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NCT Number: NCT05793996

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Tomsk, 634012, Russia

Location status: Recruiting

Location contact

Olga V. Tukish, Ph.D.

CONTACT

[email protected]

89069476343

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ferric carboxymaltose

Diet therapy

Other

Patients will receive diet therapy to correct latent iron deficiency

Primary outcomes

  1. Primary Outcome (Combined)

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Hospitalization for heart failure and death from all causes

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Olga V. Tukish, Ph.D.

CONTACT

[email protected]

+79069476343

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study 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

Acronym: ID-HFpEF

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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