About this trial

This study seeks to investigate the clinical value of novel echocardiographic indices, including myocardial work parameters, during the acute phase of heart failure hospitalization. The trajectory of novel echocardiographic indices from the start to the end of hospitalization will be captured, as a means to unravel and subsequently better understand the diverse pathophysiology of different phenotypes of the heart failure continuum. Correlation between novel echocardiographic indices with clinical data, biochemical data, different heart failure phenotypes, and therapeutic maneuvers will be attempted. Prognostic implications of those indices will be explored.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients acutely admitted at the Department of Cardiology of AHEPA University General Hospital, Thessaloniki, Greece with symptoms and/or signs of heart failure (HF), as those are defined by the European Society of Cardiology.

Patients with abnormal plasma concentration of N-terminal pro-B-type natriuretic peptide, measured within 24 hours from admission

Objective echocardiographic evidence of cardiac structural and/or functional abnormalities consistent with the presence of left ventricular (LV) systolic dysfunction/diastolic dysfunction/raised LV filling pressures upon admission assessment

Disqualifiers

Symptoms and/or signs of HF secondary to congenital heart disease, infective endocarditis, pericardial disease, and history of recent cardiac surgery (<1 month)

Patients receiving maintenance hemodialysis

Patients with active malignancy and/or life expectancy < 1 year

Poor echocardiographic acoustic windows precluding reliable assessment and/or analysis

Trial population

All adult patients acutely admitted at the Department of Cardiology of AHEPA University General Hospital, Thessaloniki, Greece with symptoms and/or signs of heart failure, as those are specified by most updated guidelines, will be considered for enrollment in the present study. All participants will have elevated plasma concentration of N-terminal pro-B-type natriuretic peptide, measured within 24 hours from admission as well as objective echocardiographic evidence of cardiac structural and/or functional abnormalities consistent with the presence of left ventricular (LV) systolic dysfunction/diastolic dysfunction/raised LV filling pressures upon admission assessment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkers
Diagnostic test
Complete and comprehensive medical interview will be conducted in each eligible patient. In addition, patient's laboratory data will be recorded on admission and pre-discharge. Each patient will undergo a full echocardiographic examination with a specific protocol upon admission and pre-discharge. This will include among others 2-dimensional speckle-tracking analysis of all cardiac chambers, and non-invasive calculation of myocardial work indices of the left and right ventricle.

Treatment groups

300 Participants

are divided into 3 treatment groups

Group A: Heart failure with reduced ejection fraction1 intervention

Group B: Heart failure with mid-range ejection fraction1 intervention

Group C: Heart failure with preserved ejection fraction1 intervention

Trial outcomes

Primary outcomes

1

Relationship between different heart failure sub-groups and echocardiographic indices

Conventional and novel echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers.

Time frame

12 months

Secondary outcomes

1

Relationship between therapeutic management of acute heart failure, laboratory profile, and net changes of echocardiographic indices

Pharmacological and non-pharmacological therapeutic management of acute heart failure, duration of hospitalization, and laboratory profile with net variations of conventional and novel echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, and 2-dimensional speckle-tracking analysis of all cardiac chambers.

Time frame

12 months

2

Prognostic factors in acute and chronic heart failure

Clinical, laboratory, and echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers. Different units of measure in this outcome do not represent different outcome measures. All clinical, laboratory and echocardiographic measurements will be evaluated separately in their own unit of measurement to assess potential prognostic biomarkers in patients with heart failure. This does not render the measurement of each parameter a different clinical outcome.

Time frame

12 months

3

Relationship between clinical, laboratory, and echocardiographic biomarkers with short- and long-term prognosis of patients

Clinical, laboratory, and echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers.

Time frame

12 months

Novel Echocardiographic Biomarkers Assessing the Myocardial Work in Heart Failure

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts