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

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: March 19, 2002
Last updated: January 18, 2013
Last verified: January 2013
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 Intervention Phase
Intermittent Claudication
Peripheral Vascular Diseases
Procedure: Ferritin reduction to 25 ng/ml by phlebotomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: CSP #410 - The Iron (Fe) and Atherosclerosis Study (FeAST)

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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).

Enrollment: 1277
Study Start Date: May 1999
Study Completion Date: September 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00032357

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


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT00032357     History of Changes
Other Study ID Numbers: 410
Study First Received: March 19, 2002
Last Updated: January 18, 2013

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

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
Arterial Occlusive Diseases
Cardiovascular Diseases
Signs and Symptoms
Trace Elements
Growth Substances
Physiological Effects of Drugs processed this record on April 26, 2017