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DFO: Modulation of Cerebral Blood Flow Using Iron Chelators

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01365104
Collaborator
National Institute on Aging (NIA) (NIH)
97
Enrollment
1
Location
2
Arms
81
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
Early Phase 1

Study Design

Study Type:
Interventional
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 :
Mar 1, 2008
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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 Names:
  • 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 Names:
  • Desferal, desferoxamine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Define change from baseline cerebral blood flow after receiving DFO infusion. [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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Farzaneh Sorond, Principle Investigator, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT01365104
    Other Study ID Numbers:
    • 1K23AG030967-01
    • 1K23AG030967-01A1
    First Posted:
    Jun 3, 2011
    Last Update Posted:
    Jan 28, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Farzaneh Sorond, Principle Investigator, Brigham and Women's Hospital
    brain blood flow
    stroke
    cerebrovascular
    aging
    cerebrovascular hemodynamics
    Additional relevant MeSH terms:
    Stroke
    Deferoxamine

    Study Results

    No Results Posted as of Jan 28, 2015