleep apnea syndrome or chronic renal failure stage 2 or 3.
Patients with hypertension greater than or equal to 180 and / or 110mmHg
Chronic renal failure stage 4 and 5 (defined by DFG CKD-EPI <30 ml / min / 1,73m²)
Trial design
Design model
Parallel
Treatments tested in this trial
Bosentan
Drugvascular assesment Clinical exam urinary analysis blood results natriuresis and measured glomerular filtration rate
Placebo
DrugPlacebo
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: BosentanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
assess the effect of ET-1 receptor antagonist administration during 8 weeks on endothelial function in patients with resistant hypertension.
8-week change in amplitude of endothelium-dependent radial artery dilatation with sustained increase in blood flow
Time frame
through study completion, an average of 22 monthsSecondary outcomes
1
assess the effect of the administration of an ET-1 receptor antagonist during 8 weeks on systemic and central hemodynamics
8 week change in peripheral and central arterial pressures and arterial stiffness
Time frame
through study completion, an average of 22 months2
assess the effect of the administration of an ET-1 receptor antagonist during 8 weeks on local concentrations of endothelial factors during a sustained increase of the blood flow
8-week change in local concentrations of NO, EETs and ET-1 with sustained increase in blood flow
Time frame
through study completion, an average of 22 months3
assess the effect of the administration of an ET-1 receptor antagonist during 8 weeks on the renal function of patients with resistant hypertension.
Variation in 8 weeks of natriuresis and measured glomerular filtration rate (DTPA labeled by the technetium 99m)
Time frame
through study completion, an average of 22 monthsSponsors and contacts
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Source ClinicalTrials.gov