CompletedNot Applicable

Role of Endothelin-1 in Flow-mediated Dilatation

France8 participantsStarted 2014-02

Plain-language summary

Endothelial dysfunction of conduit arteries contributes to the increased morbidity and cardiovascular mortality in patients with essential hypertension and appears increasingly as an independent therapeutic target. We have shown previously that besides a decrease in the availability of NO and other endothelium-derived vasodilators factors, the epoxyeicosatrienoic acids, an increase in the vasoconstrictor endothelin-1 (ET-1) may play a role in the pathophysiology of this endothelial dysfunction. Indeed, the local concentrations of endothelin-1 during the endothelium-dependent dilation of the radial artery in response to a sustained increase in blood flow decreased significantly in healthy volunteers controls but not in hypertensive patients. This lack of adaptation of the endothelinergic system could be due to a decreased clearance of endothelin-1 by endothelial ETB receptors, potentiating the vasoconstrictor action of endothelin-1 mediated by ETA receptor activation at the muscular level. However, to validate this hypothesis , it is needed to demonstrate the physiological role of ETA receptor and ETB in sustained flow-mediated dilatation of conduit arteries.

Who can participate

Age range

18 Years – 35 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male, Caucasian, aged 18 to 35 years * Non-Smoking * Resting heart rate\> 50 and \<90 bpm * SBP \<140 mmHg and DBP \<90 mm Hg at rest in the supine position for 10 minutes * Normal ECG Exclusion Criteria: * Known allergy * Intolerance to glyceryl trinitrate * Intolerance to lidocaine * Family history of hypertension * Excessive alcohol consumption ( more than 50 g / day) * Addiction or presumption of illicit drug use * Subject refusing blood samples for serology of hepatitis B , C and HIV * History of illness or psychological or sensory abnormality that may prevent the subject to understand the requirements for participation in the protocol or prevents giving informed consent * Metabolic or endocrine disease * Immunological diseases * Renal or hepatic impairment * Ischemic or obstructive heart disease * Neoplastic disease * Gastrointestinal disease * Neurological disease , intracranial hypertension , seizure disorders * Compulsive overeating , bulimia, anorexia * Severe psychiatric illness * Presence of a clinically significant abnormality in laboratory tests carried out at the inclusion visit . * HBs Ag , HCV Ab , Ac HIV 1 or HIV 2 positive . * The use of any drug in the range of less than 5 half-life time, in particular betablockers, sildenafil, cimetidine, amiodarone .

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect of ETB receptor blockade on flow-mediated dilatation

Timeframe: One hour after BQ-788 brachial infusion

Trial details

NCT IDNCT02086253

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-05

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