Chronic Heart FailurePhase 4ID-HFpEFNCT05793996
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
A Phase 4 study testing Ferinject and Diet therapy in people with Chronic Heart Failure and Iron Deficiency, Latent, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Iron Deficiency, Latent
- What is being tested?
- Ferinject and Diet therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 28 Apr 2023to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, 634012
Olga V. Tukish, Ph.D., 89069476343, olgatukish@yandex.ru
About this study
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
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.
Read the 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).
- Conditions
- Chronic Heart Failure, Iron Deficiency, Latent
- Being tested
- Ferinject, Diet therapy
- Keywords
- HFpEF, iron deficiency, ferric carboxymaltose, Ferinject
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerinjectDrug
Also called Ferric carboxymaltose
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.
Diet therapyOther
Patients will receive diet therapy to correct latent iron deficiency
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 1 | Active comparator | Drug: Ferinject ® (Ferric carboxymaltose) Receives: Drug: Ferinject |
| Comparison Group: 2 | Other | Diet therapy, without drug therapy Receives: Other: Diet therapy |
| Control Group: 3 | No intervention | Without therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start28 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alla A. Garganeeva, M.D., Principal investigator, Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793996
- Sponsor's protocol ID
- CRI-243
- Acronym
- ID-HFpEF
- Status last verified
- Jun 2026
- First submitted
- 1 Mar 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05793996
- Acronym / sponsor ID
- ID-HFpEF / CRI-243
- Conditions
- Chronic Heart Failure, Iron Deficiency, Latent
- Keywords
- HFpEF, iron deficiency, ferric carboxymaltose, Ferinject
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: 1 | Active comparator | Drug: FerinjectDrug: Ferinject ® (Ferric carboxymaltose) |
| Comparison Group: 2 | Other | Other: Diet therapyDiet therapy, without drug therapy |
| Control Group: 3 | No intervention | –Without therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerinjectAlso: Ferric carboxymaltoseThe 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. | Drug | Experimental: 1 |
| Diet therapyPatients will receive diet therapy to correct latent iron deficiency | Other | Comparison Group: 2 |
Primary outcome
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.
5 secondary outcomes
Changing by 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ 0-100 points)
Time frame: 6 months
Changing in test distance with a 6-minute walk (6MWD 300 meters or more) of 35 meters
Time frame: 6 months
Changing functional class of chronic heart failure (CHF) by New York Heart Association (NYHA I-IV functional classes)
Time frame: 6 months
Hospitalization for heart failure and death from all causes
Time frame: 12 months
Changing by 5 or more points according to the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) (0-105 points).
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alla A. Garganeeva, M.D. principal investigator
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferinject and Diet therapy in people with Chronic Heart Failure and Iron Deficiency, Latent, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olga V. Tukish, Ph.D. (+79069476343, olgatukish@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (Combined) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.