Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN (IRONMAN)
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| ClinicalTrials.gov Identifier: NCT02642562 |
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Recruitment Status :
Completed
First Posted : December 30, 2015
Last Update Posted : October 28, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Heart Failure Iron Deficiency Left Ventricular Systolic Dysfunction | Drug: Ferric Derisomaltose | Phase 4 |
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 70 secondary care sites (hospitals) across the UK. Participants will be recruited over a period of about five years and will be followed up for a minimum of three months (average duration of about four years per participant). After the initial visits, participants will be seen every four months.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1160 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) |
| Actual Study Start Date : | August 2016 |
| Actual Primary Completion Date : | August 26, 2022 |
| Actual Study Completion Date : | August 26, 2022 |
| Arm | Intervention/treatment |
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No Intervention: Standard care
Participants in this arm will receive their usual care
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Experimental: Standard care plus IV iron infusion
Iron to be administered as iron (III) isomaltoside 1000 / ferric derisomaltose. Infused over a minimum of 15 mins for doses up to and including 1000mg, and a minimum of 30 mins for doses >1000mg Where Hb ≥10 g/dL, dosage according to body weight is as follows: Body weight <50 kg: 20 mg/kg; Body weight 50 to <70 kg: 1000 mg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 1500 mg. Where Hb <10 g/dL, dosage according to body weight is as follows: Body weight <50 kg: 20 mg/kg; Body weight 50 to <70 kg: 20 mg/kg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 2000 mg. |
Drug: Ferric Derisomaltose
Other Name: Monofer |
- CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations) [ Time Frame: Minimum of 3 months follow-up from last patient recruited ]
- Hospitalisation for worsening heart failure (recurrent events) [ Time Frame: Minimum of 3 months follow-up from last patient recruited ]
- CV hospitalisation (first event) [ Time Frame: Minimum of 3 months follow-up from last patient recruited ]
- CV death or hospitalisation for heart failure analysed as time to first event [ Time Frame: Minimum of 3 months follow-up from last patient recruited ]
- Overall Score from Minnesota Living with Heart Failure [ Time Frame: At 4 months ]
- Cardiovascular mortality [ Time Frame: Minimum of 3 months follow-up from last patient recruited ]
- Overall EQ-5D VAS [ Time Frame: At 4 months ]
- Overall EQ-5D index [ Time Frame: At 4 months ]
- CV mortality or hospitalisation for major CV event (stroke, MI, heart failure) (first event) [ Time Frame: Minimum of 3 months follow-up from last patient recruited ]
- All-cause mortality [ Time Frame: Minimum of 3 months follow-up from last patient recruited ]
- All-cause hospitalisation (first event) [ Time Frame: Minimum of 3 months follow-up from last patient recruited ]
- Combined all-cause mortality or first all-cause unplanned hospitalisation [ Time Frame: Minimum of 3 months follow-up from last patient recruited ]
- Physical domain of QoL (Minnesota Living With Heart Failure) [ Time Frame: At 4 months ]
- Physical domain of QoL (Minnesota Living With Heart Failure) [ Time Frame: At 20 months ]
- Overall EQ-5D VAS [ Time Frame: At 20 months ]
- Overall EQ-5D index [ Time Frame: At 20 months ]
- Overall Score from Minnesota Living With Heart Failure [ Time Frame: At 20 months ]
- Days dead or hospitalised [ Time Frame: At 36 months ]
- Quality-adjusted days alive and out of hospital [ Time Frame: At 12 months ]
- 6 minute walk test [ Time Frame: At 4 months ]
- 6 minute walk test [ Time Frame: At 20 months ]
- Death due to infection [ Time Frame: Minimum of 3 months follow-up from last patient recruited ]
- Hospitalisation primarily for infection (first event) [ Time Frame: Minimum of 3 months 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 |
Inclusion criteria
- Age ≥18 years
- LVEF ≤45% within the prior two years using any conventional imaging modality (this should be the most recent assessment of LVEF)
- New York Heart Association (NYHA) class II - IV
- Iron deficient - defined as TSAT <20% and/or ferritin <100 ug/L
- Evidence of being in a higher risk HF group: (a) Current (with the expectation that patient will survive to discharge) or recent (within 6 months) hospitalisation for HF, OR (b) 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)
- Able and willing to provide informed consent
Exclusion criteria
- 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)
- MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) <15ml/min/1.73m2
- Already planned to receive IV iron
- Likely to need or already receiving erythropoiesis stimulating agents (ESA)
- Any of the following apply: (a) planned cardiac surgery or revascularisation; (b) within 3 months of any of the following: 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), or blood transfusion; (c) on active cardiac transplant list; (d) left ventricular assist device implanted.
- 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 investigator's opinion, known or suspected gastro-intestinal malignancy
- Pregnancy, women of childbearing potential (i.e. continuing menstrual cycle) not using effective contraception (see Appendix 3) or breast-feeding women
- 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 disease.
- Participation in another intervention study involving a drug or device within the past 90 days (co-enrolment in observational studies is permitted)
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
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| Study Chair: | Nicholas Boon | Chair of Steering Committee (Retired) |
| Responsible Party: | Paul Kalra, Chief Investigator, University of Glasgow |
| ClinicalTrials.gov Identifier: | NCT02642562 |
| Other Study ID Numbers: |
GN15CA190 |
| First Posted: | December 30, 2015 Key Record Dates |
| Last Update Posted: | October 28, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Applications for data access will be considered when analysis of the main pre-specified endpoints, sub-groups and sub-studies, and other sub-analyses have been completed. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Applications for access will be considered when analysis of the main pre-specified endpoints, sub-groups and sub-studies, and other sub-analyses have been completed. |
| Access Criteria: | Applications for access will be reviewed by the study Steering Committee. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Intravenous iron PROBE design |
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Heart Failure Ventricular Dysfunction, Left Anemia, Iron-Deficiency Iron Deficiencies Heart Diseases Cardiovascular Diseases |
Iron Metabolism Disorders Metabolic Diseases Anemia, Hypochromic Anemia Hematologic Diseases Ventricular Dysfunction |