Endocarditis Clinical Awareness, Research, and Evaluation in Sweden

NCT07671118 | Active Not Recruiting

• 1 other identifier: 2024-03639-01
• Study Type: observational
• Target: 22,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endocarditis Infective; Endocarditis Acute and Subacute; Endocarditis, Bacterial; Endocarditis Acute

Keywords

endocarditis; epidemiology; registers; SWEDEHEART; population-based; cohort study

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  From index diagnosis until end of available follow-up (up to 28 years)

Secondary Outcomes (6)

• Heart failure

  From index diagnosis until end of available follow-up (up to 28 years)

• Stroke

  From index diagnosis until end of available follow-up (up to 28 years)

• Major bleeding

  From index diagnosis until end of available follow-up (up to 28 years)

• Re-infection

  From index diagnosis until end of available follow-up (up to 28 years)

• Repeat valve surgery

  From index diagnosis until end of available follow-up (up to 28 years)

Study Arms (2)

Patients with infective endocarditis

Matched controls from the general population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Endocarditis; Endocarditis, Bacterial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Cardiovascular Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)