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Modulation of Cerebral Blood Flow Using Iron Chelators

Hypoxia-Inducible Transcription Factor 1 (HIF-1)in Vascular Aging

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01365104
Acronym
DFO
Enrollment
97
Registered
2011-06-03
Start date
2008-03-31
Completion date
2014-12-31
Last updated
2015-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Problem of Aging, Stroke

Keywords

brain blood flow, stroke, cerebrovascular, aging, cerebrovascular hemodynamics

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.

Interventions

intravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Define change from baseline cerebral blood flow after receiving DFO infusion.baseline, 3hr, 6hr, 9hrCerebral 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.baseline, 3hr, 6hr, 9hrBlood 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026