Heart Failure AcuteSwissheartNCT05603247
The SWISSHEART Failure Network (SHFN)
An observational study of Heart Failure Acute and Acute Myocardial Infarction, run by University of Zurich at 4 sites in Switzerland.
Trial summary
A retrospective cohort study will be conducted on patients who were hospitalized at the University Hospital Basel (USB), University Hospital Bern (Inselspital), University Hospital Geneva (HUG) and the University Hospital Zurich (USZ) with the diagnosis of AMI and/or AHF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Acute, Acute Myocardial Infarction
- How many people
- 8,000 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 1 Nov 2021to 3 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients identified with the respective ICD-10 codes for AMI and/or the phenotype of "AHF" will undergo detailed medical review to verify patients' diagnosis of AMI and/or AHF according to current ESC guidelines that are reflected in the subsequent inclusion criteria. As there is no specific ICD-10 coding for AHF, inclusion is based on several criteria including signs and symptoms, lab values, typical drugs and echocardiographic criteria within a specific time window.
Who may be able to join
- Female or male patients, age > 18 years
- Hospitalized with a primary diagnosis of AMI
- ST-segment elevation Myocardial Infarction (STEMI) and Non-STEMI (NSTEMI) have to fulfil the 4th universal definition of myocardial infarction.
- Acute myocardial injury with dynamic cardiac troponin (cTn) changes (at least one value above 99th per-centile URL) AND
- At least ONE of the following:
- Symptoms of myocardial ischemia
Show all 19Show fewer
- New ischemic ECG changes or new pathological Q waves
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality consistent with ischemic etiology
- Intracoronary thrombus on angiography (or autopsy) AND/OR
- Hospitalization with a primary diagnosis of AHF based on the following criteria:
- Symptoms: progressive dyspnoea, orthopnoea, paroxysmal nocturnal dyspnoea, AND/OR progressive peripheral oedema, weight gain.
- AND at least TWO of the following:
- Signs: basal pulmonary rales AND/OR peripheral oedema, jugular vein dilatation OR
- N-terminal prohormone of brain natriuretic peptide (NT-proBNP) within 24 hours >450 pg/ml if age <50 years, >900 pg/ml if age 50-75 years, >1800 pg/ml if age >75 years) OR BNP >400 pg/ml. Cut-offs need to be reduced by 50% in case of severe obesity (BMI >35) OR
- Treatment of AHF within 24 h using the following drugs i) increased diuretics. iv furosemide or increased po furosemide or torasemide ii) inotropes (dobutamine, dopamine, levosimendan, milrinone) iii) i.v. or s.l. vasodilators (nitroglycerine, isosorbide dinitrate) iv) vasopressors (norepinephrine) OR e) Echocardiographic features (within 72 hours) -- automated TTE downloads left ventricular ejection fraction (LVEF) <40% or estimated pulmonary artery systolic pressure (PASP) >40 mmHg or increased estimated right atrium pressure (RA) pressure above 10 mmHg (VCI size / resp. motion)
- For the control cohort, the inclusion criteria are:
- Female or male patients, age > 18 years
- ECG and TTE recording performed within 5 days of each other
- TTE is labelled as "normal".
Who cannot join
- If a subject fulfills the following exclusion criteria, he/she may not be included: Existence of a documented statement of the patient against the use of his/her clinical data for research purposes.
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
University Hospital Basel
Basel
University Hospital, Bern
Bern
University Hospital, Geneva
Geneva, 1211
University Hospital, Zurich
Zurich
About this study
Official title: SWISSHEART: Prediction and Progression of Heart Failure in Switzerland
A retrospective cohort study will be conducted on patients who were hospitalized at the University Hospital Basel (USB), University Hospital Bern (Inselspital), University Hospital Geneva (HUG) and the University Hospital Zurich (USZ) with the diagnosis of AMI and/or AHF. Baseline data will be collected in the hospital during treatment will be complemented by a short outcome evaluation.
Read the detailed description
The SWISSHEART Failure (SHF) Registry collects retrospectively Swiss-wide standardized clinical, laboratory, raw data electrocardiograms (ECG) and transthoracic echocardiographies (TTE) of a large number of patients hospitalized for Acute Heart Failure (AHF) or for Acute Myocardial Infarction (AMI), this latter group being at risk of developing heart failure as a consequence of the AMI episode.
Using state-of-the-art statistics and machine learning (ML)-based analyses, This project aims to improve prediction and prevention of heart failure (HF) in AMI patients and understand progression or regression of HF in AHF patients.
