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Not yet recruiting NCT06434025

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

Phase III Interventional Heart Failure, Systolic Iron Deficiencies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iron Carboxymaltose, Dapagliflozin 10mg Tab, Placebo of Iron Carboxymaltose, Placebo of Dapagliflozin.
Who it may be relevant to
Registry conditions: Heart Failure, Systolic, Iron Deficiencies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Combination of Intravenous Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Patients With Heart Failure and Iron Deficiency.

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • left ventricular function assessed (LVEF) by CMR. [Time frame: 30 days]
Secondary outcome measures (2)
  • Myocardial iron content assessed by T2* CMR [Time frame: 30 days]
  • myocardial strain assessed by T2* CMR [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Blood transfusion within 30 days prior to CMR examination;
  • Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator;
  • Diagnosis of hemochromatosis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Hospital de Clínicas de Porto Alegre — Porto Alegre

Identifiers

NCT: NCT06434025 · 78861724.0.0000.5327 · 2023-0428

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