Heart FailureIRONHEARTNCT06542822
IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
An observational study of Heart Failure and Iron Deficiencies, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to observe the effect of intravenous ferric derisomaltose in participants with non-ischaemic heart failure (LVEF<40%), iron deficiency (TSATS<20%) and established on heart failure therapy including Sodium-glucose cotransporter 2 inhibitors (SGLT2i). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Iron Deficiencies
- What is being tested?
- Ferric derisomaltose
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2024to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with non-ischaemic cardiomyopathy with a left ventricular function less than 40% and iron deficient as per the following criteria: Transferrin saturations < 20%
Who may be able to join
- Participants capable of giving informed consent.
- Aged 18yrs and above.
- Diagnosed with heart failure and a reduction of their ejection fraction < 40% by any modality.
- Non ischaemic cardiomyopathy as determined by baseline cardiac magnetic resonance imaging.
- Iron deficient per this definition: Transferrin saturations < 20%.
- Established on Heart failure therapy including SGLT2i therapy for a minimum of four weeks prior to recruitment.
- New York Heart Association score of I - III class.
Who cannot join
- New York Heart Association classification Score >IV
- Ischaemic cardiomyopathy
- Chronic kidney stage: Estimated Glomerular Filtration Rate (eGFR) < 30
- Requirement for renal dialysis
- Atrial fibrillation / atrial flutter
- Non cardiac and cardiac palliative diagnosis
Show all 13Show fewer
- Active cancer diagnosis
- Moderate to severe valvular heart disease
- Cardiac electronic implantable device: Cardiac resynchronization therapy, Implantable cardioverter-defibrillator, left ventricular assist device
- Cardiac \& non cardiac transplant participants
- Myocardial infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft surgery in the last 30 days
- Complex congenital heart disease
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
Andrew S Flett, MBBS BSc MD, +442381205906, andrew.flett@uhs.nhs.uk
About this study
Official title: Immediate Effects of Intravenous Iron Therapy in Patients With Systolic Heart Failure and Iron Deficiency as Evaluated by Cardiac Magnetic Resonance Imaging: An Observational Prospective Study
The aim of this study is to observe the effect of intravenous ferric derisomaltose in participants with non-ischaemic heart failure (LVEF<40%), iron deficiency (TSATS<20%) and established on heart failure therapy including Sodium-glucose cotransporter 2 inhibitors (SGLT2i). Participants will undergo baseline laboratory blood tests, cardiac magnetic resonance imaging (cMRI), six-minute walk test, musculoskeletal function test and Kansas City Cardiomyopathy Questionnaire (KCCQ). These investigations will be repeated at 24 hours and 30 days after the administration of intravenous ferric derisomaltose.
Read the detailed description
Heart failure is a neuro-endocrine syndrome in which patients report symptoms of breathlessness and lethargy accompanied with signs of fluid overload.
Iron deficiency is very common in heart failure, affecting up to 50% of patients. Its presence in this population is associated with worsening symptoms and increased risk of death. Human clinical trials have shown that administering intravenous iron improves quality of life and exercise tolerance. The European Society Guidelines gives a 1A class recommendation for intravenous iron replacement in symptomatic heart failure patients.
Iron is an essential micro-nutrient required in mitochondrial metabolism, handling of reactive oxygen species and cellular metabolism. Heart failure leads to a pro inflammatory state, resulting in reduced gastrointestinal absorption, and inhibition of iron mobilisation. Mouse models have shown reversal of cardiac fibrosis, cardiac remodelling, and reduction in the pro inflammatory state when treated with intravenous iron. Similarly iron deficient human cardiomyocytes show adverse remodelling and altered function reversed with iron repletion.
The investigators aim to recruit 16 participants with non-ischaemic heart failure, established on optimal medical therapy, including SGLT2i therapy, for four weeks prior to the start of the trial. Initial baseline investigations will include: cMRI, six-minute walk test, hand grip strength test, laboratory blood tests and a KCCQ-12. Intravenous ferric derisomaltose will be given as standard of care. These investigations will be repeated at 24 hours and at 30 days after the administration of intravenous ferric derisomaltose.
The study aims to observe changes pre and post administration of intravenous derisomaltose in the following:
- Changes in cardiac function and parametric measurements (T1/T2) as assessed by cardiac magnetic resonance imaging.
- Changes in high sensitivity troponin, N Terminal pro-Brain Natriuretic Peptide (NT pro-BNP) and serum phosphate levels.
- Changes in the submaximal exercise test (six-minute walk) and musculoskeletal function test (hand grip test).
- Changes in heart failure symptoms as assessed by KCCQ Questionnaire.
