Heart Failure, Systolic Clinical Trial
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.
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT03227393 -
The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
|
N/A | |
Recruiting |
NCT04528004 -
Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure
|
Early Phase 1 | |
Recruiting |
NCT04703842 -
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
|
Phase 1/Phase 2 | |
Recruiting |
NCT04522609 -
Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant
|
N/A | |
Completed |
NCT05475028 -
Network Medicine Approaches to Classify Heart Failure With PReserved Ejection Fraction by Signatures of DNA Methylation and Point-of-carE Risk calculaTors (PRESMET)
|
||
Not yet recruiting |
NCT06240403 -
Digoxin and Senolysis in Heart Failure and Diabetes Mellitus
|
Phase 2 | |
Not yet recruiting |
NCT05988749 -
Digital Remote Home Monitoring for Heart Failure
|
N/A | |
Recruiting |
NCT04950218 -
The Psoriasis Echo Study
|
||
Suspended |
NCT04701112 -
Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure
|
N/A | |
Completed |
NCT03305692 -
ECG Belt vs. Echocardiographic Optimization of CRT
|
N/A | |
Recruiting |
NCT05933083 -
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
|
N/A | |
Enrolling by invitation |
NCT03903107 -
The Fluoroless-CSP Trial Using Electroanatomic Mapping
|
N/A | |
Withdrawn |
NCT04872959 -
TRANSFORM Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT02920918 -
Treatment of Diabetes in Patients With Systolic Heart Failure
|
Phase 4 | |
Completed |
NCT02334891 -
Kyoto Congestive Heart Failure Study
|
||
Recruiting |
NCT03553303 -
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin
|
Phase 4 | |
Recruiting |
NCT04083690 -
Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients
|
N/A | |
Recruiting |
NCT03830957 -
Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
|
N/A | |
Recruiting |
NCT06121323 -
Physiological Effects of Lactate in Individuals With Chronic Heart Failure
|
N/A | |
Completed |
NCT03351283 -
Effect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure
|
N/A |