Modulation of Cerebral Blood Flow Using Iron Chelators

Stroke Clinical Trial

— DFO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365104
• Other study ID #: 1K23AG030967-01
• Secondary ID: 1K23AG030967-01A
• Status: Completed
• Phase: Phase 0
• First received: May 31, 2011
• Last updated: January 26, 2015
• Start date: March 2008
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data Safety Monitoring Board/NIA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Problem of Aging
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define change from baseline cerebral blood flow after receiving DFO infusion.	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.	baseline, 3hr, 6hr, 9hr	No
Primary	Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics.	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.	baseline, 3hr, 6hr, 9hr	No