Heart FailureNCT07634822
Heart Failure and Postoperative Outcome in Surgery - a National Registry Study
An observational study of Heart Failure and Diastolic Heart Failure, run by Umeå University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic Heart Failure, Systolic Heart Failure
- How many people
- 2,200,000 participants
- Where
- 2 sitesSweden
- Study dates
- Aug 2026to Dec 2030
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥18 years of age who underwent surgery in Sweden between 1 Jan 2021-31 Dec 2024.
Who may be able to join
- ≥18 years of age who underwent surgery in Sweden between 1 Jan 2021-31 Dec 2024 and SPOR registered operation.
Who cannot join
- ASA 6 (deceased patient, organ donation).
- Cardiac surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites
Region Norrbotten, department of Anesthesia and Intensive Care, Sunderby Hospital
Luleå
Tomi Myrberg, Associate professor
Institution for Diagnostic and Intervention, dep of Anestesiology and Intensive care
Umeå
Tomi Myrberg, Associate professor, +46920282236, tomi.myrberg@umu.se
Tomi Myrberg, Associate professor
About this study
Official title: Incidence of Heart Failure and Its Association With Postoperative Mortality in Surgery - a National Registry Study
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.
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic
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 |
|---|---|---|
| Surgery with SPOR registration | Surgery registered in SPOR registry between 2021--2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative mortality
How does a heart failure diagnosis affect postoperative mortality at 30 days, 90 days, 180 days, and 365 days?
Measured: 365 days
Postoperative morbidity
How does a heart failure diagnosis associated with postoperative morbidity at 30 days?
Measured: 30 days postoperative
Secondary outcomes (1)
Prevalence of heart failure
What is prevalence of heart failure in surgery in Sweden?
Measured: 5 years preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Other
- Enrolment
- 2,200,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Norrbotten
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634822
- Sponsor's protocol ID
- Dnr 2026-01286-01
- Other IDs
- 36223/2026, 36223/2026, DAT-1428
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not actual in this study concept
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Heart Failure and Its Association With Postoperative Mortality in Surgery - a National Registry Study
- ClinicalTrials.gov ID
- NCT07634822
- Acronym / sponsor ID
- Dnr 2026-01286-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,200,000 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Norrbotten
- Study start
- Aug 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 9 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery with SPOR registration | – | –Surgery registered in SPOR registry between 2021--2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years of age who underwent surgery in Sweden between 1 Jan 2021-31 Dec 2024.
Key inclusion criteria (1 listed)
- ≥18 years of age who underwent surgery in Sweden between 1 Jan 2021-31 Dec 2024 and SPOR registered operation.
Key exclusion criteria (2 listed)
- ASA 6 (deceased patient, organ donation).
- Cardiac surgery
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
Postoperative mortality
Time frame: 365 days
How does a heart failure diagnosis affect postoperative mortality at 30 days, 90 days, 180 days, and 365 days?
Postoperative morbidity
Time frame: 30 days postoperative
How does a heart failure diagnosis associated with postoperative morbidity at 30 days?
1 secondary outcome
Prevalence of heart failure
Time frame: 5 years preoperative
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 9 Jun 2026.
- Background1. 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
- Individual participant dataSharing planned: No. Not actual in this study concept
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Diastolic Heart Failure, run by Umeå University at 2 sites 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 1 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: opening soon, as of the sponsor's last update on 9 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 2 sites 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?
Contact Tomi Myrberg, Associate professor (+46920282236, tomi.myrberg@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative mortality (time frame: 365 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07634822, which also lists 1 linked publication.
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 9 Jun 2026.