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

Medical University of Vienna

Status: Completed

Conditions: Regional Blood Flow; Ocular Physiology

Treatments: Drug: Nifedipine (drug); Drug: Placebo; Drug: L-Arginin (drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT00280462

OPHT-110705

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Male

Ages: 19 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Nifedipine

Treatment:

Drug: Nifedipine (drug)

Drug: Placebo

Drug: L-Arginin (drug)

2

Active Comparator group

Description:

L-Arginin

Treatment:

Drug: Nifedipine (drug)

Drug: Placebo

Drug: L-Arginin (drug)

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Nifedipine (drug)

Drug: Placebo

Drug: L-Arginin (drug)