Iron replacement for congestive heart failure with iron deficiency

Phase 3

• Conditions: Congestive Heart Failure; Iron deficiency; Cardiovascular - Other cardiovascular diseases; Blood - Other blood disorders; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12614000154606
• Lead Sponsor: Haematology Department, Fremantle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male or female 18 years of age or above
2. Congestive heart failure of New York Heart Association (NYHA) functional class II or III, defined by left ventricular ejection fraction of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III)
3. Iron deficiency, defined by ferritin level <100 microg per liter or between 100 and 299 microg per liter, if the transferrin saturation is <20%
4. Haemoglobin level at the screening less than 135 g per liter
5. Written informed consent

Exclusion Criteria

1. Acute Heart Failure
2. Clinically significant Chronic Obstructive Pulmonary Disease, defined as moderate or worse on GOLD grading
3. Clinically significant liver impairment, defined as Child-Pugh class B or C
4. Clinically significant renal impairment, defined as Chronic Kidney Disease stage 5
5. Presence of other condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Study & Design

• Study Type: Interventional
• Study Design: Not specified