Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434025
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-23
Brief Title:
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
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMBINED-HF
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-0428 | OTHER | AGH-Use HCPA | None |