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RecruitingNCT04992923EIPSLUpdated Nov 21, 2025

Prospective Cohort Study of Patients With Infective Endocarditis at Pitié-Salpêtrière Hospital

An observational study in Infective Endocarditis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Started Sep 2020; still recruiting 6 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
18 Years and older
Sex
All
01

Study summary

Infective endocarditis (IE) is a severe condition associated with high mortality. Due to the relative low prevalence of IE, prospective data are lacking and current guidelines are mostly based on expert consensus with low level of evidence. IE is also associated with severe complications especially strokes that occur in about one third of the patients.

In order to improve the management and the prognosis of IE, clinical data from larges prospective cohort studies are needed.

Read the detailed description

The study will take place at the Cardiology institute of the Pitié-Salpêtrière hospital. All patients referred to this tertiary care center for IE management will be included.

The characteristics of the patients (demographics, clinical, laboratory, and imaging data) at the time of IE diagnosis and during the follow-up will be collected. The patients will be followed up to 10 years after inclusion.

02

Conditions studied

  • Infective Endocarditis

Keywords

  • Infective endocarditis, prospective,
  • prognosis, biomarker, embolism
03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's planned enrollment of 700 is above the median of 225 across 82 observational studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All the patients with IE admitted at Cardiology institute of the Pitié-Salpêtrière hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with confirmed IE according to European Society of Cardiology criteria

Exclusion criteria

Exclusion Criteria:

  • Opposition of the patient to participate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. All-cause in hospital mortality

    All-cause mortality during the length of hospital stay

    Time frame: up to 90 days

Secondary outcomes

  1. All-cause mortality

    mortality at longest follow-up

    Time frame: an average of 10 years

  2. symptomatic or asymptomatic systemic embolism

    symptomatic or asymptomatic systemic embolism confirmed by any type of imaging during initial hospitalization

    Time frame: up to 90 days after inclusion

  3. Association between coagulation biomarkers (D-dimer, fibrin monomer, circulating anticoagulant, von Willebrandt factor (VWF) antigen level, von Willebrandt factor (VWF) activity) assessed at the inclusion and the presence of systemic embolism

    Association between coagulation biomarkers (D-dimer, fibrin monomer, circulating anticoagulant, von Willebrandt factor (VWF) antigen level, von Willebrandt factor (VWF) activity) assessed at the inclusion and the presence of systemic embolism at the admission Initial Hospitalization

    Time frame: inclusion

  4. Association between coagulation biomarkers (D-dimer, fibrin monomer, circulating anticoagulant, von Willebrandt factor (VWF) antigen level, von Willebrandt factor (VWF) activity) assessed at the inclusion and the presence of systemic embolism

    Association between coagulation biomarkers(D-dimer, fibrin monomer, circulating anticoagulant, von Willebrandt factor (VWF) antigen level, von Willebrandt factor (VWF) activity) assessed at the inclusion and the presence of systemic embolism within 90 days after admission

    Time frame: up to 90 days after inclusion

  5. heart failure, intracranial hemorrhage, or false vascular aneurysm during hospitalization

    Occurrence of heart failure, intracranial hemorrhage, or false vascular aneurysm during the length of hospital stay

    Time frame: up to 90 days after inclusion

  6. Stroke

    Stroke during the length of hospital stay

    Time frame: 90 days after inclusion

  7. composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence

    Occurrence of a composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence at one year

    Time frame: 1 year after inclusion

  8. composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence

    Occurrence of a composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence at the longest follow-up

    Time frame: through study completion, an average of 10 years

  9. composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3

    on-year composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3

    Time frame: 1 year after inclusion

  10. composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3

    Occurrence of a composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3 at the longest follow-up

    Time frame: through study completion, an average of 10 years

  11. Association between occurrence of systemic embolism and the composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3

    Association between occurrence of systemic embolism and the composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3 at one year

    Time frame: 1 year after inclusion

  12. Occurrence of contrast-associated acute kidney injury during the length of hospital stay

    rise of serum creatinine \> 26.5 mcmol/L or \> 50% elevation from baseline over the course of hospitalization

    Time frame: up to 90 days after inclusion

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2020 (actual). Primary completion is estimated for Sep 2040, 240 months after the start.

Of 36 observational studies under Endocarditis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 36. This study's planned 240 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2020
First posted
Aug 5, 2021
StartActual
Sep 15, 2020
Primary completionEst.
Sep 2040
CompletionEst.
Mar 2041
Last update
Nov 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04992923
Responsible party
Sponsor
First posted
Aug 5, 2021
Start date
Sep 15, 2020
Primary completion
Sep 2040 (estimated)
Completion
Mar 2041 (estimated)
Last update
Nov 21, 2025

Study contacts

Nadjib Hammoudi, MD, PhD
Contact
nadjib.hammoudi@aphp.fr
+33 142165535
Nadjib Hammoudi, MD, PhD
principal investigator · Pitié-Salpêtrière Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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