Healthy ConditionsEndothelinNCT02086253
Role of Endothelin-1 in Flow-mediated Dilatation
A study testing BQ-788 and/or BQ-123 in people with Healthy Conditions, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Conditions
- What is being tested?
- BQ-788 and/or BQ-123
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Endothelin-1 in Mediating Flow-mediated Dilatation of Conduit Arteries During Sustained Hyperemic Stimulation
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.
- Conditions
- Healthy Conditions
- Being tested
- BQ-788 and/or BQ-123
- Keywords
- Endothelin, endothelium, flow-mediated dilatation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BQ-788 and/or BQ-123Drug
| Study group | Role | What they receive |
|---|---|---|
| BQ-788 | Experimental | Effect of BQ-788 on the magnitude of sustained flow-mediated dilatation Receives: Drug: BQ-788 and/or BQ-123 |
| BQ-123 | Experimental | Effect of BQ-123 on the magnitude of sustained flow-mediated dilatation Receives: Drug: BQ-788 and/or BQ-123 |
| BQ-788 + BQ-123 | Experimental | Effect of BQ-788+BQ-123 on the magnitude of sustained flow-mediated dilatation Receives: Drug: BQ-788 and/or BQ-123 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ETB receptor blockade on flow-mediated dilatation
This study will evaluate the effect of the ETB receptor blockade on the magnitude of the flow-mediated dilatation of the radial artery in response to distal skin heating in 8 healthy subjects. Radial artery diameter and blood flow will be measured by high-resolution echotracking coupled to Doppler.
Measured: One hour after BQ-788 brachial infusion
Secondary outcomes (2)
Effect of ETA and ETA/ETB receptor blockade on flow-mediated dilatation
This study will evaluate the effect of ETA receptor and combined ETA/ETB receptor blockade on the magnitude of the flow-mediated dilatation of the radial artery in response to distal skin heating in 8 healthy subjects. Radial artery diameter and blood flow will be measured by high-resolution echotracking coupled to Doppler.
Measured: One hour after BQ-123 alone or with BQ-788 brachial infusion
Effect of ETA and/or ETB receptor blockade on ET-1, NO and EET bioavailability
This study will evaluate the effect of ETA and/or ETB blockade on the variations in the local concentrations of ET-1, NO and EETs during sustained flow-mediated dilation in 8 healthy subjects. For this purpose, local blood samples will be drawn before (34°C) and at the end of hand skin heating (44°C). Plasma nitrite, indicator of NO availability will be quantified by chemiluminescence.Plasma EETs will be quantified by LC-MS. Plasma ET-1 will be quantified with an immunoassay.
Measured: One hour after BQ-788 and/or BQ-123 brachial infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ConditionsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robinson JOANNIDES, Doctor, Principal investigator, Chu - Hôpitaux de Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086253
- Sponsor's protocol ID
- 2013/161/HP
- Other IDs
- 2013-004425-87
- Acronym
- Endothelin
- Status last verified
- Mar 2015
- First submitted
- 18 Feb 2014
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellien J, Iacob M, Monteil C, Remy-Jouet I, Roche C, Duflot T, Vendeville C, Gutierrez L, Thuillez C, Richard V, Joannides R. Physiological role of endothelin-1 in flow-mediated vasodilatation in humans and impact of cardiovascular risk factors. J Hypertens. 2017 Jun;35(6):1204-1212. doi: 10.1097/HJH.0000000000001307.
PubMed 28441692
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endothelin-1 in Mediating Flow-mediated Dilatation of Conduit Arteries During Sustained Hyperemic Stimulation
- ClinicalTrials.gov ID
- NCT02086253
- Acronym / sponsor ID
- Endothelin / 2013/161/HP
- Conditions
- Healthy Conditions
- Keywords
- Endothelin, endothelium, flow-mediated dilatation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BQ-788 | Experimental | Drug: BQ-788 and/or BQ-123Effect of BQ-788 on the magnitude of sustained flow-mediated dilatation |
| BQ-123 | Experimental | Drug: BQ-788 and/or BQ-123Effect of BQ-123 on the magnitude of sustained flow-mediated dilatation |
| BQ-788 + BQ-123 | Experimental | Drug: BQ-788 and/or BQ-123Effect of BQ-788+BQ-123 on the magnitude of sustained flow-mediated dilatation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- Known allergy
- Intolerance to glyceryl trinitrate
- Intolerance to lidocaine
- Family history of hypertension
- Excessive alcohol consumption ( more than 50 g / day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BQ-788 and/or BQ-123 | Drug | BQ-123, BQ-788, BQ-788 + BQ-123 |
Primary outcome
Effect of ETB receptor blockade on flow-mediated dilatation
Time frame: One hour after BQ-788 brachial infusion
This study will evaluate the effect of the ETB receptor blockade on the magnitude of the flow-mediated dilatation of the radial artery in response to distal skin heating in 8 healthy subjects. Radial artery diameter and blood flow will be measured by high-resolution echotracking coupled to Doppler.
2 secondary outcomes
Effect of ETA and ETA/ETB receptor blockade on flow-mediated dilatation
Time frame: One hour after BQ-123 alone or with BQ-788 brachial infusion
Effect of ETA and/or ETB receptor blockade on ET-1, NO and EET bioavailability
Time frame: One hour after BQ-788 and/or BQ-123 brachial infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 28441692Bellien J, Iacob M, Monteil C, Remy-Jouet I, Roche C, Duflot T, Vendeville C, Gutierrez L, Thuillez C, Richard V, Joannides R. Physiological role of endothelin-1 in flow-mediated vasodilatation in humans and impact of cardiovascular risk factors. J Hypertens. 2017 Jun;35(6):1204-1212. doi: 10.1097/HJH.0000000000001307.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robinson JOANNIDES, Doctor principal investigator
Chu - Hôpitaux de Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BQ-788 and/or BQ-123 in people with Healthy Conditions, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of ETB receptor blockade on flow-mediated dilatation (time frame: One hour after BQ-788 brachial infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.