Iron Infusion in Heart Failure Study

Phase 2

• Conditions: Chronic Heart Failure; Iron Deficiency; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12615000952549
• Lead Sponsor: Professor Andrew Sindone

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1) Chronic Heart Failure
2) Iron Deficiency
3) Patient willing and able to give consent

Exclusion Criteria

1) Patients with a significant condition which will affect their clinical status such as terminal malignancy, HIV infection, etc
2) Pregnant patients
3) Patients unable to complete the Kansas City Cardiomyopathy Questionnaire, PHQ9 Questionnaire, or a 6-minute walk test
4) Patients that underwent a major change in clinical status including hospitalization or introduction of a new heart failure medication over the last month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Kansas City Cardiomyopathy Questionnaire score [2 weeks after infusion]

Secondary Outcome Measures

Name	Time	Method
Change in Patient Health Questionnaire - 9 score[2 weeks after infusion];Change in NT pro-BNP levels, collected in serum and measured by the electrochemiluminescence immunoassay ECLIA on the Elecsys immunoassay analyzer[2 weeks after infusion];Change in ST-2 levels, collected in serum and measured by enzyme-linked immunosorbant assay using the Critical Diagnositcs Presage ST2 assay kit[2 weeks after infusion];Changes in 6-minute walk test distance[1 day, 1 week, and 2 weeks after infusion];Changes in stroke volume measured noninvasively via impedance cardiography[1 day, 1 week, and 2 weeks after infusion];Changes in hand grip strength measured by a hand held dynamometer[1 day, 1 week, and 2 weeks after infusion];Changes in cardiac output measured noninvasively via impedance cardiography[1 day, 1 week, and 2 weeks after infusion];Changes in cardiac index measured noninvasively via impedance cardiography[1 day, 1 week, and 2 weeks]