NCT04388124 Endothelin-1 Receptor Blockade in Resistant Hypertension
| NCT ID | NCT04388124 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Rouen |
| Condition | Resistant Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2021-10-20 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2021-10-20 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 * For women of childbearing potential, reliable methods of contraception (as defined by the WHO-Pearl Index) should be used (hormonal contraception should not be the only contraceptive method used during bosentan treatment). * For postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months and age greater than 45, before the inclusion visit) * Patient who read and understood the newsletter and signed the consent form * Patient affiliated to a social security scheme Exclusion Criteria: * 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) * Renal transplant patient XML File Identifier: CEyMau8sPo+QFyOLD1ZEY3ZGFow= Page 11/22 * Orthostatic hypotension (decreased SBP\> 20mmHg and / or DBP\> 10mmHg occurring within 3 minutes of standing). * Contra-indication to NATISPRAY 0.30 mg / dose, oral spray solution (including nitrate hypersensitivity) in accordance with the NATISPRAY SPC: * shock, severe hypotension, * in combination with sildenafil * obstructive cardiomyopathy, * inferior court inferior myocardial infarction with right ventricular extension, except in case of evidence of left ventricular failure, * intracranial hypertension, • Contra-indication to BOSENTAN MYLAN 62.5 mg and 125 mg filmcoated tablets: * Hypersensitivity to the active substance or to any of the excipients listed in the SPC Moderate to severe hepatic insufficiency corresponding to class B or C of the Child-Pugh classification * Serum levels of liver aminotransferases, ASAT and / or ALAT\> 3 times the upper limit of normal at start of treatment (results less than 3 months old). * Association with ciclosporin A * Known allergy to cellulose * Patients treated with: tacrolimus or sirolimus, fluconazole or other CYP2C9 or CYP3A4 inhibitors, glibenclamide, rifampicin, antiretroviral drugs including lopinavir + ritonavir, warfarin, simvastatin, ketoconazole, epoprostenol, sildenafil and digoxin * Pregnant, breastfeeding woman, or woman of childbearing potential not using reliable methods of contraception (hormonal contraception should not be the only contraceptive method used during bosentan treatment) or no proven reliable effective contraception; * Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice, under tutorship or curatorship * Patient participating or having participated in the 4 weeks prior to inclusion in a clinical trial
Frequently Asked Questions
Who can join the NCT04388124 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Resistant Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04388124 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04388124 currently recruiting?
Yes, NCT04388124 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Rouen to inquire about joining.
Where is the NCT04388124 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT04388124 clinical trial?
NCT04388124 is sponsored by University Hospital, Rouen. The trial plans to enroll 24 participants.