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

Tracking Information

First Received Date ^ICMJE

May 31, 2011

Last Updated Date

February 14, 2013

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01365104 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Modulation of Cerebral Blood Flow Using Iron Chelators

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

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

Condition ^ICMJE

Stroke
Problem of Aging

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

105

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01365104

Other Study ID Numbers ^ICMJE

1K23AG030967-01, 1K23AG030967-01A1

Has Data Monitoring Committee

Yes

Responsible Party

Farzaneh Sorond, Brigham and Women's Hospital

Study Sponsor ^ICMJE

Brigham and Women's Hospital

Collaborators ^ICMJE

National Institute on Aging (NIA)

Investigators ^ICMJE

Principal Investigator:

Farzaneh Sorond, MD, PhD

Brigham and Women's Hospital

Information Provided By

Brigham and Women's Hospital

Verification Date

February 2013

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

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