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Modulation of Cerebral Blood Flow Using Iron Chelators (DFO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Farzaneh Sorond, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01365104
First received: May 31, 2011
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Stroke
Problem of Aging
 Drug: desferrioxamine
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypoxia-Inducible Transcription Factor 1 (HIF-1)in Vascular Aging

Resource links provided by NLM:

MedlinePlus related topics: Iron
U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Define change from baseline cerebral blood flow after receiving DFO infusion. [ Time Frame: baseline, 3hr, 6hr, 9hr ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 105
Study Start Date: March 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Farzaneh Sorond, Principle Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01365104     History of Changes
Other Study ID Numbers: 1K23AG030967-01, 1K23AG030967-01A1
Study First Received: May 31, 2011
Last Updated: February 14, 2013
Health Authority: United States: Data Safety Monitoring Board/NIA

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

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Deferoxamine
Siderophores
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013