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Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN (IRONMAN)

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ClinicalTrials.gov Identifier: NCT02642562
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : October 24, 2017
Sponsor:
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Paul Kalra, University of Glasgow

Brief Summary:
This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.

Condition or disease Intervention/treatment Phase
Heart Failure Iron Deficiency Left Ventricular Systolic Dysfunction Drug: Iron (III) isomaltoside 1000 Phase 4

Detailed Description:

Chronic heart failure (CHF) is a very common medical problem. Despite improvements in treatment, many patients suffer limiting symptoms of shortness of breath and fatigue. Hospitalisation for CHF is common and life expectancy reduced. Many patients with CHF have a deficiency of iron (low iron levels or cannot use iron properly), and this is associated with poorer outcomes. Some small research studies have suggested that giving patients intravenous iron improves symptoms in the short term. It is unknown, however, whether correcting iron deficiency is beneficial to patients with CHF in the long term and whether it improves life expectancy and keeps them out of hospital. This study will help us answer these key questions.

This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.

The study will take place in about 50 secondary care sites (hospitals) across the UK. Participants will be recruited over a period of two years and will be followed up for a minimum of two and a half years (average duration of three years per participant). After the initial visits, participants will be seen every four months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Intravenous Iron Treatment vs Standard Care in Patients With Heart Failure and Iron Deficiency: a Randomised, Open-label Multicentre Trial (IRONMAN)
Study Start Date : August 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
No Intervention: Standard care
Participants in this arm will receive their usual care
Experimental: Standard care plus IV iron infusion

Iron to be administered as iron (III) isomaltoside 1000.

Infused over a minimum of 15 mins for doses up to and including 1000mg, and a minimum of 30 mins for doses >1000mg Body weight <50 kg: 20 mg/kg Hb ≥10 g/dL and body weight 50 to <70 kg: 1000 mg Hb ≥10 g/dL and body weight ≥70 kg: 20 mg/kg up to a max of 1500 mg Hb < 10 g/dL and body weight 50 to <70 kg: 20 mg/kg Hb < 10 g/dL and body weight ≥70 kg: 20 mg/kg up to a max of 2000 mg

Drug: Iron (III) isomaltoside 1000
Other Name: Monofer




Primary Outcome Measures :
  1. CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations) [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]

Secondary Outcome Measures :
  1. CV mortality [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  2. Hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations) [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  3. All-cause mortality [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  4. CV mortality or first hospitalisation for major CV event (stroke, myocardial infarction [MI], heart failure) [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  5. Physical domain of QoL (Minnesota Living With Heart Failure and EQ-5D) - this will be the difference between groups at 4 months and also at 20 months [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  6. Overall QoL assessment (Minnesota Living With Heart Failure and EQ-5D) - this will be the difference between groups at 4 months and also at 20 months [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  7. Combined all-cause mortality or first all-cause unplanned hospitalisation [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  8. Days dead or hospitalised at 2.5 years (minimum duration of follow-up) [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  9. Quality-adjusted days alive and out of hospital at 2.5 years [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  10. CV hospitalisation (first event) [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  11. All-cause hospitalisation (first event) [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  12. Death due to sepsis [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]
  13. Hospitalisation primarily for infection [ Time Frame: Minimum 2.5 years follow up from last patient recruited ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. LVEF <45% within the last 6 months using any conventional imaging modality
  3. New York Heart Association (NYHA) class II - IV
  4. Iron deficient - defined as TSAT <20% and/or ferritin <100 ug/L
  5. Evidence of being in a higher risk HF group:

    • Current (with intention to discharge in next 48 hours) or recent (within 6 months) hospitalisation for HF, or
    • Out-patients with NT-proBNP >250 ng/L in sinus rhythm or >1,000 ng/L in atrial fibrillation (or BNP of > 75 pg/mL or 300 pg/mL, respectively)
  6. Able and willing to provide informed consent

Exclusion Criteria:

  1. Haematological criteria: ferritin >400ug/L; haemoglobin <9.0, or >13 g/dL in women or >14g/dL in men; (B12 or folate deficiency should be corrected but do not exclude the patient)
  2. MDRD estimated glomerular filtration rate (eGFR) <15ml/min/1.73m2
  3. Chronic defined need for IV iron therapy
  4. Likely to need or already receiving erythropoiesis stimulating agents (ESA)
  5. Planned cardiac surgery or revascularisation or cardiac device implantation; within 3 months of a primary diagnosis of type 1 myocardial infarction (excluding small troponin elevations in the context of heart failure admissions), cerebrovascular accident (CVA), major CV surgery or percutaneous coronary intervention (PCI), cardiac device implantation or blood transfusion; on active cardiac transplant list; left ventricular assist device implanted
  6. Any of the following comorbidities: active infection (if the patient is suffering from a significant ongoing infection as judged by the investigator recruitment should be postponed until the infection has passed or is controlled by antibiotics), other disease with life expectancy of <2 years, active clinically relevant bleeding in the investigators opinion, known or suspected gastro-intestinal malignancy
  7. Pregnancy or women of childbearing potential (i.e. continuing menstrual cycle) not using effective contraception - see Appendix 3.
  8. Contra-indication to IV iron in the investigator's opinion according to current approved Summary of Product Characteristics: hypersensitivity to the active substance, to Monofer® or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)); known serious hypersensitivity to other parenteral iron products; non-iron deficiency anaemia (e.g. haemolytic anaemia); iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis); decompensated liver cirrhosis and hepatitis
  9. Participation in another intervention study involving a drug or device within the past 90 days (co-enrolment in observational studies is permitted)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642562


Contacts
Contact: Paul Kalra, MA MB BChir MD 02392 283650 Paul.kalra@porthosp.nhs.uk
Contact: Anna Cunnington 02392 286236 Anna.Cunnington@porthosp.nhs.uk

  Show 51 Study Locations
Sponsors and Collaborators
University of Glasgow
NHS Greater Glasgow and Clyde

Responsible Party: Paul Kalra, Chief Investigator, University of Glasgow
ClinicalTrials.gov Identifier: NCT02642562     History of Changes
Other Study ID Numbers: GN15CA190
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available when analysis of the main pre-specified endpoints, sub-groups and sub-studies have been completed.

Keywords provided by Paul Kalra, University of Glasgow:
Intravenous iron
PROBE design

Additional relevant MeSH terms:
Heart Failure
Anemia, Iron-Deficiency
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ventricular Dysfunction
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs