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Modulation of Cerebral Blood Flow Using Iron Chelators (DFO)

Primary Purpose

Stroke, Problem of Aging

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
desferrioxamine
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring brain blood flow, stroke, cerebrovascular, aging, cerebrovascular hemodynamics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy young

healthy old

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2011
Last Updated
January 26, 2015
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01365104
Brief Title
Modulation of Cerebral Blood Flow Using Iron Chelators
Acronym
DFO
Official Title
Hypoxia-Inducible Transcription Factor 1 (HIF-1)in Vascular Aging
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Problem of Aging
Keywords
brain blood flow, stroke, cerebrovascular, aging, cerebrovascular hemodynamics

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy young
Arm Type
Experimental
Arm Description
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.
Arm Title
healthy old
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
desferrioxamine
Other Intervention Name(s)
Desferal, desferoxamine
Intervention Description
intravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg.
Primary Outcome Measure Information:
Title
Define change from baseline cerebral blood flow after receiving DFO infusion.
Description
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.
Time Frame
baseline, 3hr, 6hr, 9hr
Title
Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics.
Description
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.
Time Frame
baseline, 3hr, 6hr, 9hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzaneh Sorond, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26304864
Citation
Sorond FA, Tan CO, LaRose S, Monk AD, Fichorova R, Ryan S, Lipsitz LA. Deferoxamine, Cerebrovascular Hemodynamics, and Vascular Aging: Potential Role for Hypoxia-Inducible Transcription Factor-1-Regulated Pathways. Stroke. 2015 Sep;46(9):2576-83. doi: 10.1161/STROKEAHA.115.009906. Epub 2015 Jul 30.
Results Reference
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Modulation of Cerebral Blood Flow Using Iron Chelators

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