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Does the Reduction of Total Body Iron Storage (TBIS) Alter Mortality in a Population of Patients With Advanced PVD? (FeAST)

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ClinicalTrials.gov Identifier: NCT00032357
Recruitment Status : Completed
First Posted : March 20, 2002
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Veterans Affairs Cooperative Study #410, The Iron and Atherosclerosis Trial, FeAST, a 24-hospital prospective randomized single-blinded clinical trial of graded iron reduction was conducted between May 1, 1999 and April 30, 2005, and has now been completed. A total of 1,277 primarily male participants with peripheral arterial disease were entered. The primary outcome was all cause mortality and the secondary outcome combined death plus non-fatal myocardial infarction (MI) and stroke.

Condition or disease Intervention/treatment Phase
Atherosclerosis Intermittent Claudication Peripheral Vascular Diseases Procedure: Ferritin reduction to 25 ng/ml by phlebotomy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: CSP #410 - The Iron (Fe) and Atherosclerosis Study (FeAST)
Study Start Date : May 1999
Actual Primary Completion Date : April 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis Iron
U.S. FDA Resources

Arm Intervention/treatment
Arm 1
Usual care plus Ferritin reduction to a calculated nadir of 25 ng/mL by phlebotomy
Procedure: Ferritin reduction to 25 ng/ml by phlebotomy
No Intervention: Arm 2
Usual care only; no intervention control



Primary Outcome Measures :
  1. Mortality [ Time Frame: The minimum follow-up was 3.5 years and maximum follow-up was 6 years ]
    The primary objective of this study is to evaluate the effectiveness of a reduction of Total Body Iron Stores (TBIS) in decreasing the rate of all cause mortality in patients with peripheral vascular disease (PVD).



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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males over the age of 21 years and post menopausal (either natural or surgical) females with a diagnosis of intermittent claudication who are not scheduled for major surgery and who can give informed consent will be entered.
  2. Hematocrit of 30% or greater for females and 35% or greater for males, normal liver function, serum creatinine less than 4 mg/dl. Patients with mild anemia and mild creatinine elevation will be entered (provided the anemia is not due to Fe deficiency found on screening laboratory tests) because such findings are commonly present chronically in PVD.
  3. Absence of a disturbance in Fe balance (e.g. hemosiderosis from any cause, hemochromatosis, atransferrinemia, PNH, Fe deficiency)
  4. Absence for at least six months of a disease that has caused bleeding (e.g. peptic ulcer, inflammatory bowel disease, hemorrhagic diathesis )
  5. Absence of associated neoplasm other than epithelial ( non-melanoma) tumors of skin or other co-morbid condition that is expected to be fatal within one year.
  6. Absence of an associated obvious inflammatory disorder (e.g. infection, connective tis-sue disease) capable of elevating ferritin levels acutely.
  7. Patients will not be excluded on the basis of either the existence or severity of either coronary- or cerebrovascular disease, medication use including non-steroidal anti-inflammatory drugs and anticoagulants, coronary angiographic findings, previous history of or possible future need for angioplasty or coronary bypass surgery, or elevated blood pressure.
  8. Patients must agree to not take any Fe supplements or vitamins while on study.

Exclusion Criteria:

1. Patients must have at least one lower extremity and must not be on another experimental therapy protocol for atherosclerotic vascular disease.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032357


  Show 24 Study Locations
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Study Chair: Zacharski R. Leo VA Medical & Regional Office Center, White River

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00032357     History of Changes
Other Study ID Numbers: 410
First Posted: March 20, 2002    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by VA Office of Research and Development:
Ferritin reduction
Peripheral Vascular Disease (PVD)
phlebotomy
Reduction of Total Body Iron Storage(TBIS)
Total Body Iron Storage(TBIS)

Additional relevant MeSH terms:
Atherosclerosis
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Signs and Symptoms
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs