Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Modulation of Cerebral Blood Flow Using Iron Chelators (DFO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Farzaneh Sorond, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01365104
First received: May 31, 2011
Last updated: January 17, 2014
Last verified: January 2014

May 31, 2011
January 17, 2014
March 2008
June 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01365104 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Modulation of Cerebral Blood Flow Using Iron Chelators
Hypoxia-Inducible Transcription Factor 1 (HIF-1)in Vascular Aging

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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Stroke
  • Problem of Aging
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 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.
    Intervention: Drug: desferrioxamine
  • 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.
    Intervention: Drug: desferrioxamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
105
July 2014
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01365104
1K23AG030967-01, 1K23AG030967-01A1
Yes
Farzaneh Sorond, Brigham and Women's Hospital
Brigham and Women's Hospital
National Institute on Aging (NIA)
Principal Investigator: Farzaneh Sorond, MD, PhD Brigham and Women's Hospital
Brigham and Women's Hospital
January 2014

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