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

Completed · Phase 3

Conditions studied: Atherosclerosis, Intermittent Claudication, Peripheral Vascular Diseases

In brief

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.

Key facts

Study ID

NCT00032357

Run by

US Department of Veterans Affairs

People needed

1277

Starts

1999-05-01

Expected to finish

2005-09-01

Last updated by the study team

2013-01-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.
• Absence of a disturbance in Fe balance (e.g. hemosiderosis from any cause, hemochromatosis, atransferrinemia, PNH, Fe deficiency)
• Absence for at least six months of a disease that has caused bleeding (e.g. peptic ulcer, inflammatory bowel disease, hemorrhagic diathesis )
• 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.
• Absence of an associated obvious inflammatory disorder (e.g. infection, connective tis-sue disease) capable of elevating ferritin levels acutely.
• 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.
• Patients must agree to not take any Fe supplements or vitamins while on study.

You may not qualify if…

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

Where it is running

• VA Medical Center, Birmingham — Birmingham, Alabama, United States
• Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock — No. Little Rock, Arkansas, United States
• VA Medical Center, Long Beach — Long Beach, California, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• VA Connecticut Health Care System (West Haven) — West Haven, Connecticut, United States
• North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States
• James A. Haley Veterans Hospital, Tampa — Tampa, Florida, United States
• Edward Hines, Jr. VA Hospital — Hines, Illinois, United States
• VA Medical Center, Lexington — Lexington, Kentucky, United States
• VA Medical Center, Louisville — Louisville, Kentucky, United States
• VA Medical Center, Jamaica Plain Campus — Boston, Massachusetts, United States
• VA Sierra Nevada Health Care System — Reno, Nevada, United States
• VA Stratton Medical Center, Albany — Albany, New York, United States
• New York Harbor HCS — New York, New York, United States
• VA Medical Center, Durham — Durham, North Carolina, United States
• VA Medical Center, Cleveland — Cleveland, Ohio, United States
• VA Pittsburgh Health Care System — Pittsburgh, Pennsylvania, United States
• VA Medical Center, Providence — Providence, Rhode Island, United States
• Michael E. DeBakey VA Medical Center (152) — Houston, Texas, United States
• VA Salt Lake City Health Care System, Salt Lake City — Salt Lake City, Utah, United States
• VA Medical & Regional Office Center, White River — White River Junction, Vermont, United States
• Wlliam S. Middleton Memorial Veterans Hospital, Madison — Madison, Wisconsin, United States
• Zablocki VA Medical Center, Milwaukee — Milwaukee, Wisconsin, United States
• VA Medical Center, San Juan — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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