Endocarditis Clinical Awareness, Research, and Evaluation in Sweden (ENDO-CARE)

June 26, 2026 updated by: Natalie Glaser, Karolinska Institutet

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:

  • 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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

22000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with infective endocarditis
Matched controls from the general population

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: From index diagnosis until end of available follow-up (up to 28 years)
From index diagnosis until end of available follow-up (up to 28 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart failure
Time Frame: From index diagnosis until end of available follow-up (up to 28 years)
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)
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)
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)
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)
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)
From index diagnosis until end of available follow-up (up to 28 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-03639-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data underlying this database cannot be shared publicly due to data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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