Infective EndocarditisEIPSLNCT04992923
Prospective Cohort Study of Patients With Infective Endocarditis at Pitié-Salpêtrière Hospital
An observational study of Infective Endocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2020to Mar 2041
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All the patients with IE admitted at Cardiology institute of the Pitié-Salpêtrière hospital
Who may be able to join
- Patients with confirmed IE according to European Society of Cardiology criteria
Who cannot join
- Opposition of the patient to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
APHP Pitié-Salpêtrière Hospital, Department of Cardiology
Paris, 75013
Nadjib Hammoudi, MD, PhD, +33 142165535, nadjib.hammoudi@aphp.fr
About this study
Official title: Prospective Cohort Study of Patients With Infective Endocarditis Admitted at Cardiology Institute of Pitié-Salpêtrière Hospital
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.
- Conditions
- Infective Endocarditis
- Keywords
- Infective endocarditis, prospective,, prognosis, biomarker, embolism
- Medical subject headings
- Endocarditis, Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause in hospital mortality
All-cause mortality during the length of hospital stay
Measured: up to 90 days
Secondary outcomes (12)
All-cause mortality
mortality at longest follow-up
Measured: an average of 10 years
symptomatic or asymptomatic systemic embolism
symptomatic or asymptomatic systemic embolism confirmed by any type of imaging during initial hospitalization
Measured: up to 90 days after inclusion
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
Measured: inclusion
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
Measured: up to 90 days after inclusion
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
Measured: up to 90 days after inclusion
Stroke
Stroke during the length of hospital stay
Measured: 90 days after inclusion
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
Measured: 1 year after inclusion
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
Measured: through study completion, an average of 10 years
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
Measured: 1 year after inclusion
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
Measured: through study completion, an average of 10 years
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
Measured: 1 year after inclusion
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
Measured: up to 90 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start15 Sep 2020
- Primary completionSep 2040 (estimated)
- Study completionMar 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadjib Hammoudi, MD, PhD, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992923
- Sponsor's protocol ID
- APHP200685
- Acronym
- EIPSL
- Status last verified
- Nov 2025
- First submitted
- 5 Nov 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Patients With Infective Endocarditis Admitted at Cardiology Institute of Pitié-Salpêtrière Hospital
- ClinicalTrials.gov ID
- NCT04992923
- Acronym / sponsor ID
- EIPSL / APHP200685
- Conditions
- Infective Endocarditis
- Keywords
- Infective endocarditis, prospective,, prognosis, biomarker, embolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- Sep 2040 (estimated)
- Study completion
- Mar 2041 (estimated)
- First posted
- 5 Aug 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients with IE admitted at Cardiology institute of the Pitié-Salpêtrière hospital
Key inclusion criteria (1 listed)
- Patients with confirmed IE according to European Society of Cardiology criteria
Key exclusion criteria (1 listed)
- Opposition of the patient to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause in hospital mortality
Time frame: up to 90 days
All-cause mortality during the length of hospital stay
12 secondary outcomes
All-cause mortality
Time frame: an average of 10 years
symptomatic or asymptomatic systemic embolism
Time frame: up to 90 days after inclusion
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
Time frame: inclusion
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
Time frame: up to 90 days after inclusion
heart failure, intracranial hemorrhage, or false vascular aneurysm during hospitalization
Time frame: up to 90 days after inclusion
Stroke
Time frame: 90 days after inclusion
composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence
Time frame: 1 year after inclusion
composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence
Time frame: through study completion, an average of 10 years
composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3
Time frame: 1 year after inclusion
composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3
Time frame: through study completion, an average of 10 years
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
Time frame: 1 year after inclusion
Occurrence of contrast-associated acute kidney injury during the length of hospital stay
Time frame: up to 90 days after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Nadjib Hammoudi, MD, PhD principal investigator
Pitié-Salpêtrière Hospital
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 Infective Endocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Nov 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadjib Hammoudi, MD, PhD (+33 142165535, nadjib.hammoudi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause in hospital mortality (time frame: up to 90 days). 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 21 Nov 2025.