Trials / Recruiting
RecruitingNCT05793996
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | Diet therapy | Patients will receive diet therapy to correct latent iron deficiency |
Timeline
- Start date
- 2023-04-28
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2023-03-31
- Last updated
- 2025-12-16
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT05793996. Inclusion in this directory is not an endorsement.