Effect of Iron on Cardiac Energy Levels in Patients with Heart Failure and Iron Deficiency: The Ferric Iron in Heart Failure (FERRIC-HF) III Trial.

Phase 1

• Conditions: Chronic Heart Failure; MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849; MedDRA version: 20.0 Level: PT Classification code 10022970 Term: Iron deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-004667-13-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

•Aged 18 to 89 years
•Ferritin <100 mcg/l or Ferritin 100 – 300 mcg/l with TSAT <20%
•Anaemic group (50% of study population): Hb <120 g/L in Females and Hb <130 g/L in Males
•Non-anaemic group (50% of study population): Hb =120 g/L in Females and =130 g/L in Males
•Stable New York Heart Association (NYHA) class II-IV symptoms for the preceding 4 weeks
•LVEF = 45% assessed by Echocardiography or Cardiac MRI within the preceding 6 months
•On optimally tolerated heart failure drugs for = 4 weeks with no changes (dose or medication type) for the preceding 2 weeks
•Resting blood pressure = 160/100mmHg
•Negative pregnancy test in premenopausal females.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

•Inability to provide written informed consent
•Inability to sufficiently understand information pertaining to the conduct of the trial
•Contraindications to 31P-MRS (e.g. pacemaker, metal prosthesis, etc)
•Ischaemic cardiomyopathy
•Folate and vitamin B12 levels below laboratory normal limit.
•Use of erythropoietic agent, blood transfusion or immunosuppressive therapy in the preceding 30 days, or ongoing anticipated need for these agents during the study.
•Acute or chronic bleeding, infective or inflammatory disorders (Rheumatoid Arthritis, Lupus, HIV/AIDS, malignancy, etc.)
•History of iron overload or haemochromatosis in patient or first degree relatives.
•Prior intolerance to intravenous iron formulations or any of their excipients
•Chronic liver disease and/or aspartate transaminase (AST) >3 times the upper limit of the normal range
•Renal dialysis (Haemodialysis or peritoneal dialysis)
•Severe asthma or any severe lung disease with FEV1<50% of predicted or necessitating domicillary oxygen or non-invasive ventilation.
•Severe atopic disorder including eczema or any prior anaphylactoid / anaphylactic reaction.
•Haemolytic or myelodysplastic anaemia
•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
•Contemporaneous enrolment in another clinical trial

Study & Design

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