An observational study in Endocarditis Infective, Endocarditis Acute and Subacute and Endocarditis, Bacterial, sponsored by Karolinska Institutet. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Karolinska Institutet · Observational
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:
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.
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:
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.
22 studies on the registry are indexed under Endocarditis, Bacterial; 9 are open to participants now.
This study's planned enrollment of 22,000 is above the median of 588 across 10 observational studies indexed under Endocarditis, Bacterial.
Browse Endocarditis, Bacterial studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Compared within Endocarditis, Bacterial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Endocarditis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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.
Exclusion Criteria:
All-cause mortality
Time frame: From index diagnosis until end of available follow-up (up to 28 years)
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)
Plan to share: No — The data underlying this database cannot be shared publicly due to data protection regulations.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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