NCT06434025Not yet recruitingPhase 3
IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency
Effect of Combination of Intravenous Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Patients With Heart Failure and Iron Deficiency.
Source: ClinicalTrials.gov · Last updated 3 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content. This study aims to measure cardiac magnetic resonance changes in myocardial iron content and in left ventricular function after administration of intravenous iron with and without the concomitant use of SGLT2 inhibitor in patients with HFrEF and iron deficiency.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- First submitted
- 23 May 2024
- Start date
- 24 May 2024
- Primary completion date
- 24 May 2026
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Diseases
- Heart failure
- NCT number
- NCT06434025
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 99
- From 24 May 2024 to the primary completion date, 24 May 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.
Prior treatment
- Blood transfusion within 30 days prior to CMR examination;
Other illness
- Kidney disease requiring dialysis or chronic kidney disease not requiring dialysis with an estimated glomerular filtration rate \<30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation;
- Severe primary valve disease;
- Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months;
- Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator;
Other
- Patients already being treated for some type of non-iron deficiency anemia;
- Diagnosis of hemochromatosis.
Who the study is looking for
- Age 18 years or over;
- Ejection fraction (EF) ≤40%, estimated by color Doppler echocardiography or CMR or radionuclide ventriculography;
- Serum ferritin \<100 µg/L or serum ferritin between 100 and 299 µg/L and transferrin saturation \<20%;
- Serum hemoglobin between 9.5 and 13.5 mg/dL;
- Patients must be SGLT2 naive;
- Informed consent form (ICF) signed.
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 |
|---|---|---|---|
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.