Back to resultsThe Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF) (ID-HFpEF)
Primary Purpose
Chronic Heart Failure, Iron Deficiency, Latent
Status
Recruiting
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Ferinject
Diet therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring HFpEF, iron deficiency, ferric carboxymaltose, Ferinject
Eligibility 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 ( 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.
Sites / Locations
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Other
No Intervention
Arm Label
Experimental: 1
Comparison Group: 2
Control Group: 3
Arm Description
Drug: Ferinject ® (Ferric carboxymaltose)
Diet therapy, without drug therapy
Without therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05793996
First Posted
March 1, 2023
Last Updated
July 28, 2023
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05793996
Brief Title
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
Acronym
ID-HFpEF
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Iron Deficiency, Latent
Keywords
HFpEF, iron deficiency, ferric carboxymaltose, Ferinject
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: 1
Arm Type
Active Comparator
Arm Description
Drug: Ferinject ® (Ferric carboxymaltose)
Arm Title
Comparison Group: 2
Arm Type
Other
Arm Description
Diet therapy, without drug therapy
Arm Title
Control Group: 3
Arm Type
No Intervention
Arm Description
Without therapy
Intervention Type
Drug
Intervention Name(s)
Ferinject
Other Intervention Name(s)
Ferric carboxymaltose
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Diet therapy
Intervention Description
Patients will receive diet therapy to correct latent iron deficiency
Primary Outcome Measure Information:
Title
Primary Outcome (Combined)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changing by 5 or more points on the Kansas City Cardiomyopathy Questionnaire (KCCQ 0-100 points)
Description
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.
Time Frame
6 months
Title
Changing in test distance with a 6-minute walk (6MWD 300 meters or more) of 35 meters
Description
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.
Time Frame
6 months
Title
Changing functional class of chronic heart failure (CHF) by New York Heart Association (NYHA I-IV functional classes)
Description
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.
Time Frame
6 months
Title
Hospitalization for heart failure and death from all causes
Description
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.
Time Frame
12 months
Title
Changing by 5 or more points according to the Minnesota Heart Failure Quality of Life Questionnaire (MHFLQ) (0-105 points).
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 ( 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga V. Tukish, Ph.D.
Phone
+79069476343
Email
olgatukish@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alla A. Garganeeva, M.D.
Organizational Affiliation
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga V. Tukish, Ph.D.
Phone
89069476343
Email
olgatukish@yandex.ru
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
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