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

NCT05793996 | Recruiting Phase 4

• 1 other identifier: ID-HFpEF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency, Latent; Chronic Heart Failure

Keywords

HFpEF; iron deficiency; ferric carboxymaltose; Ferinject

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changing by 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ 0-100 points)

  6 months

• Changing in test distance with a 6-minute walk (6MWD 300 meters or more) of 35 meters

  6 months

• Changing functional class of chronic heart failure (CHF) by New York Heart Association (NYHA I-IV functional classes)

  6 months

• Hospitalization for heart failure and death from all causes

  12 months

• Changing by 5 or more points according to the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) (0-105 points).

  6 months

Study Arms (3)

Experimental: 1

ACTIVE COMPARATOR

Drug: Ferinject ® (Ferric carboxymaltose)

Drug: Ferinject

Comparison Group: 2

OTHER

Diet therapy, without drug therapy

Other: Diet therapy

Control Group: 3

NO INTERVENTION

Without therapy

Interventions

Ferinject DRUG

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.

Also known as: Ferric carboxymaltose

Experimental: 1

Diet therapy OTHER

Patients will receive diet therapy to correct latent iron deficiency

Comparison Group: 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

Tomsk, 634012, Russia

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferric carboxymaltose; Diet Therapy

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Alla A. Garganeeva, M.D.

  Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga V. Tukish, Ph.D.

CONTACT

+79069476343; olgatukish@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 31, 2023
• Study Start: April 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)