Anemia in Patients With Endocarditis

NCT04840225 | Completed

• 1 other identifier: H-20044379
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anemia; Endocarditis, Bacterial

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  From time of diagnosis/intervention untill end of follow-up (up to 6 months from inclusion)

Study Arms (4)

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.

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.

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.

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

Other: Measurement of biomarkers for inflammation and anemia

Interventions

Measurement of biomarkers for inflammation and anemia OTHER

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

Endocarditis; Healthy blood donors; Patients with bacterial infections without endocarditis; TAVI/TEVAR patietns

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients with IE, 30 undergoing elective TAVI/TECAR, 30 with non-IE bacterial infections and 30 healthy blood donors

You may qualify if:

• Infectious endocarditis, defined by Duke criteria

You may not qualify if:

• Known rheumatic disease or immune defect
• TAVI/TEVAR patients:
• Scheduled for a TAVI/TEVAR procedure
• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples

MeSH Terms

Conditions

Anemia; Endocarditis, Bacterial

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Cardiovascular Infections; Cardiovascular Diseases; Endocarditis; Heart Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 9, 2021
• Study Start: March 22, 2021
• Primary Completion: March 29, 2023
• Study Completion: June 29, 2023
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

DK (1)