NCT02062346

Brief Summary

Patients with vasculitis commonly develop cardiovascular disease. The reasons for this are not clear and is not adequately treated with current drugs. It is thus understand the reasons why patients with vasculitis develop cardiovascular disease in order to develop new drugs to reduced this risk. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
2.5 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.4 years

First QC Date

February 11, 2014

Last Update Submit

November 28, 2023

Conditions

Vasculitis

Keywords

endothelin;blood pressure;vasculitis

Outcome Measures

Primary Outcomes (2)

  • Study 1 - forearm blood flow

    Response to endothelium-dependent vasodilators

    20mins

  • Study 2 - pulse wave velocity

    Response of participants to ET antagonism

    4 hours

Secondary Outcomes (3)

  • Study 1 - tPA release

    20min

  • Study 1 - baseline pulse wave velocity

    Baseline

  • Study 2 - tPA release

    4 hours

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Saline placebo

Drug: Placebo

BQ123

EXPERIMENTAL

Intravenous infusion of BQ123 1000nmol/min for 15min

Drug: BQ123

BQ123/788

EXPERIMENTAL

Intravenous infusion of BQ123 1000nmol/min and BQ788 300nmol/min

Drug: BQ123/788

Assessment of forearm vascular function

NO INTERVENTION

Response of forearm blood flow to endothelium-dependent and endothelium-independent vasodilators

Interventions

BQ123DRUG

Intravenous infusion of BQ123 ( selective ETA antagonist )

Also known as: Selective ETA antagonism
BQ123
BQ123/788DRUG

or BQ123/788 (mixed ETA/B antagonists)

Also known as: mixed ETA/B antagonism
BQ123/788
PlaceboDRUG

Intravenous infusion of saline

Also known as: Saline
Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Age 18 years and over
  • Body mass index ≤35
  • Normal serum albumin

You may not qualify if:

  • Subject with diabetes or current smoking or chronic kidney disease (eGFR \<60ml/min)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Edinburgh

Edinburgh, Midlothian, EH16 4TJ, United Kingdom

Location

University of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35998848DERIVED

MeSH Terms

Conditions

Vasculitis

Interventions

cyclo(Trp-Asp-Pro-Val-Leu)Sodium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Neeraj Dhaun

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 13, 2014

Study Start

August 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

GB(2)