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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00280462
First received: January 19, 2006
Last updated: July 8, 2008
Last verified: July 2008

January 19, 2006
July 8, 2008
August 2005
April 2006   (final data collection date for primary outcome measure)
Choroidal pressure-blood flow relationship [ Time Frame: in total 3x 3 hours ] [ Designated as safety issue: No ]
Choroidal pressure-blood flow relationship
Complete list of historical versions of study NCT00280462 on ClinicalTrials.gov Archive Site
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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

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Ocular Physiology
  • Regional Blood Flow
  • Drug: Nifedipine (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
  • Drug: L-Arginin (drug)
    L-Arginin (Clinalfa AG, Läufelfingen, Switzerland) 30% sodium chlorid solution, dose: 1g/min over 30 minutes
  • Drug: Placebo
    Placebo
  • Active Comparator: 1
    Nifedipine
    Interventions:
    • Drug: Nifedipine (drug)
    • Drug: L-Arginin (drug)
    • Drug: Placebo
  • Active Comparator: 2
    L-Arginin
    Interventions:
    • Drug: Nifedipine (drug)
    • Drug: L-Arginin (drug)
    • Drug: Placebo
  • Placebo Comparator: 3
    Placebo
    Interventions:
    • Drug: Nifedipine (drug)
    • Drug: L-Arginin (drug)
    • Drug: Placebo
Schmidl D, Prinz A, Kolodjaschna J, Polska E, Luksch A, Fuchsjager-Mayrl G, Garhofer G, Schmetterer L. Effect of nifedipine on choroidal blood flow regulation during isometric exercise. Invest Ophthalmol Vis Sci. 2012 Jan 25;53(1):374-8. Print 2012 Jan.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Male
19 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00280462
OPHT-110705
Yes
Gabriele Fuchsjaeger-Mayrl, MD, Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Gabriele Fuchsjäger-Mayrl, M.D. Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP