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Anemia in Patients With Endocarditis (ANIE)

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ClinicalTrials.gov Identifier: NCT04840225
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Mia Pries-Heje, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment
Anemia Endocarditis, Bacterial Other: Measurement of biomarkers for inflammation and anemia

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Study Type : Observational
Estimated Enrollment : 190 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Anæmi Hos Patienter Med infektiøs Endokarditis - Karakteristik og Mekanismer (ANIE)
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Endocarditis

Group/Cohort Intervention/treatment
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
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.
Other: Measurement of biomarkers for inflammation and anemia
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.
Other: Measurement of biomarkers for inflammation and anemia
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
Other: Measurement of biomarkers for inflammation and anemia
Measurement of biomarkers for inflammation and anemia, in addition to standart clinical measurements




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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) ]
    Determination of the prevalence of iron deficiency anemia through measurements of hemoglobin, markers of anemia and of iron metabolism/stores in blood

  2. 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) ]
    Determination of the prevalence of anemia og inflammation through measurements of markers of anemia of inflammation (IL-6 hepcidin, erytroferrone, soluble transferrin receptor)

  3. 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) ]
    Determination of time from start of treatment/intervention until normalization of markers of inflammation and anemia, as well as normalization of erythropoiesis


Biospecimen Retention:   Samples Without DNA
Serum and plasma samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

IE-patients:

Inclusion Criteria:

• Infectious endocarditis, defined by Duke criteria

Exclusion Criteria:

• Known rheumatic disease or immune defect

TAVI/TEVAR patients:

Inclusion Criteria:

• Scheduled for a TAVI/TEVAR procedure

Exclusion criteria:

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

Bacterial patients without IE (short infection):

Inclusion criteria

  • Patients admitted with an infection with gram positive bacteria, without IE Exclusion criteria
  • Known rheumatic disease or immune defect

Blood donors:

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840225


Contacts
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Contact: Mia Marie Pries-Heje, MD +45 35454245 mia.marie.pries-heje.01@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Mia Marie Pries-Heje    +4535454245      
Sponsors and Collaborators
Rigshospitalet, Denmark
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Responsible Party: Mia Pries-Heje, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04840225    
Other Study ID Numbers: H-20044379
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Available on reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis
Anemia
Hematologic Diseases
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection