The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)

Study Overview
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Brief Summary
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Observational cohort randomized controlled study to study the influence of correction of ID by intravenous injection of ferric carboxymaltose (Ferinject®) on quality of life indicators, functional status in a cohort of patients with HFpEF.

Detailed Description
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The prevalence of HFpEF among patients admitted to cardiology hospitals will be studied. The study will include patients with NYHA II-III who have signed an informed consent that meets the inclusion/exclusion criteria. The effectiveness of intravenous administration of iron carboxymaltose (Ferinject ® ) to correct iron deficiency and improve the clinical course of HFpEF will be evaluated. A group without iron deficiency will be recruited as a control group (n=30).

Official Title
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Study of the Prevalence of Iron Deficiency Among Hospitalized Patients With HFpEF and the Impact of Ferinject® on Indicators of Quality of Life, Functional Status in Patients With Iron Deficiency

Conditions
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Chronic Heart Failure, Iron Deficiency, Latent

Intervention / Treatment
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* Drug: Ferinject
* Other: Diet therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent to participate in the study; In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF); Left ventricular ejection fraction (LVEF) ≥50%; objective signs of structural and/or functional disorders of the heart consistent with the presence of LV diastolic dysfunction/increased LV filling pressure, including elevated levels of natriuretic peptide; Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%; Screening haemoglobin (Hb) at the time of switching on ( 90-150 g/l). Exclusion Criteria: Uncontrolled arterial hypertension; Аnemia not related to iron deficiency; Аnemia with a hemoglobin level of less than 90 g/l; Less than 1 year after acute myocardial infarction; Less than 1 year after acute cerebral circulation disorder; Less than 1 year after surgical interventions, including non-cardiac operations and myocardial revascularization (coronary bypass surgery, coronary artery stenting), operations for valvular pathology; Chronic alcoholism (including alcoholic heart disease), mental disorders; Severe hepatic (increased transaminase levels above the upper three limits of normal) and renal insufficiency (glomerular filtration rate less than 15 ml/min/1.73 m2); Known active infection, clinically significant bleeding, active malignancy; Severe autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.); Severe bronchial asthma, COPD in the acute stage; Allergic reactions to medications in the anamnesis, eczema, atopic allergic reaction; Blood transfusions and taking erythropoiesis-stimulating drugs during the previous three months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental: 1<br>Drug: Ferinject ® (Ferric carboxymaltose) | Drug: Ferinject<br>* The calculation of the dose of iron carboxymaltosate (Ferinject ® preparation) for the purpose of correction of iron will be carried out on the basis of the following step-by-step approach: determination of individual iron needs, calculation and administration of iron dose, assessment of the saturation of the patient's body with iron 6 weeks after infusion.<br>* Other names: Ferric carboxymaltose;|
| Other: Comparison Group: 2<br>Diet therapy, without drug therapy | Other: Diet therapy<br>* Patients will receive diet therapy to correct latent iron deficiency<br>|
| No Intervention: Control Group: 3<br>Without therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome (Combined) | Change of 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ) (0-100 points)+change in test distance with a 6-minute walk (6MWD - 150 meters or more) by 35 meters or more. An increase in the number of points by 5 on the Kansas City Cardiomyopathy Questionnaire scale, increasing the distance on the 6-minute walk test by 35 meters means a better result. The absence of changes/decrease in the number of points on the Kansas City Cardiomyopathy Questionnaire scale, the absence of changes/decrease in the distance in the 6-minute walking test means the worst result. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing by 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ 0-100 points) | Change of 5 or more points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) (0-100 points). An increase in the number of points by 5 on the Kansas City Cardiomyopathy Questionnaire scale means a better result. The absence of changes/decrease in the number of points on the Kansas City Cardiomyopathy Questionnaire scale means the worst result. | 6 months | 
| Changing in test distance with a 6-minute walk (6MWD 300 meters or more) of 35 meters | Change in the distance when testing a 6-minute walk by 35 meters or more. An increase the distance on the 6-minute walk test by 35 meters or more means a better result. The absence of changes/decrease in the distance in the 6-minute walking test means the worst result. | 6 months | 
| Changing functional class of chronic heart failure (CHF) by New York Heart Association (NYHA I-IV functional classes) | Reduction of the functional class of CHF according to New York Heart Association by 1point means a better result. No changes or an increase in the functional class means a worse result. | 6 months | 
| Hospitalization for heart failure and death from all causes | The absence of hospitalizations for heart failure and death from all causes means a better result. Hospitalization and death from all causes means the worst result. | 12 months | 
| Changing by 5 or more points according to the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) (0-105 points). | A decrease of 5 or more points on the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) means a better result. The absence of changes/increase in the number of points on the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) means the worst result. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFpEF, iron deficiency, ferric carboxymaltose, Ferinject