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

Sponsor
Hospital de Clinicas de Porto Alegre
Study ID
NCT06434025
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Heart Failure, Systolic
  • Iron Deficiencies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
May 24, 2024
Status verified
May 2024
Primary completion
May 24, 2026
Completion
Nov 24, 2026

Study Design

Enrollment
99 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ferric carboxymaltose + SGLT2 inhibitor
    Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and Dapagliflozin 10 mg PO, once a day, for 30 days.
  • Active Comparator: ferric carboxymaltose + placebo of SGLT2 inhibitor
    Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and placebo PO, once a day, for 30 days.
  • Placebo Comparator: Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor
    Patients will receive 2 vials of placebo IV, once; and placebo PO, once a day, for 30 days.

Primary Outcome Measure

left ventricular function assessed (LVEF) by CMR. [ Time Frame: 30 days ]

Central Contacts

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