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Role of Endothelin-1 in Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Healthy Humans

Role of Endothelin-1 in Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Healthy Humans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00915070
Enrollment
16
Registered
2009-06-05
Start date
2010-10-31
Completion date
2011-12-31
Last updated
2012-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

BQ-123, Optic Nerve Head Blood Flow, Intraocular Pressure, Regional Blood Flow, Ocular Physiology, Optic Disk

Brief summary

Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. The investigators could recently show that Endothelin-1 is a key metabolite in the regulation of vascular tone in the eye and plays an important role in the blood flow autoregulation of the choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the present study is designed to test the hypothesis that Endothelin-1 plays also a role in optic nerve head blood flow autoregulation. Therefore, subjects will perform squatting to increase systemic perfusion pressure during administration of either an endothelin A-receptor blocker (BQ-123) or placebo. Optic nerve head blood flow will be continuously measured during the procedure to investigate optic nerve head autoregulation.

Interventions

DRUGBQ-123

60 mcg/min, infusion period: 60 min

infusion period 60 minutes

blood flow measurements at the temporal neuroretinal rim to assess optic nerve head blood flow

intraocular pressure measurements

subjects will perform squatting for 6 minutes while blood flow measurements

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Men and women aged between 18 and 35 years, nonsmokers * Men and women will be included in equal parts * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant * Normal ophthalmic findings, ametropia less than 3 diopters

Exclusion criteria

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * Treatment in the previous 3 weeks with any drug (except intake of oral contraceptives) * Symptoms of a clinically relevant illness in the 3 weeks before the first study day * History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs * Blood donation during the previous 3 weeks * Pregnancy

Design outcomes

Primary

MeasureTime frame
Optic nerve head pressure-flow relationship1 year

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026