- Conditions
- Heart Failure Acute, Acute Myocardial Infarction
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 |
|---|---|---|
| Acute myocardial infarction (AMI) and acute heart failure (AHF) | All patients identified with the respective International Statistical Classification of Diseases and Related Health Problems (ICD) 10th revision codes for AMI and/or the phenotype of "AHF" will undergo detailed medical review to verify patients' diagnosis of AMI and/or AHF according to current European Society of Cardiology (ESC) guidelines that are reflected in the subsequent inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with major adverse cardiac events (MACE) until March 2023
MACE is composed of
- All-cause death
- Cardiovascular Death
- Acute myocardial infarction
- Hospitalization for heart failure
Measured: up to 3.5 years after last patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Nov 2021
- Primary completion3 Mar 2023 (estimated)
- Study completion3 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure AcuteStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, University Hospital, Basel, Switzerland, University of Bern, ETH Zurich
- Responsible party
- Sponsor
- Investigators
- Christian M Matter, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603247
- Sponsor's protocol ID
- SHFN Swissheart
- Acronym
- Swissheart
- Status last verified
- Dec 2022
- First submitted
- 20 Oct 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWISSHEART: Prediction and Progression of Heart Failure in Switzerland
- ClinicalTrials.gov ID
- NCT05603247
- Acronym / sponsor ID
- Swissheart / SHFN Swissheart
- Conditions
- Heart Failure Acute, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, University Hospital, Basel, Switzerland, University of Bern, ETH Zurich
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 3 Mar 2023 (estimated)
- Study completion
- 3 Mar 2023 (estimated)
- First posted
- 2 Nov 2022 (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.
A retrospective cohort study will be conducted on patients who were hospitalized at the University Hospital Basel (USB), University Hospital Bern (Inselspital), University Hospital Geneva (HUG) and the University Hospital Zurich (USZ) with the diagnosis of AMI and/or AHF. Baseline data will be collected in the hospital during treatment will be complemented by a short outcome evaluation.
Detailed description
The SWISSHEART Failure (SHF) Registry collects retrospectively Swiss-wide standardized clinical, laboratory, raw data electrocardiograms (ECG) and transthoracic echocardiographies (TTE) of a large number of patients hospitalized for Acute Heart Failure (AHF) or for Acute Myocardial Infarction (AMI), this latter group being at risk of developing heart failure as a consequence of the AMI episode.
Using state-of-the-art statistics and machine learning (ML)-based analyses, This project aims to improve prediction and prevention of heart failure (HF) in AMI patients and understand progression or regression of HF in AHF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute myocardial infarction (AMI) and acute heart failure (AHF) | – | –All patients identified with the respective International Statistical Classification of Diseases and Related Health Problems (ICD) 10th revision codes for AMI and/or the phenotype of "AHF" will undergo detailed medical review to verify patients' diagnosis of AMI and/or AHF according to current European Society of Cardiology (ESC) guidelines that are reflected in the subsequent inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients identified with the respective ICD-10 codes for AMI and/or the phenotype of "AHF" will undergo detailed medical review to verify patients' diagnosis of AMI and/or AHF according to current ESC guidelines that are reflected in the subsequent inclusion criteria. As there is no specific ICD-10 coding for AHF, inclusion is based on several criteria including signs and symptoms, lab values, typical drugs and echocardiographic criteria within a specific time window.
Key inclusion criteria (19 listed)
- Female or male patients, age > 18 years
- Hospitalized with a primary diagnosis of AMI
- Hospitalization with a primary diagnosis of AHF based on the following criteria:
- Female or male patients, age > 18 years
- ECG and TTE recording performed within 5 days of each other
Key exclusion criteria (1 listed)
- If a subject fulfills the following exclusion criteria, he/she may not be included: Existence of a documented statement of the patient against the use of his/her clinical data for research purposes.
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
Number of participants with major adverse cardiac events (MACE) until March 2023
Time frame: up to 3.5 years after last patient inclusion
MACE is composed of * All-cause death * Cardiovascular Death * Acute myocardial infarction * Hospitalization for heart failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
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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. This study is not recruiting at the moment.
Christian M Matter, MD principal investigator
University of Zurich
4 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 Acute and Acute Myocardial Infarction, run by University of Zurich at 4 sites in Switzerland.
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 19 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with major adverse cardiac events (MACE) until March 2023 (time frame: up to 3.5 years after last patient inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2022.