NCT06542822Recruiting
IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 16 (estimated)
- First submitted
- 2 Jul 2024
- Start date
- 15 Apr 2024
- Primary completion date
- Feb 2026
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Diseases
- Heart failure
- NCT number
- NCT06542822
What you commit to
- Study type: Observational
- Planned participants: 16
- From 15 Apr 2024 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- New York Heart Association classification Score \>IV
- 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
Lab values
- Chronic kidney stage: Estimated Glomerular Filtration Rate (eGFR) \< 30
Other
- Ischaemic cardiomyopathy
- Requirement for renal dialysis
- Atrial fibrillation / atrial flutter
- Pregnancy
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.