Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
64 participants
INTERVENTIONAL
2016-08-31
2020-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Endothelin is a chemical produced by blood vessels that contributes to the development of hypertension and cardiovascular disease Higher than normal levels of endothelin are seen in patients with vasculitis but how this contributes to cardiovascular disease in patients with vasculitis is not clear. By using drugs that block the effects of endothelin ('endothelin receptor antagonists') the investigators can hopefully reduce the risk of cardiovascular disease in patients with vasculitis. The purpose of the study is to ascertain if endothelin receptor antagonists improve blood vessel function in patients with vasculitis.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study 1 Both patients and control will attend for visit 1: assessment of vascular function using forearm plethysmography as part of case control study.
Vasculitis patients will then attend for visits 2, 3 \& 4 as part of randomised three way crossover study (randomised \& infusions given in a double-blind method): comparison of the effects of selective ETA receptor antagonism (BQ123; 1000nmol/min for 15min iv), mixed ETA/B antagonism (BQ123/788; 1000 nmol/min \& 300 nmol/min for 15 min), and placebo on systemic haemodynamics.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Saline placebo
Placebo
Intravenous infusion of saline
BQ123
Intravenous infusion of BQ123 1000nmol/min for 15min
BQ123
Intravenous infusion of BQ123 ( selective ETA antagonist )
BQ123/788
Intravenous infusion of BQ123 1000nmol/min and BQ788 300nmol/min
BQ123/788
or BQ123/788 (mixed ETA/B antagonists)
Assessment of forearm vascular function
Response of forearm blood flow to endothelium-dependent and endothelium-independent vasodilators
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BQ123
Intravenous infusion of BQ123 ( selective ETA antagonist )
BQ123/788
or BQ123/788 (mixed ETA/B antagonists)
Placebo
Intravenous infusion of saline
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 18 years and over
* Body mass index ≤35
* Normal serum albumin
Exclusion Criteria
* Subject with pre-existing cardiovascular disease
* Subject is below the age of legal consent, or is mentally or legally incapacitated
* History of multiple and/or severe allergic reactions to drugs (including study drugs)
* The subject has donated blood (450 ml) within the last 4 weeks
* Past or present drug or alcohol abuse including intravenous drug abuse at any time
* Participation in another clinical trial within 1 month
* Considered to be at high risk of HIV or hepatitis B
* Women of child-bearing potential (only women who are post-menopausal or surgically-sterilised will be included in the study)
18 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
British Heart Foundation
OTHER
University of Edinburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neeraj Dhaun
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Edinburgh
Edinburgh, Midlothian, United Kingdom
University of Edinburgh
Edinburgh, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Farrah TE, Melville V, Czopek A, Fok H, Bruce L, Mills NL, Bailey MA, Webb DJ, Dear JW, Dhaun N. Arterial stiffness, endothelial dysfunction and impaired fibrinolysis are pathogenic mechanisms contributing to cardiovascular risk in ANCA-associated vasculitis. Kidney Int. 2022 Nov;102(5):1115-1126. doi: 10.1016/j.kint.2022.07.026. Epub 2022 Aug 20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Bean ICRF clinical study
Identifier Type: -
Identifier Source: org_study_id