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

Condition(s) targeted: Ocular Physiology; Regional Blood Flow

Intervention: Nifedipine (drug) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Gabriele Fuchsjäger-Mayrl, M.D., Principal Investigator, Affiliation: Department of Clinical Pharmacology, Medical University of Vienna

Overall contact:
Gerhard Garhöfer, M.D., Phone: +43 1 40400 2981, Email: gerhard.garhoefer@meduniwien.ac.at

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Choroidal pressure-blood flow relationship

Minimum age: 19 Years. Maximum age: 35 Years. Gender(s): Male.

Criteria:

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

Gerhard Garhöfer, M.D., Phone: +43 1 40400 2981, Email: gerhard.garhoefer@meduniwien.ac.at

Department of Clinical Pharmacology, Vienna 1090, Austria; Recruiting

Starting date: July 2005
Last updated: January 19, 2006