AnemiaANIENCT04840225
Anemia in Patients With Endocarditis
An observational study of Anemia and Endocarditis, Bacterial, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Prospective study of prevalence and deep charecterization of anemia in patients with endocarditis from diagnosis undtill 6 months after discharge. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia, Endocarditis, Bacterial
- What is being tested?
- Measurement of biomarkers for inflammation and anemia
- How many people
- 209 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Mar 2021to 29 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 patients with IE, 30 undergoing elective TAVI/TECAR, 30 with non-IE bacterial infections and 30 healthy blood donors
Who may be able to join
- Infectious endocarditis, defined by Duke criteria
- Scheduled for a TAVI/TEVAR procedure
- Patients admitted with an infection with gram positive bacteria, without IE Exclusion criteria
- Known rheumatic disease or immune defect
- Blood donors:
Who cannot join
- 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):
- Antibiotic treatment within the last 2 months
Show all 9Show fewer
- Cancer, rheumatic disease or other known inflammatory disease
- Surgery within the last 3 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anæmi Hos Patienter Med infektiøs Endokarditis - Karakteristik og Mekanismer (ANIE)
Prospective study of prevalence and deep charecterization of anemia in patients with endocarditis from diagnosis undtill 6 months after discharge.
Read the 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
- Being tested
- Measurement of biomarkers for inflammation and anemia
- Medical subject headings
- Anemia, Endocarditis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of biomarkers for inflammation and anemiaOther
Measurement of biomarkers for inflammation and anemia, in addition to standart clinical measurements
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Measurement of biomarkers for inflammation and anemia | |
| 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. Receives: Other: Measurement of biomarkers for inflammation and anemia | |
| 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. Receives: Other: Measurement of biomarkers for inflammation and anemia | |
| 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 Receives: Other: Measurement of biomarkers for inflammation and anemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anemia during hospitalization
Diagnosis of anemia through WHO/NCI criteria for anemia and severity of anemia at time of diagnosis, 1-4 weeks after initiation of relevant treatment and up to 6 months after discharge
Measured: From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)
Secondary outcomes (3)
Prevalence of iron deficiency anemia in patients with IE and relevant controls
Determination of the prevalence of iron deficiency anemia through measurements of hemoglobin, markers of anemia and of iron metabolism/stores in blood
Measured: From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)
Prevalence of anemia due to inflammation in patients with IE and relevant controls
Determination of the prevalence of anemia og inflammation through measurements of markers of anemia of inflammation (IL-6 hepcidin, erytroferrone, soluble transferrin receptor)
Measured: From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)
Time untill resolution of inflammation and anemia in patients with IE and relevant controls
Determination of time from start of treatment/intervention until normalization of markers of inflammation and anemia, as well as normalization of erythropoiesis
Measured: From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start22 Mar 2021
- Primary completion29 Mar 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mia Pries-Heje, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840225
- Sponsor's protocol ID
- H-20044379
- Acronym
- ANIE
- Status last verified
- Sep 2025
- First submitted
- 29 Mar 2021
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anæmi Hos Patienter Med infektiøs Endokarditis - Karakteristik og Mekanismer (ANIE)
- ClinicalTrials.gov ID
- NCT04840225
- Acronym / sponsor ID
- ANIE / H-20044379
- Conditions
- Anemia, Endocarditis, Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Endocarditis | – | Other: Measurement of biomarkers for inflammation and anemia100 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. |
| TAVI/TEVAR patietns | – | Other: Measurement of biomarkers for inflammation and anemia30 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. |
| Patients with bacterial infections without endocarditis | – | Other: Measurement of biomarkers for inflammation and anemia30 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. |
| Healthy blood donors | – | Other: Measurement of biomarkers for inflammation and anemiaDetailed 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with IE, 30 undergoing elective TAVI/TECAR, 30 with non-IE bacterial infections and 30 healthy blood donors
Key inclusion criteria (5 listed)
- Infectious endocarditis, defined by Duke criteria
- Scheduled for a TAVI/TEVAR procedure
- Patients admitted with an infection with gram positive bacteria, without IE Exclusion criteria
- Known rheumatic disease or immune defect
Key exclusion criteria (9 listed)
- Known rheumatic disease or immune defect
- Clinical suspicion of infection
- Known rheumatic disease or immune defect
- Antibiotic treatment within the last 2 months
- Cancer, rheumatic disease or other known inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of biomarkers for inflammation and anemiaMeasurement of biomarkers for inflammation and anemia, in addition to standart clinical measurements | Other | Endocarditis, Healthy blood donors, Patients with bacterial infections without endocarditis, TAVI/TEVAR patietns |
Primary outcome
Prevalence of anemia during hospitalization
Time frame: From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)
Diagnosis of anemia through WHO/NCI criteria for anemia and severity of anemia at time of diagnosis, 1-4 weeks after initiation of relevant treatment and up to 6 months after discharge
3 secondary outcomes
Prevalence of iron deficiency anemia in patients with IE and relevant controls
Time frame: From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)
Prevalence of anemia due to inflammation in patients with IE and relevant controls
Time frame: From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)
Time untill resolution of inflammation and anemia in patients with IE and relevant controls
Time frame: From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: Undecided. Available on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Endocarditis, Bacterial, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anemia during hospitalization (time frame: From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.