The SWISSHEART Failure Network (SHFN)

Acute Myocardial Infarction Clinical Trial

— Swissheart  

Official title:

SWISSHEART: Prediction and Progression of Heart Failure in Switzerland

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05603247
• Other study ID #: SHFN Swissheart
• Status: Active, not recruiting
• Start date: November 1, 2021
• Est. completion date: March 3, 2023

Study information

• Verified date: December 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Baseline data will be collected in the hospital during treatment will be complemented by a short outcome evaluation.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8000
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female or male patients, age > 18 years

2. Hospitalized with a primary diagnosis of AMI

a) 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

• 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

3. Hospitalization with a primary diagnosis of AHF based on the following criteria:

1. Symptoms: progressive dyspnoea, orthopnoea, paroxysmal nocturnal dyspnoea, AND/OR progressive peripheral oedema, weight gain.

AND at least TWO of the following:

2. Signs: basal pulmonary rales AND/OR peripheral oedema, jugular vein dilatation OR

3. 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

4. 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:

1. Female or male patients, age > 18 years

2. ECG and TTE recording performed within 5 days of each other

3. TTE is labelled as "normal".

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Heart Failure
• Heart Failure Acute
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital, Bern	Bern
Switzerland	University Hospital, Geneva	Geneva
Switzerland	University Hospital, Zurich	Zurich

Sponsors (5)

Lead Sponsor	Collaborator
University of Zurich	ETH Zurich, University Hospital, Basel, Switzerland, University Hospital, Geneva, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 3.5 years after last patient inclusion