Cardiovascular DiseasesBeyond-MyoHFNCT05573997
Novel Echocardiographic Biomarkers Assessing the Myocardial Work in Heart Failure
An observational study of Cardiovascular Diseases and Heart Failure, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This study seeks to investigate the clinical value of novel echocardiographic indices, including myocardial work parameters, during the acute phase of heart failure hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Failure, Valvular Heart Disease
- What is being tested?
- Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkers
- How many people
- 300 participants
- Where
- 1 siteGreece
- Study dates
- 10 Apr 2022to 10 Jan 2025
- How long will I take part?
- 12 Months
- 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 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.
Who may be able to join
- 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
Who cannot join
- 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
- Heart transplantation
- Patients not providing informed written consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University Hospital, Thessaloniki, Greece
Thessaloniki, Central Macedonia, 54621
Stylianos Daios, MD, MSc, 6947529606 ext. +30, stylianoschrys.daios@gmail.com
Vasileios Anastasiou, MD, MSc, 6978223907 ext. +30, vasianas44@gmail.com
About this study
Official title: Clinical Value of Novel Echocardiographic Biomarkers Assessing the Myocardial Work in Heart Failure
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.
Read the detailed description
Despite ongoing advances in early diagnosis and therapy, heart failure (HF) represents a worldwide health burden with high in-hospital mortality during the acute phase of hospitalization and high readmission rates following the event of decompensation. Patients acutely hospitalized for HF represent a widely heterogenous population in terms of primary etiology, clinical manifestations, echocardiographic characteristics, appropriate therapeutic management, and prognosis.
As more advanced HF therapeutic strategies are emerging, the cardiology community attempts to identify new HF sub-phenotypes that will serve as successful recipients of such treatments. The role of echocardiography in this attempt is far from exhausted, as novel indices are entering the research arena potentially capable of identifying new phenotypes, enlightening the subtending pathophysiology, and providing incremental prognostic information.
All adult patients acutely admitted at the Department of Cardiology at AHEPA University General Hospital of Thessaloniki with symptoms and/or signs of HF meeting the inclusion criteria will be invited to participate in the present study. A complete and comprehensive medical interview will be conducted in each eligible patient. Demographic characteristics and baseline medical history, including primary etiology and clinical presentation of hospitalization will be recorded for all participants. Pharmacological and non-pharmacological standard of care therapeutic maneuvers during the acute phase of hospitalization, as well as medical therapy upon admission and discharge will be collected. A comprehensive transthoracic echocardiographic assessment (TTE) including 2-dimensional-speckle-tracking analysis of all cardiac chambers, and non-invasive calculation of myocardial work of the left and right ventricle will be performed during hospitalization. The first TTE will be performed within 24 hours from admission, and the second within 24 hours pre-discharge, to capture the trajectory and net variations of all echocardiographic indices of interest. Blood samples for biochemical analysis, including N-terminal pro-B-type natriuretic peptide plasma concentrations will be collected upon admission and prior to discharge.
Through this prospective registry, association of novel echocardiographic indices and their net changes during hospitalization with clinical and biochemical data, diverse HF phenotypes, therapeutic maneuvers, and response to treatment will be attempted, as a means to explore the pathophysiology of different HF phenotypes and ultimately provide individualized acute HF management guidance. The clinical value and prognostic implications of those echocardiographic indices will be investigated during follow-up.
- Being tested
- Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkers
- Keywords
- Heart Failure, Echocardiography, Myocardial Work, Functional Valvular Heart Disease
- Medical subject headings
- Cardiovascular Diseases, Heart Failure, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkersDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure with reduced ejection fraction | Left Ventricular Ejection Fraction of ≤40% Receives: Diagnostic Test: Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkers | |
| Heart failure with mid-range ejection fraction | Left Ventricular Ejection Fraction of 41-49% Receives: Diagnostic Test: Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkers | |
| Heart failure with preserved ejection fraction | Left Ventricular Ejection Fraction of ≥50% Receives: Diagnostic Test: Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start10 Apr 2022
- Primary completion10 Dec 2024 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vasileios Kamperidis, MD, MSc, PhD, Study director, School of Medicine, Aristotle University of ThessalonikiAntonios Ziakas, MD, PhD, Study chair, Information provided by (Responsible Party):
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573997
- Sponsor's protocol ID
- 19/2022
- Acronym
- Beyond-MyoHF
- Status last verified
- Jul 2024
- First submitted
- 2 Oct 2022
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anastasiou V, Stavropoulou E, Peteinidou E, Nikolaidou A, Daios S, Fardoulis E, Karamitsos T, Giannakoulas G, Naka KKappa, Delgado V, Ziakas A, Kamperidis V. Dynamic Changes in Right Ventricular-Pulmonary Arterial Coupling During Acute Heart Failure Hospitalization: Prognostic Implications. Am J Cardiol. 2026 Mar 1;262:6-15. doi: 10.1016/j.amjcard.2025.12.010. Epub 2025 Dec 28.
PubMed 41468984Anastasiou V, Papazoglou AS, Daios S, Peteinidou E, Nikolaidou A, Fardoulis E, Didagelos M, Karamitsos T, Giannakoulas G, Delgado V, Ziakas A, Kamperidis V. Prognostic Role of Right Atrial Reservoir Strain in Acute Heart Failure. Can J Cardiol. 2025 Oct;41(10):2085-2095. doi: 10.1016/j.cjca.2025.06.010. Epub 2025 Jun 23.
PubMed 40562231
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Novel Echocardiographic Biomarkers Assessing the Myocardial Work in Heart Failure
- ClinicalTrials.gov ID
- NCT05573997
- Acronym / sponsor ID
- Beyond-MyoHF / 19/2022
- Keywords
- Heart Failure, Echocardiography, Myocardial Work, Functional Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 10 Oct 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.
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.
Detailed description
Despite ongoing advances in early diagnosis and therapy, heart failure (HF) represents a worldwide health burden with high in-hospital mortality during the acute phase of hospitalization and high readmission rates following the event of decompensation. Patients acutely hospitalized for HF represent a widely heterogenous population in terms of primary etiology, clinical manifestations, echocardiographic characteristics, appropriate therapeutic management, and prognosis.
As more advanced HF therapeutic strategies are emerging, the cardiology community attempts to identify new HF sub-phenotypes that will serve as successful recipients of such treatments. The role of echocardiography in this attempt is far from exhausted, as novel indices are entering the research arena potentially capable of identifying new phenotypes, enlightening the subtending pathophysiology, and providing incremental prognostic information.
All adult patients acutely admitted at the Department of Cardiology at AHEPA University General Hospital of Thessaloniki with symptoms and/or signs of HF meeting the inclusion criteria will be invited to participate in the present study. A complete and comprehensive medical interview will be conducted in each eligible patient. Demographic characteristics and baseline medical history, including primary etiology and clinical presentation of hospitalization will be recorded for all participants. Pharmacological and non-pharmacological standard of care therapeutic maneuvers during the acute phase of hospitalization, as well as medical therapy upon admission and discharge will be collected. A comprehensive transthoracic echocardiographic assessment (TTE) including 2-dimensional-speckle-tracking analysis of all cardiac chambers, and non-invasive calculation of myocardial work of the left and right ventricle will be performed during hospitalization. The first TTE will be performed within 24 hours from admission, and the second within 24 hours pre-discharge, to capture the trajectory and net variations of all echocardiographic indices of interest. Blood samples for biochemical analysis, including N-terminal pro-B-type natriuretic peptide plasma concentrations will be collected upon admission and prior to discharge.
Through this prospective registry, association of novel echocardiographic indices and their net changes during hospitalization with clinical and biochemical data, diverse HF phenotypes, therapeutic maneuvers, and response to treatment will be attempted, as a means to explore the pathophysiology of different HF phenotypes and ultimately provide individualized acute HF management guidance. The clinical value and prognostic implications of those echocardiographic indices will be investigated during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heart failure with reduced ejection fraction | – | Diagnostic Test: Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkersLeft Ventricular Ejection Fraction of ≤40% |
| Heart failure with mid-range ejection fraction | – | Diagnostic Test: Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkersLeft Ventricular Ejection Fraction of 41-49% |
| Heart failure with preserved ejection fraction | – | Diagnostic Test: Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkersLeft Ventricular Ejection Fraction of ≥50% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Heart transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigation of clinical profile, laboratory and novel echocardiographic imaging biomarkersComplete 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. | Diagnostic test | Heart failure with mid-range ejection fraction, Heart failure with preserved ejection fraction, Heart failure with reduced ejection fraction |
Primary outcome
Relationship between different heart failure sub-groups and echocardiographic indices
Time frame: 12 months
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.
3 secondary outcomes
Relationship between therapeutic management of acute heart failure, laboratory profile, and net changes of echocardiographic indices
Time frame: 12 months
Prognostic factors in acute and chronic heart failure
Time frame: 12 months
Relationship between clinical, laboratory, and echocardiographic biomarkers with short- and long-term prognosis of patients
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Derived from this study: PubMed 41468984Anastasiou V, Stavropoulou E, Peteinidou E, Nikolaidou A, Daios S, Fardoulis E, Karamitsos T, Giannakoulas G, Naka KKappa, Delgado V, Ziakas A, Kamperidis V. Dynamic Changes in Right Ventricular-Pulmonary Arterial Coupling During Acute Heart Failure Hospitalization: Prognostic Implications. Am J Cardiol. 2026 Mar 1;262:6-15. doi: 10.1016/j.amjcard.2025.12.010. Epub 2025 Dec 28.
- Derived from this study: PubMed 40562231Anastasiou V, Papazoglou AS, Daios S, Peteinidou E, Nikolaidou A, Fardoulis E, Didagelos M, Karamitsos T, Giannakoulas G, Delgado V, Ziakas A, Kamperidis V. Prognostic Role of Right Atrial Reservoir Strain in Acute Heart Failure. Can J Cardiol. 2025 Oct;41(10):2085-2095. doi: 10.1016/j.cjca.2025.06.010. Epub 2025 Jun 23.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Vasileios Kamperidis, MD, MSc, PhD study director
School of Medicine, Aristotle University of Thessaloniki
Antonios Ziakas, MD, PhD study chair
Information provided by (Responsible Party):
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Failure, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 6 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Contact Stylianos Daios, MD, MSc (6947529606 ext. +30, stylianoschrys.daios@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between different heart failure sub-groups and echocardiographic indices (time frame: 12 months). 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 NCT05573997, which also lists 2 linked publications.
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 31 Jul 2024.