Anemia in Patients With Endocarditis

NCT ID: NCT04840225

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 209 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2023-06-29

Brief Summary

Prospective study of prevalence and deep charecterization of anemia in patients with endocarditis from diagnosis undtill 6 months after discharge.

Detailed Description

Anemia is an adverse prognostic marker in both cardiac diseases and infectious diseases. In patients with bacterial endocarditis (IE), anemia has a prevalence of 55-80%. In a sub-study to our POET I trial (RCT with 400 patients with IE, published in NEJM 2019), preliminary data show a 5-fold increased risk of death within 6 months and 2-fold increased risk after 3 years, in non-surgically treated patients with hemoglobin <6.2mmol/L, compared to patients with no or mild anemia. Intensified treatment of anemia through e.g. intravenous iron infusions, in combination with erythrocyte stimulating agents or new treatments for anemia of inflammation, such as IL-6 inhibitors, could possibly improve outcome for patients with IE.

This study - ANIE - is a prospective study, aiming at further deep-characterizing of anemia in patients with IE, and associated outcomes. Degree of anemia of inflammation (AI) and iron-deficiency anemia during hospitalization and time to recovery will be assessed. Blood samples from 100 patients with IE will be collected during hospitalization and 3 months after discharge, i.e. also during expected recovery. Samples will be analyzed for standard markers of anemia and inflammation, as well as novel biomarkers for AI, such as IL-6, soluble transferrin receptor, erythroferrone and hepcidin. The sample size calculation is based on the assumption that the prevalence of AI is 50%, with a confidence interval of 95% and a margin of error of <10%. Comparisons will be made to patients with other infections and patients with pure inflammation (TAVI and TEVAR patients) and healthy blood donors.

ANIE is expected to give us an unprecedented insight into disease processes, stages and possible therapeutic targets for anemia in patients with IE.

The results will serve for designing the clinical trial of novel interventions to treat anemia in patients with IE, as a novel means to improve the outcome and reduce the high mortality in these patients.

Anemia is an adverse prognostic marker in both cardiac diseases and infectious diseases. In patients with bacterial endocarditis (IE), anemia has a prevalence of 55-80%. In a sub-study to our POET I trial (RCT with 400 patients with IE, published in NEJM 2019), preliminary data show a 5-fold increased risk of death within 6 months and 2-fold increased risk after 3 years, in non-surgically treated patients with hemoglobin <6.2mmol/L, compared to patients with no or mild anemia. Intensified treatment of anemia through e.g. intravenous iron infusions, in combination with erythrocyte stimulating agents or new treatments for anemia of inflammation, such as IL-6 inhibitors, could possibly improve outcome for patients with IE.

This study - ANIE - is a prospective study, aiming at further deep-characterizing of anemia in patients with IE, and associated outcomes. Degree of anemia of inflammation (AI) and iron-deficiency anemia during hospitalization and time to recovery will be assessed. Blood samples from 100 patients with IE will be collected during hospitalization and 3 months after discharge, i.e. also during expected recovery. Samples will be analyzed for standard markers of anemia and inflammation, as well as novel biomarkers for AI, such as IL-6, soluble transferrin receptor, erythroferrone and hepcidin. The sample size calculation is based on the assumption that the prevalence of AI is 50%, with a confidence interval of 95% and a margin of error of <10%. Comparisons will be made to patients with other infections and patients with pure inflammation (TAVI and TEVAR patients) and healthy blood donors.

ANIE is expected to give us an unprecedented insight into disease processes, stages and possible therapeutic targets for anemia in patients with IE.

The results will serve for designing the clinical trial of novel interventions to treat anemia in patients with IE, as a novel means to improve the outcome and reduce the high mortality in these patients.

Conditions

Anemia; Endocarditis, Bacterial

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Endocarditis

100 patients diagnosed with infectious endocarditis according to DUKE criteria. Detailed characterization of inflammation, anemia and markers of iron hemostatis will be made at diagnosis and followed undtill 6 months after discharge.

Measurement of biomarkers for inflammation and anemia

Intervention Type: OTHER

Measurement of biomarkers for inflammation and anemia, in addition to standart clinical measurements

TAVI/TEVAR patietns

30 patients undergoing elektive TAVI/TEVAR procedures. Detailed characterization of inflammation, anemia and markers of iron hemostatis will be made at directly prior to procedure and followed undtill 3 months after discharge.

Measurement of biomarkers for inflammation and anemia

Intervention Type: OTHER

Measurement of biomarkers for inflammation and anemia, in addition to standart clinical measurements

Patients with bacterial infections without endocarditis

30 patients diagnosed with with bacterial infections, without endocarditis. Detailed characterization of inflammation, anemia and markers of iron hemostatis will be made at diagnosis and followed undtill 3 months after discharge.

Measurement of biomarkers for inflammation and anemia

Intervention Type: OTHER

Measurement of biomarkers for inflammation and anemia, in addition to standart clinical measurements

Healthy blood donors

Detailed characterization of inflammation, anemia and markers of iron hemostatis will be made at directly prior to blood donation and approximately 1 week after blood donations

Measurement of biomarkers for inflammation and anemia

Intervention Type: OTHER

Measurement of biomarkers for inflammation and anemia, in addition to standart clinical measurements

Interventions

Measurement of biomarkers for inflammation and anemia

Measurement of biomarkers for inflammation and anemia, in addition to standart clinical measurements

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Infectious endocarditis, defined by Duke criteria

• Scheduled for a TAVI/TEVAR procedure

Exclusion Criteria

• Known rheumatic disease or immune defect

TAVI/TEVAR patients:

• Clinical suspicion of infection
• Known rheumatic disease or immune defect

Bacterial patients without IE (short infection):

• Known rheumatic disease or immune defect

Blood donors:

• Antibiotic treatment within the last 2 months
• Cancer, rheumatic disease or other known inflammatory disease
• Surgery within the last 3 months
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Mia Pries-Heje

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-20044379

Identifier Type: -

Identifier Source: org_study_id