This study has successfully completed the feasibility phase. Forty-seven patients were enrolled at two sites. The results of the preliminary data indicated that the volumes of blood donated and the frequency of donation were well accepted by patients and safe. It also indicated that the formula for calculating volumes of blood to be removed to achieve the targeted reduction in Total Body Iron Stores (TBIS) was accurate and representative of the ferritin equivalence in storage iron found by others could be achieved.

Condition	Treatment or Intervention	Phase
Reduction of Total Body Iron Storage(TBIS) Atherosclerosis Intermittent Claudication	Procedure: Ferritin reduction to 25 ng/ml by phlebotomy	Phase II Phase III

Further Study Details: 

Expected Total Enrollment:  1600

Intervention: Ferritin reduction to 25 ng/ml by phlebotomy every 6 months vs placebo. Minimum follow-up for each patient is 2.5 years.

Primary Hypothesis: Reduction of Total Body Iron Storage(TBIS) to a ferritin equivalent of approximately 25 ng/ml will alter mortality in a population of patients with advanced PVD.

Secondary Hypothesis: Reduction of TBIS to the same ferritin level will alter vascular disease morbidity in the same PVD patients population.

Primary Outcomes: Primary endpoint is mortality. Secondary endpoints include rates of non-fatal myocardial infarction and stroke, and the need for vascular intervention procedures.

Study Abstract: This study has successfully completed the feasibility phase. Forty-seven patients were enrolled at two sites. The results of the preliminary data indicated that the volumes of blood donated and the frequency of donation were well accepted by patients and safe. It also indicated that the formula for calculating volumes of blood to be removed to achieve the targeted reduction in Total Body Iron Stores (TBIS) was accurate and representative of the ferritin equivalence in storage iron found by others could be achieved.

This full study will last for six years. There will be 3.5 years of enrollment and a minimum of 2.5 years of follow-up for all study patients. It will involve a total of 1600 patients being recruited currently at 23 sites. Study patients will be seen every six months. Patients randomized to the ferritin reduction group will be monitored and have blood drawn to reach their targeted level of ferritin reduction of 25 ng/ml. The entry criteria will be the same as the feasibility study; however, the way patients will be stratified has changed. In the feasibility study, patients were stratified on the basis of their LDL/HDL ratios only. In this full study patients will be stratified on the basis of their entry LDL/HDL ratios as well as site, age, baseline ferritin level, smoking and diabetes status. Should the hypothesis of this study be confirmed, the results stand to have a considerable impact on health care delivery and cost of care.

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Patients with PVD.

Alabama
      Birmingham VA Medical Center, Birmingham,  Alabama,  35233,  United States
Arkansas
      Little Rock VA Medical Center, Little Rock,  Arkansas,  72205,  United States
California
      Long Beach VA Medical Center, Long Beach,  California,  90822,  United States
      VA Palo Alto Health Care System, Palo Alto,  California,  94304,  United States
Connecticut
      West Haven VA Medical Center, West Haven,  Connecticut,  06516,  United States
Florida
      Gainesville VA Medical Center, Gainesville,  Florida,  32608-1197,  United States
Illinois
      Hines VA Hospital, Hines,  Illinois,  60141,  United States
Kansas
      Leavenworth VA Eastern Kansas Health Care System, Leavenworth,  Kansas,  66048,  United States
Kentucky
      Lexington VA Medical Center, Lexington,  Kentucky,  40511-1093,  United States
      Louisville VA Medical Center, Louisville,  Kentucky,  40206,  United States
Nevada
      Reno VA Medical Center, Reno,  Nevada,  89520,  United States
New York
      Albany Stratton VA Medical Center, Albany,  New York,  12208,  United States
      New York VA Medical Center, New York,  New York,  10010,  United States
North Carolina
      Durham VA Medical Center, Durham,  North Carolina,  27705,  United States
Ohio
      Cleveland VA Medical Center, Cleveland,  Ohio,  44106,  United States
Pennsylvania
      VA Pittsburgh Health Care System (UD), Pittsburgh,  Pennsylvania,  15213,  United States
Texas
      Houston VA Medical Center, Houston,  Texas,  77030,  United States
Utah
      Salt Lake City VA Medical Center, Salt Lake City,  Utah,  84148,  United States
Vermont
      White River Junction VA Medical and Regional Office Center, White River Junction,  Vermont,  05009,  United States
Wisconsin
      Wm. S. Middleton Madison Veterans Hospital, Madison,  Wisconsin,  53705,  United States
      Milwaukee Zablocki VA Medical Center, Milwaukee,  Wisconsin,  53295,  United States
Puerto Rico
      San Juan VA Medical Center, San Juan,  00921-3201,  Puerto Rico

Study ID Numbers:  410
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  March 19, 2002
ClinicalTrials.gov Identifier:  NCT00032357
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08