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

NCT06434025 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2024-06-03

No results posted yet for this study

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.

Conditions

  • Heart Failure, Systolic
  • Iron Deficiencies

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

Sponsors & Collaborators

  • Vifor Pharma

    collaborator INDUSTRY

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • LUIS BECK DA SILVA, MD ScD · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-24
Primary Completion
2026-05-24
Completion
2026-11-24

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06434025 on ClinicalTrials.gov