Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 1 | Active Comparator | Drug: Ferinject ® (Ferric carboxymaltose) |
|
| Comparison Group: 2 | Other | Diet therapy, without drug therapy |
|
| Control Group: 3 | No Intervention | Without therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga V. Tukish, Ph.D. | Contact | +79069476343 | olgatukish@yandex.ru |
| Name | Affiliation | Role |
|---|---|---|
| Alla A. Garganeeva, M.D. | Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences | Recruiting | Tomsk | 634012 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Diet therapy | Other | Patients will receive diet therapy to correct latent iron deficiency |
|
| 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. | 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. | 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. | 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. | 6 months |