Projects / Programmes
Epidemiology, patophysiology and clinical significance of iron deficiency in chronic cardiopulmonary disease
| Code |
Science |
Field |
Subfield |
| 3.06.00 |
Medical sciences |
Cardiovascular system |
|
| Code |
Science |
Field |
| B530 |
Biomedical sciences |
Cardiovascular system |
| Code |
Science |
Field |
| 3.02 |
Medical and Health Sciences |
Clinical medicine |
iron deficiency; heart failure; chronic obstructive pulmonary disease; epidemiology; pathophysiology; mortality
Researchers (8)
Organisations (3)
Abstract
Iron deficiency (ID) is one of the most common conditions in clinical medicine, with an estimated prevalence of 30%. Diagnostic criteria are partially disease dependent but most of associations and guidelines agree that absolute ID is defined as ferritin concentration (100 μg/L; transferrin saturation (TSAT (20%) is helpful for diagnosis of functional ID.
Heart failure (HF) guidelines specifically emphasize the role of comorbidities in heart failure, along with identification of gaps and need for future research. In patients with HF, most of information is available for heart failure with reduced ejection fraction (HFrEF), in whom the prevalence of ID is 30-50% (depends on patient characteristics and whether this is acute or chronic HF). ID is associated with reduced exercise capacity, poor quality of life and higher mortality. In HFrEF it is now known that reversal of functional ID using intravenous iron, namely ferric carboxymaltose, can lead to improved symptom status and exercise capacity both in patients with and without anaemia. In case of chronic obstructive pulmonary disease (COPD), guidelines are far less specific: anaemia is mentioned twice while ID is not mentioned at all.
This project aims to investigate ID in HFpEF, HFmrEF and in COPD; we will focus on prevalence and factors associated with ID. We will also investigate associations between patient characteristics, exercise capacity and quality of life. A detailed patient outcome analysis in terms of rehospitalisation and mortality will be performed. Finally, we will conduct two randomized trials of iron supplementation in HFpEF, HFmrEF and COPD to investigate effects of intravenous iron on quality of life and exercise capacity in HFpEF, HFmrEF and COPD.
Our project is a two-phase investigator initiated research.
First phase will primarily investigate ID prevalence and associations with outcomes (death, hospitalisation) in HFpEF, HFmrEF, and COPD. First phase will include retrospective and prospective study to investigate ID prevalence using established ID criteria: ferritin (100 μg/L OR ferritin 100-300 μg/L and transferrin saturation (20%) with or without anaemia (haemoglobin (130g/L in men or (120 g/L in women). We will review hospital records for ID in HFpEF, HFmrEF, and COPD (retrospective analysis, 2010-2018). Patient data will be cross-linked with central population registry to study associations with mortality. Simultaneously, we are conducting a prospective study of iron stores and complete blood count in HFpEF, HFmrEF, and COPD (prospective study, 2014-2019). All patients will be assessed for cardiac function and measurement of ejection fraction, markers of anaemia and iron status. When indicated and feasible, we will also evaluate exercise capacity (6-minute walk test, exercise testing), quality of life and patient related outcomes (hospitalizations, mortality).
In first phase, primary endpoint will be ID; secondary endpoints will be exercise capacity, mortality and hospitalizations. Patient follow-up will be at least 12 months.
Second phase will investigate ID pathophysiology and the effects of intravenous iron supplementation on quality of life and exercise capacity.
In second phase, two randomized, double blind, placebo controlled trials of intravenous iron supplementation will be conducted (patients with HfpEF, HFmrEF, and patients with COPD). In second phase primary endpoints will be change in quality of life (EQ-5D) and change in maximal oxygen consumption (treadmill); secondary endpoints will be change in 6-minute walk test, NYHA class, laboratory markers of iron stores and haemoglobin.
Results of this project are expected to contribute significantly to our understanding of ID in patients with HF and COPD. We will be among first to report about epidemiology in HFmrEF from a large database; our sample will also be significant in terms of bone marrow analysis. In patients with COPD, this is one of first interventional studies with iron suppleme
Significance for science
In patients with chronic disease we need to assess comorbidities to manage symptoms and the overall disease burden. This is even more important in patients who remain symptomatic despite optimal management of main chronic disease. ID, with or without anaemia, is an important comorbidity that needs to be diagnosed timely and managed in a proper way, as it can significantly improve patient clinical status and outcome.
In view of limited literature, our findings will contribute importantly to current knowledge in the field and have a significant potential to change patient management. Key issues of our project are prevalence of ID and effects of intravenous iron supplementation on quality of life and exercise capacity in HFpEF, HFmrEF, and COPD.
Our project will address these issues in an innovative way, and will be pioneering contribution to several topics in the field of iron deficiency. We also expect our findings will influence clinical practice and management of patients with body wasting.
Significance for the country
In patients with chronic disease we need to assess comorbidities to manage symptoms and the overall disease burden. This is even more important in patients who remain symptomatic despite optimal management of main chronic disease. ID, with or without anaemia, is an important comorbidity that needs to be diagnosed timely and managed in a proper way, as it can significantly improve patient clinical status and outcome.
In view of limited literature, our findings will contribute importantly to current knowledge in the field and have a significant potential to change patient management. Key issues of our project are prevalence of ID and effects of intravenous iron supplementation on quality of life and exercise capacity in HFpEF, HFmrEF, and COPD.
Our project will address these issues in an innovative way, and will be pioneering contribution to several topics in the field of iron deficiency. We also expect our findings will influence clinical practice and management of patients with body wasting.
Most important scientific results
Interim report
Most important socioeconomically and culturally relevant results
Interim report
