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Choroidal Blood Flow Regulation During Isometric Exercise: Effects of Ca2+-Channel Blockade

Choroidal Blood Flow Regulation During Isometric Exercise: Effects of Ca2+-Channel Blockade

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00280462
Enrollment
21
Registered
2006-01-23
Start date
2005-08-31
Completion date
2006-04-30
Last updated
2008-07-09

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

Conditions

Ocular Physiology, Regional Blood Flow

Keywords

Nifedipine, Choroidal blood flow, Choroidal autoregulation, Isometric exercise

Brief summary

Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. For a long time it had been assumed that the choroid is a strictly passive vascular bed, which shows no autoregulation. However, recently several groups have identified some autoregulatory capacity of the human choroid. In the brain and the retina the mechanism behind autoregulation is most likely linked to changes in transmural pressure. In this model arterioles change their vascular tone depending on the pressure inside the vessel and outside the vessel. In the choroid, several observations argue against a direct involvement of arterioles. In a previous project we were able to identify that the nitric oxide (NO) - system as well as the endothelin system are involved in choroidal blood flow regulation during isometric exercise. In the present study autoregulation of the choroid during isometric exercise will be investigated and the pressure/flow relationships will be observed in the absence or presence of a calcium antagonist - nifedipine.

Interventions

DRUGNifedipine (drug)

Nifedipine (Adalat®, Bayer, Leverkusen, Germany) dose: 15µg/kg bolus infusion over 5 minutes; 0.2 µg/(kg.min) maintenance dose infusion period 25 minutes

DRUGL-Arginin (drug)

L-Arginin (Clinalfa AG, Läufelfingen, Switzerland) 30% sodium chlorid solution, dose: 1g/min over 30 minutes

DRUGPlacebo

Placebo

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
19 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Men aged between 19 and 35 years, nonsmokers * Body mass index between 15th and 85th percentile (Must et al. 1991) * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * Normal ophthalmic findings, ametropy more than 3 Dpt.

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 * Symptoms of a clinically relevant illness in the 3 weeks before the first study day * History of hypersensitivity to the trial drug or to drugs with a similar chemical structure * 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

Design outcomes

Primary

MeasureTime frame
Choroidal pressure-blood flow relationshipin total 3x 3 hours

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026