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.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032357
First received: March 19, 2002
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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
Atherosclerosis
Intermittent Claudication
Peripheral Vascular Diseases
Procedure: Ferritin reduction to 25 ng/ml by phlebotomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 Department of Veterans Affairs:

Primary Outcome Measures:
  • Mortality [ Time Frame: The minimum follow-up was 3.5 years and maximum follow-up was 6 years ] [ Designated as safety issue: No ]
    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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  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.

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

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Sponsors and Collaborators
Investigators
Study Chair: Zacharski R. Leo VA Medical & Regional Office Center, White River
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032357     History of Changes
Other Study ID Numbers: 410
Study First Received: March 19, 2002
Last Updated: January 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Ferritin reduction
Peripheral Vascular Disease (PVD)
phlebotomy
Reduction of Total Body Iron Storage(TBIS)
Total Body Iron Storage(TBIS)

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Intermittent Claudication
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014