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

Phase 4

Recruiting

• Conditions: Iron Deficiency, Latent; Chronic Heart Failure
• Interventions: Other: Diet therapy; Drug: Ferinject

• Registration Number: NCT05793996
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-03-31
• Study Start: 2023-04-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison Group: 2	Diet therapy	Diet therapy, without drug therapy
Experimental: 1	Ferinject	Drug: Ferinject ® (Ferric carboxymaltose)

Primary Outcome Measures

Name	Time	Method
Primary Outcome (Combined)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Hospitalization for heart failure and death from all causes	12 months	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.
Changing by 5 or more points according to the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) (0-105 points).	6 months	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.
Changing in test distance with a 6-minute walk (6MWD 300 meters or more) of 35 meters	6 months	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.
Changing functional class of chronic heart failure (CHF) by New York Heart Association (NYHA I-IV functional classes)	6 months	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.
Changing by 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ 0-100 points)	6 months	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.

Trial Locations

Locations (1)

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences; 🇷🇺 Tomsk, Russian Federation