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

2014-08-27 03:56:18 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Conditions

Atherosclerosis

Intervention

Ferritin reduction to 25 ng/ml by phlebotomy

Location

VA Medical Center, Birmingham
Birmingham
Alabama
United States
35233

Status

Completed

Source

Department of Veterans Affairs

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:18-0400

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Phlebotomy and Lifestyle and Diet Advices vs Lifestyle and Diet Advices Only in Patients With Dysmetabolic Liversiderosis

Insulin resistance-associated hepatic iron overload (IR-HIO), also defined as dysmetabolic iron overload syndrome or dysmetabolic liversiderosis, is a common cause or iron overload in Fran...

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PubMed Articles [5413 Associated PubMed Articles listed on BioPortfolio]

Ascorbate and ferritin interactions: consequences for iron release in vitro and in vivo and implications for inflammation.

This review discusses the chemical mechanisms of ascorbate-dependent reduction and solubilization of ferritin's ferric iron core and subsequent release of ferrous iron. The process is accelerated by l...

Erythropoietic Protoporphyria-related Hepatopathy Successfully Treated with Phlebotomy.

A 27-year-old man bearing an erythropoietic protoporphyria (EPP)-associated ferrochelatase (FECH) mutation was admitted to our hospital for general malaise and marked elevation of the serum levels of ...

Genome-wide association and gene-environment interaction study identifies variants in ALDH2 associated with serum ferritin in a Chinese population.

Ferritin is not only a biomarker of total iron status and systemic inflammation but is also associated with metabolic disorders. A number of genetic variations have been identified to affect serum fer...

Ferroportin Disease Caused by a Heterozygous Variant p.Cys326Phe in the SLC40A1 Gene and the Efficacy of Therapeutic Phlebotomy in Children.

Therapeutic phlebotomy is recommended for treating hereditary hemochromatosis. However, the procedure and its efficacy for children remain unclear. We describe a young female patient with ferroportin ...

Ferritin, metabolic syndrome and its components: A systematic review and meta-analysis.

Mechanisms for the association between iron stores and risk factors for diabetes and cardiovascular disease, such as metabolic syndrome (MetS) and its components, are still not clear. We evaluated the...

Medical and Biotech [MESH] Definitions

The protein components of a number of complexes, such as enzymes (APOENZYMES), ferritin (APOFERRITINS), or lipoproteins (APOLIPOPROTEINS).

The techniques used to draw blood from a vein for diagnostic purposes or for treatment of certain blood disorders such as erythrocytosis, hemochromatosis, polycythemia vera, and porphyria cutanea tarda.

Puncture of a vein to draw blood for therapeutic purposes. Bloodletting therapy has been used in Talmudic and Indian medicine since the medieval time, and was still practiced widely in the 18th and 19th centuries. Its modern counterpart is PHLEBOTOMY.

Iron-containing proteins that are widely distributed in animals, plants, and microorganisms. Their major function is to store IRON in a nontoxic bioavailable form. Each ferritin molecule consists of ferric iron in a hollow protein shell (APOFERRITINS) made of 24 subunits of various sequences depending on the species and tissue types.

Reduction of high-risk choices and adoption of low-risk quantity and frequency alternatives.

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