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New treatment option for Resistant Hypertension
Official title Endothelin-1 Receptor Blockade in Resistant Hypertension
ClinicalTrials.gov ID: NCT04388124
What this study is testing
What is Bosentan?
Bosentan is an investigational medicine, being studied as a potential treatment for resistant hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Patients with resistant hypertension confirmed by self-measurement (≥135 / 85 mmHg on average) or by ambulatory blood pressure measurement (mean of...
- 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...
You likely can't join if
- 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).
See the full eligibility 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...
- 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.