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Modulation of Cerebral Blood Flow Using Iron Chelators (DFO)

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ClinicalTrials.gov Identifier: NCT01365104
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : January 28, 2015
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Farzaneh Sorond, Brigham and Women's Hospital

Brief Summary:
The purpose of this study is determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.

Condition or disease Intervention/treatment Phase
Stroke Problem of Aging Drug: desferrioxamine Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypoxia-Inducible Transcription Factor 1 (HIF-1)in Vascular Aging
Study Start Date : March 2008
Primary Completion Date : June 2012
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Healthy young
Each subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other.
Drug: desferrioxamine
intravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg.
Other Name: Desferal, desferoxamine
Experimental: healthy old
Each subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other.
Drug: desferrioxamine
intravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg.
Other Name: Desferal, desferoxamine



Primary Outcome Measures :
  1. Define change from baseline cerebral blood flow after receiving DFO infusion. [ Time Frame: baseline, 3hr, 6hr, 9hr ]
    Cerebral blood flow is measured with transcranial Doppler ultrasound at baseline and then study drug is initiated. Blood flow is measured again after 3 hours of infusion, 6 hours of infusion, then once more 3 hours after the infusion is complete.

  2. Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics. [ Time Frame: baseline, 3hr, 6hr, 9hr ]
    Blood samples are taken at each time point and will be correlated with ultrasound blood flow measures taken at baseline, 3hrs of infusion, 6hrs of infusion, and 3 hours after infusion is complete.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adults between the ages of 18-80 years.

Exclusion Criteria:

  • subjects taking vasoactive medications,
  • hypertension,
  • pregnant women, smokers,
  • COPD,
  • asthma,
  • diabetes mellitus,
  • intracranial or carotid stenosis,
  • hepatic disease,
  • renal disease,
  • bone marrow suppression,
  • cardiac disease,
  • heart failure,
  • iron deficiency,
  • history of cancer,
  • history of head trauma,
  • subarachnoid hemorrhage,
  • central nervous system vasculitis,
  • multiple sclerosis,
  • migraines,
  • seizures,
  • sickle cell disease or trait,
  • cardiac arrhythmia,
  • unable to give informed consent, or
  • poor transcranial Doppler insonation windows.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365104


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute on Aging (NIA)
Investigators
Principal Investigator: Farzaneh Sorond, MD, PhD Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Farzaneh Sorond, Principle Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01365104     History of Changes
Other Study ID Numbers: 1K23AG030967-01 ( U.S. NIH Grant/Contract )
1K23AG030967-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015

Keywords provided by Farzaneh Sorond, Brigham and Women's Hospital:
brain blood flow
stroke
cerebrovascular
aging
cerebrovascular hemodynamics

Additional relevant MeSH terms:
Deferoxamine
Siderophores
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action