Endocarditis InfectiveENDO-CARENCT07671118
Endocarditis Clinical Awareness, Research, and Evaluation in Sweden
An observational study of Endocarditis Infective and Endocarditis Acute and Subacute, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of this observational study is to improve the understanding of infective endocarditis by investigating clinical characteristics, treatment strategies, and short- and long-term outcomes in patients diagnosed with infective endocarditis in Sweden. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endocarditis Infective, Endocarditis Acute and Subacute, Endocarditis, Bacterial
- How many people
- 22,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2025to 31 Dec 2028
- How long will I take part?
- 20 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is derived from the Swedish National Patient Register and includes all patients diagnosed with infective endocarditis who received care within the Swedish healthcare system. Using the unique personal identity number assigned to all Swedish residents, several nationwide Swedish health data registers has been cross-linked to obtain further information about baseline characteristics including socioeconomic information, cardiac surgery, endocarditis specific information such as microbiology, cardiac imaging and prescribed antibiotics, survival status and hospital admissions during follow-up. For each patient with infective endocarditis, four matched individuals from the general Swedish population are identified through the Swedish Population Register to serve as population comparators.
Who may be able to join
- Patients aged >18 years diagnosed with infective endocarditis in Sweden from January 1, 1997, and onwards, identified through nationwide Swedish health data registers.
- Individuals from the general population matched to patients with infective endocarditis (four comparators per patient) on age and sex.
Who cannot join
- Individuals with missing or invalid personal identity numbers precluding linkage between national registers.
- Individuals with incomplete or inconsistent registry information preventing determination of study eligibility or follow-up, where applicable to specific analyses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ENDO-CARE: Endocarditis Clinical Awareness, Research, and Evaluation in Sweden
The goal of this observational study is to improve the understanding of infective endocarditis by investigating clinical characteristics, treatment strategies, and short- and long-term outcomes in patients diagnosed with infective endocarditis in Sweden. The study includes all adults >18 years of age diagnosed with infective endocarditis in Sweden since 1997 through linkage of nationwide Swedish health data registers within the Endocarditis Clinical Awareness, Research and Evaluation in Sweden (ENDO-CARE) project. For each patient, four individuals from the general population matched on age and sex are included as population comparators.
The main questions it aims to answer are:
Read more
- Which patients with infective endocarditis benefit from valve surgery, and what is the optimal timing of surgery?
- Which patient-, disease-, microbiological-, and socioeconomic factors are associated with short- and long-term outcomes, including mortality, recurrent infective endocarditis, heart failure, stroke, and other major complications?
- How do long-term outcomes and life expectancy differ between patients with infective endocarditis and matched individuals from the general population?
- How have the incidence, management, microbiology, and outcomes of infective endocarditis changed over time?
Researchers will compare surgically and non-surgically treated patients, different clinical subgroups, and patients with infective endocarditis with matched population comparators to identify factors associated with treatment decisions, prognosis, and long-term outcomes.
Participants will not undergo any study-specific interventions or examinations. The study is based on linkage of existing nationwide Swedish health care and population registers, including data on hospital admissions, cardiac surgery, microbiology, prescribed medications, dental care, socioeconomic factors, and causes of death.
Read the detailed description
Infective endocarditis (IE) is a rare but life-threatening disease associated with high morbidity and mortality despite advances in diagnostic methods, antimicrobial therapy, and cardiac surgery. Although current international guidelines provide recommendations concerning management of patients with infective endocarditis, many important clinical questions remain unanswered because randomized clinical trials are difficult to perform in this patient population. Consequently, most evidence is derived from observational studies, which are often limited by small sample sizes, selected patient populations, and relatively short follow-up.
The Endocarditis Clinical Awareness, Research and Evaluation in Sweden (ENDO-CARE) project is a nationwide research platform established to improve the understanding of infective endocarditis through comprehensive linkage of Swedish national health data registers. The ENDO-CARE database includes all patients diagnosed with infective endocarditis in Sweden since 1997. In addition, four matched individuals from the general population are included for each patient to enable comparisons of long-term outcomes and life expectancy with the background population.
The database integrates information from multiple nationwide registers, including hospital admissions, diagnoses, cardiac surgery, microbiology, echocardiographic findings, prescribed medications, socioeconomic factors, dental care, causes of death, and other population-based health registers. Individual-level linkage is performed using the unique Swedish personal identity number before data are pseudonymized for research purposes.
The overall objective of ENDO-CARE is to broaden the knowledge about endocarditis and to improve the evidence base for the management of infective endocarditis. Planned studies will investigate patient characteristics, microbiology, cardiac imaging findings, treatment strategies, and both short- and long-term outcomes.
Particular emphasis will be placed on:
- Evaluating indications for and timing of valve surgery
- Identifying patient groups that benefit most from surgical intervention
- Assessing temporal trends in incidence and management
- Investigating prognostic factors and risk stratification
- Evaluating long-term survival and life expectancy
- Studying disparities in care related to sex, age, and socioeconomic status.
The ENDO-CARE platform is designed to support multiple observational studies using modern epidemiological methods. The comprehensive nationwide design minimizes selection bias, enables complete follow-up through national registers, and allows the study of rare patient subgroups and clinically important outcomes that cannot readily be evaluated in randomized clinical trials.
The knowledge generated through ENDO-CARE is expected to improve risk stratification, support clinical decision-making regarding medical and surgical treatment, inform future national and international clinical guidelines, and ultimately contribute to more individualized and equitable care for patients with infective endocarditis.
- Conditions
- Endocarditis Infective, Endocarditis Acute and Subacute, Endocarditis, Bacterial, Endocarditis Acute
- Keywords
- endocarditis, epidemiology, registers, SWEDEHEART, population-based, cohort study
- Medical subject headings
- Endocarditis, Endocarditis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with infective endocarditis | Not described | |
| Matched controls from the general population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: From index diagnosis until end of available follow-up (up to 28 years)
Secondary outcomes (6)
Heart failure
Measured: From index diagnosis until end of available follow-up (up to 28 years)
Stroke
Measured: From index diagnosis until end of available follow-up (up to 28 years)
Major bleeding
Measured: From index diagnosis until end of available follow-up (up to 28 years)
Re-infection
Measured: From index diagnosis until end of available follow-up (up to 28 years)
Repeat valve surgery
Measured: From index diagnosis until end of available follow-up (up to 28 years)
Cardiovascular death
Measured: From index diagnosis until end of available follow-up (up to 28 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocarditis InfectiveStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 22,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Glaser, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671118
- Sponsor's protocol ID
- 2024-03639-01
- Acronym
- ENDO-CARE
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data underlying this database cannot be shared publicly due to data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDO-CARE: Endocarditis Clinical Awareness, Research, and Evaluation in Sweden
- ClinicalTrials.gov ID
- NCT07671118
- Acronym / sponsor ID
- ENDO-CARE / 2024-03639-01
- Conditions
- Endocarditis Infective, Endocarditis Acute and Subacute, Endocarditis, Bacterial, Endocarditis Acute
- Keywords
- endocarditis, epidemiology, registers, SWEDEHEART, population-based, cohort study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 22,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Jun 2026 (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.
The goal of this observational study is to improve the understanding of infective endocarditis by investigating clinical characteristics, treatment strategies, and short- and long-term outcomes in patients diagnosed with infective endocarditis in Sweden. The study includes all adults >18 years of age diagnosed with infective endocarditis in Sweden since 1997 through linkage of nationwide Swedish health data registers within the Endocarditis Clinical Awareness, Research and Evaluation in Sweden (ENDO-CARE) project. For each patient, four individuals from the general population matched on age and sex are included as population comparators.
The main questions it aims to answer are:
- Which patients with infective endocarditis benefit from valve surgery, and what is the optimal timing of surgery?
- Which patient-, disease-, microbiological-, and socioeconomic factors are associated with short- and long-term outcomes, including mortality, recurrent infective endocarditis, heart failure, stroke, and other major complications?
- How do long-term outcomes and life expectancy differ between patients with infective endocarditis and matched individuals from the general population?
- How have the incidence, management, microbiology, and outcomes of infective endocarditis changed over time?
Researchers will compare surgically and non-surgically treated patients, different clinical subgroups, and patients with infective endocarditis with matched population comparators to identify factors associated with treatment decisions, prognosis, and long-term outcomes.
Participants will not undergo any study-specific interventions or examinations. The study is based on linkage of existing nationwide Swedish health care and population registers, including data on hospital admissions, cardiac surgery, microbiology, prescribed medications, dental care, socioeconomic factors, and causes of death.
Detailed description
Infective endocarditis (IE) is a rare but life-threatening disease associated with high morbidity and mortality despite advances in diagnostic methods, antimicrobial therapy, and cardiac surgery. Although current international guidelines provide recommendations concerning management of patients with infective endocarditis, many important clinical questions remain unanswered because randomized clinical trials are difficult to perform in this patient population. Consequently, most evidence is derived from observational studies, which are often limited by small sample sizes, selected patient populations, and relatively short follow-up.
The Endocarditis Clinical Awareness, Research and Evaluation in Sweden (ENDO-CARE) project is a nationwide research platform established to improve the understanding of infective endocarditis through comprehensive linkage of Swedish national health data registers. The ENDO-CARE database includes all patients diagnosed with infective endocarditis in Sweden since 1997. In addition, four matched individuals from the general population are included for each patient to enable comparisons of long-term outcomes and life expectancy with the background population.
The database integrates information from multiple nationwide registers, including hospital admissions, diagnoses, cardiac surgery, microbiology, echocardiographic findings, prescribed medications, socioeconomic factors, dental care, causes of death, and other population-based health registers. Individual-level linkage is performed using the unique Swedish personal identity number before data are pseudonymized for research purposes.
The overall objective of ENDO-CARE is to broaden the knowledge about endocarditis and to improve the evidence base for the management of infective endocarditis. Planned studies will investigate patient characteristics, microbiology, cardiac imaging findings, treatment strategies, and both short- and long-term outcomes.
Particular emphasis will be placed on:
- Evaluating indications for and timing of valve surgery
- Identifying patient groups that benefit most from surgical intervention
- Assessing temporal trends in incidence and management
- Investigating prognostic factors and risk stratification
- Evaluating long-term survival and life expectancy
- Studying disparities in care related to sex, age, and socioeconomic status.
The ENDO-CARE platform is designed to support multiple observational studies using modern epidemiological methods. The comprehensive nationwide design minimizes selection bias, enables complete follow-up through national registers, and allows the study of rare patient subgroups and clinically important outcomes that cannot readily be evaluated in randomized clinical trials.
The knowledge generated through ENDO-CARE is expected to improve risk stratification, support clinical decision-making regarding medical and surgical treatment, inform future national and international clinical guidelines, and ultimately contribute to more individualized and equitable care for patients with infective endocarditis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with infective endocarditis | – | – |
| Matched controls from the general population | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is derived from the Swedish National Patient Register and includes all patients diagnosed with infective endocarditis who received care within the Swedish healthcare system. Using the unique personal identity number assigned to all Swedish residents, several nationwide Swedish health data registers has been cross-linked to obtain further information about baseline characteristics including socioeconomic information, cardiac surgery, endocarditis specific information such as microbiology, cardiac imaging and prescribed antibiotics, survival status and hospital admissions during follow-up. For each patient with infective endocarditis, four matched individuals from the general Swedish population are identified through the Swedish Population Register to serve as population comparators.
Key inclusion criteria (2 listed)
- Patients aged >18 years diagnosed with infective endocarditis in Sweden from January 1, 1997, and onwards, identified through nationwide Swedish health data registers.
- Individuals from the general population matched to patients with infective endocarditis (four comparators per patient) on age and sex.
Key exclusion criteria (2 listed)
- Individuals with missing or invalid personal identity numbers precluding linkage between national registers.
- Individuals with incomplete or inconsistent registry information preventing determination of study eligibility or follow-up, where applicable to specific analyses.
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 mortality
Time frame: From index diagnosis until end of available follow-up (up to 28 years)
6 secondary outcomes
Heart failure
Time frame: From index diagnosis until end of available follow-up (up to 28 years)
Stroke
Time frame: From index diagnosis until end of available follow-up (up to 28 years)
Major bleeding
Time frame: From index diagnosis until end of available follow-up (up to 28 years)
Re-infection
Time frame: From index diagnosis until end of available follow-up (up to 28 years)
Repeat valve surgery
Time frame: From index diagnosis until end of available follow-up (up to 28 years)
Cardiovascular death
Time frame: From index diagnosis until end of available follow-up (up to 28 years)
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 30 Jun 2026.
- Individual participant dataSharing planned: No. The data underlying this database cannot be shared publicly due to data protection regulations.
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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 Endocarditis Infective and Endocarditis Acute and Subacute, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. 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 Sweden. 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?
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?
All-cause mortality (time frame: From index diagnosis until end of available follow-up (up to 28 years)). 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 30 Jun 2026.