IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure

NCT06542822 | Recruiting DMC

• 1 other identifier: RHMCAR0640
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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). 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.

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

Outcome Measures

Primary Outcomes (1)

• Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging

  Changes in Ejection Fraction quoted in (%)

  24 Hours and 30 days

Secondary Outcomes (13)

• T1 Mapping quantified on Cardiac Magnetic Resonance Imaging

  24 Hours and 30 days

• T2 Mapping quantified on Cardiac Magnetic Resonance Imaging

  24 Hours and 30 Days

• Extracellular Volume (ECV) Fraction quantified on Cardiac Magnetic Resonance Imaging

  24 Hours and 30 Days

• Ventricular Volumes quantified on Cardiac Magnetic Resonance Imaging

  24 Hours and 30 Days

• Indexed Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging

  24 Hours and 30 Days

Study Arms (1)

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.

Drug: Ferric derisomaltose

Interventions

Ferric derisomaltose DRUG

See group descriptions

IRONHEART Observational Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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%

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure; Iron Deficiencies

Interventions

ferric derisomaltose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andrew S Flett, MBBS BSc MD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flett

CONTACT

+442381205906; andrew.flett@uhs.nhs.uk

Rachael Pulham

CONTACT

+442381205044; sponsor@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: August 7, 2024
• Study Start: April 15, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

GB (1)