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

Chronic Heart Failure Clinical Trial

— ID-HFpEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05793996
• Other study ID #: ID-HFpEF
• Status: Recruiting
• Phase: Phase 4
• Start date: April 28, 2023
• Est. completion date: December 2026

Study information

• Verified date: July 2023
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: Olga V. Tukish, Ph.D.
• Phone: +79069476343
• Email: olgatukish[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;
• ?nemia not related to iron deficiency;
• ?nemia 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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Chronic Heart Failure

Intervention

Drug:
• Ferinject
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.

Other:
• Diet therapy
Patients will receive diet therapy to correct latent iron deficiency

Locations

Country	Name	City	State
Russian Federation	Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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