- Conditions
- Heart Failure, Iron Deficiencies
- Being tested
- Ferric derisomaltose
- Keywords
- Ferric derisomaltose, Non-ischaemic heart failure, Chronic heart failure, Iron deficiency, Left ventricular failure, Iron homeostasis, Cardiac MRI, Cardiac Magnetic resonance imaging
- Medical subject headings
- Heart Failure, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric derisomaltoseDrug
See group descriptions
| Study group | Role | What they receive |
|---|---|---|
| IRONHEART Observational Study Group | 16 participants, with non-ischaemic heart failure, with iron deficiency TSATS <20% and heart failure with a reduced ejection fraction <40%.
Cohort will have to be established on guideline directed heart failure therapy. Participants meeting eligibility criteria will undergo baseline quality of life questionnaires, hand grip tests and six minute walk tests before receiving intravenous iron derisomaltose and repeating these investigations again after 24 hours and 30 days including a cardiac magnetic resonance imaging. Receives: Drug: Ferric derisomaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging
Changes in Ejection Fraction quoted in (%)
Measured: 24 Hours and 30 days
Secondary outcomes (13)
T1 Mapping quantified on Cardiac Magnetic Resonance Imaging
Changes in T1 Parametric Mapping quantified in (msec)
Measured: 24 Hours and 30 days
T2 Mapping quantified on Cardiac Magnetic Resonance Imaging
Changes in T2 Parametric Mapping quantified in (msec)
Measured: 24 Hours and 30 Days
Extracellular Volume (ECV) Fraction quantified on Cardiac Magnetic Resonance Imaging
Changes in ECV Fraction quoted in (%)
Measured: 24 Hours and 30 Days
Ventricular Volumes quantified on Cardiac Magnetic Resonance Imaging
Changes in left and right ventricular volumes quantified in (ml)
Measured: 24 Hours and 30 Days
Indexed Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging
Changes in indexed left and right ventricular volumes. Weight and Height will be combined to calculate Body Surface Area (m2). Left Ventricular Volume in (ml) will be divided by Body Surface Area to give indexed value (ml/m2)
Measured: 24 Hours and 30 Days
Strain analysis as quantified on Cardiac Magnetic Resonance Imaging
Changes in strain as assessed by feature tracking on cardiac magnetic resonance imaging
Measured: 24 Hours and 30 Days
Quality of Life assessment: KCCQ-12 questionnaire
Changes in Kansas City Cardiomyopathy Questionnaire. Four sub-domains: Physical limitation, Symptom Frequency, Quality of life and social limitations. Scores range from 0 - 100, with higher scores reflecting a better heart status.
Measured: 24 Hours and 30 Days
Submaximal Exercise Test: Six Minute Walk Test
Changes in distance walked (meters) in six minutes
Measured: 24 Hours and 30 Days
Musculoskeletal function test: Hand grip test
Changes in Isometric Grip Force in (KG)
Measured: 24 Hours and 30 Days
Haemoglobin
Laboratory Blood Test
Measured: 30 Days
High Sensitivity troponin
Laboratory Blood Test
Measured: 24 Hours and 30 Days
Phosphate
Laboratory Blood Test
Measured: 24 Hours and 30 Days
N-terminal pro B type natriuretic peptide (NTproBNP)
Laboratory Blood Test
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start15 Apr 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Andrew S Flett, MBBS BSc MD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542822
- Sponsor's protocol ID
- RHMCAR0640
- Acronym
- IRONHEART
- Status last verified
- Aug 2024
- First submitted
- 2 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Intravenous Iron Therapy in Patients With Systolic Heart Failure and Iron Deficiency as Evaluated by Cardiac Magnetic Resonance Imaging: An Observational Prospective Study
- ClinicalTrials.gov ID
- NCT06542822
- Acronym / sponsor ID
- IRONHEART / RHMCAR0640
- Conditions
- Heart Failure, Iron Deficiencies
- Keywords
- Ferric derisomaltose, Non-ischaemic heart failure, Chronic heart failure, Iron deficiency, Left ventricular failure, Iron homeostasis, Cardiac MRI, Cardiac Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to observe the effect of intravenous ferric derisomaltose in participants with non-ischaemic heart failure (LVEF<40%), iron deficiency (TSATS<20%) and established on heart failure therapy including Sodium-glucose cotransporter 2 inhibitors (SGLT2i). Participants will undergo baseline laboratory blood tests, cardiac magnetic resonance imaging (cMRI), six-minute walk test, musculoskeletal function test and Kansas City Cardiomyopathy Questionnaire (KCCQ). These investigations will be repeated at 24 hours and 30 days after the administration of intravenous ferric derisomaltose.
Detailed description
Heart failure is a neuro-endocrine syndrome in which patients report symptoms of breathlessness and lethargy accompanied with signs of fluid overload.
