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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06434025
Other study ID # 78861724.0.0000.5327
Secondary ID 2023-0428
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 24, 2024
Est. completion date November 24, 2026

Study information

Verified date May 2024
Source Hospital de Clinicas de Porto Alegre
Contact LUIS BECK DA SILVA, MD ScD
Phone 55 51 997330870
Email lbneto@hcpa.edu.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 after administration of intravenous iron and to assess changes in left ventricular function in patients with HFrEF and iron deficiency. Methods. Ninety-nine outpatient with symptomatic HFrEF, left ventricular ejection fraction (LVEF) <40%, SGLT2i naive, and iron deficiency will be assigned, to receive intravenous iron + SGLT2i; or intravenous iron + placebo of SGLT2i; or placebo of both therapies for 30 days. Myocardial iron will be evaluated by T2-star (T2*) cardiac magnetic resonance (CMR) sequencing before intravenous iron infusion. After 30 days, all patients will be reassessed by T2* CMR sequencing. The primary endpoint will be changes in LVEF and myocardial iron content at 30 days. Secondary endpoints will include correlations of these changes with myocardial iron content, functional capacity, quality of life, and cardiac biomarkers. Conclusions. This study will determine the effect of ferric carboxymaltose and its combination with SGLT2i on LVEF and its relationship with measures of myocardial iron content, functional capacity, and biomarkers in HFrEF and iron deficiency.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 99
Est. completion date November 24, 2026
Est. primary completion date May 24, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age 18 years or over; 2. Ejection fraction (EF) =40%, estimated by color Doppler echocardiography or CMR or radionuclide ventriculography; 3. Serum ferritin <100 µg/L or serum ferritin between 100 and 299 µg/L and transferrin saturation <20%; 4. Serum hemoglobin between 9.5 and 13.5 mg/dL; 5. Patients must be SGLT2 naive; 6. Informed consent form (ICF) signed. Exclusion Criteria: 1. Kidney disease requiring dialysis or chronic kidney disease not requiring dialysis with an estimated glomerular ?ltration rate <30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; 2. Severe primary valve disease; 3. Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months; 4. Patients already being treated for some type of non-iron de?ciency anemia; 5. Blood transfusion within 30 days prior to CMR examination; 6. Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator; 7. Diagnosis of hemochromatosis.

Study Design


Intervention

Drug:
Iron Carboxymaltose
Iron Carboxymaltose 500 mg. 2 vials administered IV.
Dapagliflozin 10mg Tab
Dapagliflozin 10mg Tab, PO, onde a day.
Placebo of Iron Carboxymaltose
Solution Sodium Chloride 0,9% 100 ml, IV, once.
Placebo of Dapagliflozin
Equal shape and appearance tab as the tab containing Dapagliflozin 10 mg

Locations

Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre RS

Sponsors (2)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre Vifor Pharma

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other six minute walk test (6MWT) distance walked in six minute walk test 30 days
Other NT-proBNP NT-terminal pro-B-type natriuretic peptide (NT-proBNP) levels 30 days
Other MLHFQ Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire 30 days
Other Hepcidin Serum Hepcidin levels 30 days
Other Reticulocyte hemoglobin content Reticulocyte hemoglobin content 30 days
Other Transferrin soluble receptors Transferrin soluble receptors 30 days
Other Glomerular filtration rate Glomerular filtration rate 30 days
Primary left ventricular function assessed (LVEF) by CMR. LVEF assessed by Cardiac Magnetic Resonance 30 days
Secondary Myocardial iron content assessed by T2* CMR Myocardial iron content assessed by T2* CMR 30 days
Secondary myocardial strain assessed by T2* CMR myocardial strain assessed by T2* CMR 30 days
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