The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Experimental: 1 Drug: Ferinject ® (Ferric carboxymaltose) |
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 Names:
|
| Other: Comparison Group: 2 Diet therapy, without drug therapy |
Other: Diet therapy
Patients will receive diet therapy to correct latent iron deficiency
|
| No Intervention: Control Group: 3 Without therapy |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
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 (in women >120 g/l, in men >130 g/l).
Exclusion Criteria:
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Uncontrolled arterial hypertension;
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Anemia;
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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;
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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);
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Known active infection, clinically significant bleeding, active malignancy;
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Severe autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.);
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences | Tomsk | Russian Federation | 634012 |
Sponsors and Collaborators
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Investigators
- Principal Investigator: Alla A. Garganeeva, M.D., Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ID-HFpEF