Iron deficiency is very common in heart failure, affecting up to 50% of patients. Its presence in this population is associated with worsening symptoms and increased risk of death. Human clinical trials have shown that administering intravenous iron improves quality of life and exercise tolerance. The European Society Guidelines gives a 1A class recommendation for intravenous iron replacement in symptomatic heart failure patients.
Iron is an essential micro-nutrient required in mitochondrial metabolism, handling of reactive oxygen species and cellular metabolism. Heart failure leads to a pro inflammatory state, resulting in reduced gastrointestinal absorption, and inhibition of iron mobilisation. Mouse models have shown reversal of cardiac fibrosis, cardiac remodelling, and reduction in the pro inflammatory state when treated with intravenous iron. Similarly iron deficient human cardiomyocytes show adverse remodelling and altered function reversed with iron repletion.
The investigators aim to recruit 16 participants with non-ischaemic heart failure, established on optimal medical therapy, including SGLT2i therapy, for four weeks prior to the start of the trial. Initial baseline investigations will include: cMRI, six-minute walk test, hand grip strength test, laboratory blood tests and a KCCQ-12. Intravenous ferric derisomaltose will be given as standard of care. These investigations will be repeated at 24 hours and at 30 days after the administration of intravenous ferric derisomaltose.
The study aims to observe changes pre and post administration of intravenous derisomaltose in the following:
- Changes in cardiac function and parametric measurements (T1/T2) as assessed by cardiac magnetic resonance imaging.
- Changes in high sensitivity troponin, N Terminal pro-Brain Natriuretic Peptide (NT pro-BNP) and serum phosphate levels.
- Changes in the submaximal exercise test (six-minute walk) and musculoskeletal function test (hand grip test).
- Changes in heart failure symptoms as assessed by KCCQ Questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRONHEART Observational Study Group | – | Drug: Ferric derisomaltose16 participants, with non-ischaemic heart failure, with iron deficiency TSATS <20% and heart failure with a reduced ejection fraction <40%. Cohort will have to be established on guideline directed heart failure therapy. Participants meeting eligibility criteria will undergo baseline quality of life questionnaires, hand grip tests and six minute walk tests before receiving intravenous iron derisomaltose and repeating these investigations again after 24 hours and 30 days including a cardiac magnetic resonance imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with non-ischaemic cardiomyopathy with a left ventricular function less than 40% and iron deficient as per the following criteria: Transferrin saturations < 20%
Key inclusion criteria (7 listed)
- Participants capable of giving informed consent.
- Aged 18yrs and above.
- Diagnosed with heart failure and a reduction of their ejection fraction < 40% by any modality.
- Non ischaemic cardiomyopathy as determined by baseline cardiac magnetic resonance imaging.
- Iron deficient per this definition: Transferrin saturations < 20%.
Key exclusion criteria (13 listed)
- New York Heart Association classification Score >IV
- Ischaemic cardiomyopathy
- Chronic kidney stage: Estimated Glomerular Filtration Rate (eGFR) < 30
- Requirement for renal dialysis
- Atrial fibrillation / atrial flutter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric derisomaltoseSee group descriptions | Drug | IRONHEART Observational Study Group |
Primary outcome
Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging
Time frame: 24 Hours and 30 days
Changes in Ejection Fraction quoted in (%)
13 secondary outcomes
T1 Mapping quantified on Cardiac Magnetic Resonance Imaging
Time frame: 24 Hours and 30 days
T2 Mapping quantified on Cardiac Magnetic Resonance Imaging
Time frame: 24 Hours and 30 Days
Extracellular Volume (ECV) Fraction quantified on Cardiac Magnetic Resonance Imaging
Time frame: 24 Hours and 30 Days
Ventricular Volumes quantified on Cardiac Magnetic Resonance Imaging
Time frame: 24 Hours and 30 Days
Indexed Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging
Time frame: 24 Hours and 30 Days
Strain analysis as quantified on Cardiac Magnetic Resonance Imaging
Time frame: 24 Hours and 30 Days
Quality of Life assessment: KCCQ-12 questionnaire
Time frame: 24 Hours and 30 Days
Submaximal Exercise Test: Six Minute Walk Test
Time frame: 24 Hours and 30 Days
Musculoskeletal function test: Hand grip test
Time frame: 24 Hours and 30 Days
Haemoglobin
Time frame: 30 Days
High Sensitivity troponin
Time frame: 24 Hours and 30 Days
Phosphate
Time frame: 24 Hours and 30 Days
N-terminal pro B type natriuretic peptide (NTproBNP)
Time frame: 30 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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A Study of Bimagrumab in Participants With HFpEF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew S Flett, MBBS BSc MD principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Iron Deficiencies, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flett (+442381205906, andrew.flett@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging (time frame: 24 Hours and 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.