NCT07634822

Brief Summary

The study is an exploratory study that aims to explore the incidence of heart failure in a national surgical cohort, and to compare postoperative mortality and morbidity in patients with and without heart failure. Furthermore, we want to investigate differences in the incidence of heart failure and its impact on postoperative morbidity and mortality in day surgery compared to inpatient surgery.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200,000

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Aug 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

Diastolic Heart FailureHeart FailureSystolic Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Postoperative mortality

    How does a heart failure diagnosis affect postoperative mortality at 30 days, 90 days, 180 days, and 365 days?

    365 days

  • Postoperative morbidity

    How does a heart failure diagnosis associated with postoperative morbidity at 30 days?

    30 days postoperative

Secondary Outcomes (1)

  • Prevalence of heart failure

    5 years preoperative

Other Outcomes (2)

  • Differences between ambulatory and inpatient surgery

    365 postoperative

  • Difference in prevalence of heart failure

    5 years preoperative

Study Arms (1)

Surgery with SPOR registration

Surgery registered in SPOR registry between 2021--2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients ≥18 years of age who underwent surgery in Sweden between 1 Jan 2021-31 Dec 2024.

You may qualify if:

  • ≥18 years of age who underwent surgery in Sweden between 1 Jan 2021-31 Dec 2024 and SPOR registered operation.

You may not qualify if:

  • ASA 6 (deceased patient, organ donation).
  • Cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Region Norrbotten, department of Anesthesia and Intensive Care, Sunderby Hospital

Luleå, Sweden

Location

Institution for Diagnostic and Intervention, dep of Anestesiology and Intensive care

Umeå, Sweden

Location

Related Publications (1)

  • 1. Griffiths R, Beech F, Brown A, Dhesi J, Foo I, Goodall J, et al. Peri-operative care of the elderly 2014: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2014;69 Suppl 1:81-98. 2. Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, et al. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015;385 Suppl 2:S11. 3. Eriksson J, Sandberg C, Kilhamn N, Bell M, Oldner A, Larsson E. Surgery in patients aged ≥ 80 years: mortality and recovery in a nationwide cohort study. Anaesthesia. 2025;80(7):812-22. 4. McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. European journal of heart failure. 2022;24(1):4-131. 5. Lindberg F, Benson L, Dahlström U, Lund LH, Savarese G. Trends in Heart Failure Mortality in Sweden Between 1997 and 2022. European journal of heart failure. 2024;27(2):366-76. 6. Shah KS, Xu H, Matsouaka RA, Bhatt DL, Heidenreich PA, Hernandez AF, et al. Heart Failure With Preserved, Borderline, and Reduced Ejection Fraction: 5-Year Outcomes. J Am Coll Cardiol. 2017;70(20):2476-86. 7. Levy D, Kenchaiah S, Larson MG, Benjamin EJ, Kupka MJ, Ho KK, et al. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002;347(18):1397-402. 8. Hernandez AF, Whellan DJ, Stroud S, Sun JL, O'Connor CM, Jollis JG. Outcomes in heart failure patients after major noncardiac surgery. J Am Coll Cardiol. 2004;44(7):1446-53. 9. van Diepen S, Bakal JA, McAlister FA, Ezekowitz JA. Mortality and Readmission of Patients With Heart Failure, Atrial Fibrillation, or Coronary Artery Disease Undergoing Noncardiac Surgery. Circulation. 2011;124

    BACKGROUND

MeSH Terms

Conditions

Heart FailureHeart Failure, DiastolicHeart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Tomi Myrberg, Associate professor

CONTACT

+46920282236tomi.myrberg@umu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 9, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2030

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Not actual in this study concept

Locations

SE(2)