Intravenous iron treatment for patients with non-ischaemic heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effects of intravenous ferric derisomaltose on patients with non-ischaemic heart failure and iron deficiency. Participants will undergo a series of baseline assessments, including laboratory tests, cardiac imaging, and functional tests, before receiving the treatment. Follow-up assessments will be conducted at 24 hours and 30 days post-treatment to monitor changes in their condition. The study focuses on patients who are already on heart failure therapy, including SGLT2 inhibitors, to ensure optimal management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Where it's running

• University Hospital Southampton NHS Foundation Trust
  Southampton, Hampshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Andrew S Flett, MBBS BSc MD — University Hospital Southampton NHS Foundation Trust
• Study coordinator: Flett
• Email: andrew.flett@uhs.nhs.uk
• Phone: +442381205906

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

• Iron absorption from a hydrogel iron supplement with and without breakfast

  This study tests how well three low-dose hydrogel iron supplements are absorbed in non-anemic, iron-depleted women, compared with regular ferrous fumarate, using labeled iron to measure absorption.

  Recruiting ETH Zurich · Zurich, Canton of Zurich · NCT07921433

• Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS

  Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07912086

• Tailored digital support to cut sedentary time in long-term cardiac rehab

  In adults in a long-term cardiac rehabilitation program, this study tests whether a personalized behavioural program with digital tools can reduce daily sitting time.

  Recruiting University of Lisbon · Lisbon, Lisbon District · NCT07910812

• NT-proBNP–guided heart failure screening for people 65+ in rural China

  This study tests whether using NT-proBNP blood tests to guide heart failure screening in adults 65 and older in rural China can find unrecognized heart problems more effectively than symptom-based screening.

  Recruiting Jiangsu Taizhou People's Hospital · Nanjing · NCT07885488

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.