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IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency

ConditionsHeart Failure, SystolicIron Deficiencies
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital de Clinicas de Porto Alegre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 already being treated for some type of non-iron deficiency anemia;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iron Carboxymaltose

    Drug

    Iron Carboxymaltose 500 mg. 2 vials administered IV.

  • Dapagliflozin 10mg Tab

    Drug

    Dapagliflozin 10mg Tab, PO, onde a day.

  • Placebo of Iron Carboxymaltose

    Drug

    Solution Sodium Chloride 0,9% 100 ml, IV, once.

  • Placebo of Dapagliflozin

    Drug

    Equal shape and appearance tab as the tab containing Dapagliflozin 10 mg

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: ferric carboxymaltose + SGLT2 inhibitorExperimental treatment 2 interventions
Group B: ferric carboxymaltose + placebo of SGLT2 inhibitorActive comparator 2 interventions
Group C: Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitorPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

left ventricular function assessed (LVEF) by CMR.

LVEF assessed by Cardiac Magnetic Resonance

Time frame
30 days

Secondary outcomes

1

Myocardial iron content assessed by T2* CMR

Myocardial iron content assessed by T2\* CMR

Time frame
30 days
2

myocardial strain assessed by T2* CMR

myocardial strain assessed by T2\* CMR

Time frame
30 days

Other outcomes

1

six minute walk test (6MWT)

distance walked in six minute walk test

Time frame
30 days
2

NT-proBNP

NT-terminal pro-B-type natriuretic peptide (NT-proBNP) levels

Time frame
30 days
3

MLHFQ

Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire

Time frame
30 days
4

Hepcidin

Serum Hepcidin levels

Time frame
30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital de Clinicas de Porto Alegre

Lead sponsor

Vifor Pharma

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: