Mechanisms of Exercise Benefit with Intravenous Iron in Chronic Heart Failure

Phase 1

• Conditions: Chronic Heart Failure; MedDRA version: 18.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-005592-13-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-11
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

=30 years of age and have signed written informed consent
•Stable symptomatic CHF; NYHA III/IV and LVEF =45%, or if NYHA II then LVEF must be =40% as assessed within last 6 months using echocardiographic or magnetic resonance imaging techniques.
•On optimal conventional therapy for at least 4 weeks prior to recruitment and without dose changes for at least 2 weeks.
•Screening Hb concentration < 12 g/dl in females and < 13 g/dL in males (anaemic group, 50% of study population) or =12 g/dL in females and = 13 g/dL in males (non-anaemic group, 50% of study population).
•Ferritin <100 ?g/l or 100-300 ?g/l with TSAT <20%.
•Folate and Vitamin B12 levels = lower limit of normal (according to local lab reference range).
•Resting blood pressure =160/100 mmHg.
•Negative pregnancy test in women of child-bearing age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions).
•Known hypersensitivity to parental iron preparations or any of their excipients.
•Known active infection, bleeding, malignancy, haemolytic anaemia, and rheumatoid arthritis.
•History of chronic liver disease with alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the upper limit of the normal range, severe chronic lung disease with FEV1 < 50% predicted, myelodysplastic disorder, and known HIV/AIDS disease.
•Coagulopathy or anticoagulation with warfarin or warfarin substitutes for a metallic valve or an LV thrombus diagnosed in the last 6 months.
•Contraindications to magnetic resonance imaging (pacemaker, cardiac resynchronization therapy device, internal cardiac defibrillator, metal prostheses, excessive claustrophobia)
•Recipient of immunosuppressive therapy or renal dialysis.
•Anticipated need for erythropoietin or a blood transfusion during the study.
•Unstable angina as judged by the investigator, severe uncorrected non-functional valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, uncontrolled fast atrial fibrillation or flutter (>110 bpm), uncontrolled symptomatic brady- or tachyarrhythmias.
•Musculoskeletal limitation that, in the investigators judgement, would impair exercise testing.
•Pregnant or breast-feeding
•Inability to comprehend study protocol
•Parallel participation in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified