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Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease

NCT00384657 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-12-22

No results posted yet for this study

Summary

Recently, growing body of evidence support the finding that anemia frequently occurs in patients with chronic heart failure (CHF). Chronic kidney disease (CKD), as well, is highly prevalent among heart failure patients, and both anemia and CKD are independently associated with increased mortality. A vicious circle is established with CHF causing both chronic renal insufficiency and anemia, and CKD further aggravating anemia which, in turn, worsens CHF and so on. Treatment of the anemia breaks this circle and improves the quality of life, cardiac and renal functions in patients with severe CHF.

Intravenous iron alone was proved to allow the maintenance of target hematocrit in one-third of chronic renal failure predialysis patients.

Based on these considerations, intravenous iron for anemia in patients with CHF and moderate CKD would represent a reasonable therapeutic approach.

The aim of the trial is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with CHF NYHA III class and concomitant moderate CKD.

Conditions

Interventions

DRUG

iron sucrose

Patients in Group I will receive iv iron sucrose, as described in the study protocol. Patient in Group II will receive conventional treatment for chronic heart failure.

Sponsors & Collaborators

  • Anemia Working Group Romania

    lead OTHER

Principal Investigators

  • Gabriel Mircescu, Professor · Dr Carol Davila Teaching Hospital of Nephrology

  • Tiberiu Nanea, Professor · "Caritas" Teaching Hospital, Bucharest

  • Liliana Garneata, MD, PhD · Dr Carol Davila Teaching Hospital of Nephrology Bucharest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Romania

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00384657 on ClinicalTrials.gov