Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, 634012, Russia
Location status: Recruiting
NCT Number: NCT05793996
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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Request Info18 year and older
All sexes
Interventional
Phase 4
Tomsk, 634012, Russia
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Patients will receive diet therapy to correct latent iron deficiency
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Tomsk National Research Medical Center of the Russian Academy of Sciences
Other
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
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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