Ignite Creation Date:
2024-05-06 @ 9:41 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03048032
Status:
COMPLETED
Last Update Posted:
2018-11-23
First Post:
2017-02-02
Brief Title:
Lithuanian Echocardiography Study of Dyspnea in Acute Settings
Sponsor:
Vilnius University
Organization:
Vilnius University
Study Overview
Official Title:
Diagnostic and Prognostic Value of Cardiac Biomarkers and Echocardiography for Patients Hospitalized Due to Acute Dyspnea Prospective Observational Multicenter Cohort Study
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEDA
Brief Summary:
LEDA Lithuanian Echocardiography study of Dyspnea in Acute settings is a prospective observational cohort multicenter clinical study Project is carried out by Vilnius University together with a partner Lithuanian University of Health Sciences in conjunction with a research protocol of international GREAT consortium Global Research on Acute Conditions Team The aim of this project is to find the specific novel biomarkers of acute heart failure AHF to evaluate their diagnostic and prognostic role in association with echocardiographic parameters of AHF Primary endpoint is 1-year all-cause mortality and rehospitalization Secondary endpoints are 1 in-hospital all-cause mortality 2 post-discharge 1 and 3 month all-cause mortality and rehospitalization 3 post-discharge 1 and 3 month cardiovascular mortality and rehospitalization 4 one-year cardiovascular mortality and rehospitalization
During the project a sizeable national database 2000 Lithuanian patients will be integrated into database of GREAT network Novel cardiac biomarkers together with ultrasound parameters of right ventricular RV function are in the focus of the study During the acute phase of heart failure up to 15 novel cardiac vascular renal impairment and inflammation biomarkers in plasma samples will be investigated in Lithuania and France INSERM laboratory Plasma samples will be taken during 4 hours after admission and frozen at -80ºC to allow batch analysis The extensive evaluation of innovative ultrasound parameters of right ventricular structure and function will be performed in the early hospitalization period along with standard echocardiography examination The first database of AHF patients in Lithuania will provide demographic data and trends of morbidity and mortality as well as analysis of diagnostic and prognostic value of novel biomarkers and echocardiography parameters in the Baltic region Quantitative parameters of RV systolic function and deformation will be measured It is expected that optimal use of novel biomarkers and reproducible echocardiography parameters in the setting of emergency and critical care would reduce unnecessary hospitalizations cost and hospital length of stay without decrease in the quality of diagnostics and treatment An estimation of correlation of echocardiographic parameters and biomarkers could help create an accurate algorithm for risk stratification and diagnosis of AHF in an emergency setting
During the project a sizeable national database 2000 Lithuanian patients will be integrated into database of GREAT network Novel cardiac biomarkers together with ultrasound parameters of right ventricular RV function are in the focus of the study During the acute phase of heart failure up to 15 novel cardiac vascular renal impairment and inflammation biomarkers in plasma samples will be investigated in Lithuania and France INSERM laboratory Plasma samples will be taken during 4 hours after admission and frozen at -80ºC to allow batch analysis The extensive evaluation of innovative ultrasound parameters of right ventricular structure and function will be performed in the early hospitalization period along with standard echocardiography examination The first database of AHF patients in Lithuania will provide demographic data and trends of morbidity and mortality as well as analysis of diagnostic and prognostic value of novel biomarkers and echocardiography parameters in the Baltic region Quantitative parameters of RV systolic function and deformation will be measured It is expected that optimal use of novel biomarkers and reproducible echocardiography parameters in the setting of emergency and critical care would reduce unnecessary hospitalizations cost and hospital length of stay without decrease in the quality of diagnostics and treatment An estimation of correlation of echocardiographic parameters and biomarkers could help create an accurate algorithm for risk stratification and diagnosis of AHF in an emergency setting
Detailed Description:
Heart failure HF is believed to be the modern-day epidemic due to increasing incidence impaired long-term prognosis and huge economic burden With the ageing population the impact of HF on health care resources is on the rise The course of the disease is characterized by episodes of acute decompensation that mark a significant turning point in the progress of the disease with in-hospital mortality rates as high as 10 Acute heart failure AHF is a gradual or rapid change in HF signs and symptoms requiring urgent medical therapies Acute heart failure is estimated to be the most costly and the most frequent cause of admission to emergency wards Emergency department ED is the primary setting where initial AHF management takes place However strong evidence for diagnostics and management of this grave condition is still lacking Even less is known about the prevalence diagnosis and management of acute right ventricular failure RVF
A patient presenting to the ED with acute dyspnea has to undergo numerous procedures in order to differentiate the diagnosis between AHF chronic obstructive pulmonary disease pneumonia pulmonary embolism and other etiologies Moreover the majority of HF patients suffer from comorbidities that make the diagnostic process even more challenging Due to numerous exams and tests the initial management of these patients may be delayed resulting in an extended hospital length of stay increased rate of complications and death The clinical hemodynamic and neurohormonal features of heart failure are different in specific patient populations and depend on age sex race left ventricular ejection fraction and co-existent right ventricular RV dysfunction as well as many other factors
Cardiac biomarkers are easily reproducible and objective laboratory tests that could help to improve early AHF diagnosis and risk stratification However reported data suggest varying prognostic and diagnostic values of natriuretic peptides such as N-type natriuretic peptide BNP N-terminal pro B-type natriuretic peptide NT-proBNP MR pro-atrial natriuretic peptide MR-proANP as well as regional differences of these markers Specific biomarkers of RVF have not yet been described thus a search of novel serologic markers that could rapidly and reliably help diagnose acute RVF is a very important scientific task in cardiology Furthermore the knowledge on the incidence of RVF syndrome as well as the diagnostic and prognostic values of ultrasound RV structural and functional parameters is scarce During this study the RV-focused ultrasound examination will be performed in the early hospitalization period and blood samples will be taken and frozen at the same time Up to 15 novel cardiac vascular renal impairment and inflammation biomarkers in plasma samples during acute phase of RVF will be investigated during the study in France INSERM laboratory The study will be unique as it will aggregate large scale observational and biomarkers database of AHF patients in Lithuania together with innovative ultrasound parameters of RV failure quantitative parameters of RV systolic function and deformation
The aim of this project is to find the specific novel biomarkers of acute heart failure AHF to evaluate their diagnostic and prognostic role in association with echocardiographic parameters of AHF
The primary endpoint is 1-year all-cause mortality and rehospitalization
Secondary endpoints are
1 in-hospital all-cause mortality
2 post-discharge 1 and 3 months all-cause mortality and rehospitalization
3 post-discharge 1 and 3 months cardiovascular mortality and rehospitalization
4 one-year cardiovascular mortality and rehospitalization
Objectives of this project are
1 To create a database of patients hospitalized due to acute heart failure in Lithuania integrated to GREAT Global Research on Acute Conditions Team network database
2 To compare the diagnostic and prognostic value of novel cardiac vascular renal insufficiency and inflammation biomarkers in the Lithuanian patient cohort to other countries in the GREAT network
3 To determine the demographic clinical and treatment characteristics as well as short and long term outcome of patients hospitalized due to AHF in Lithuania and other GREAT network countries
4 To evaluate the epidemiology of RVF together with clinical features and outcome of patients in a cohort of Lithuanian acute heart failure HF patients
5 To estimate a correlation between ultrasound parameters of RV structure and function and novel cardiac vascular renal and inflammation biomarkers in acute period of HF
6 To identify novel ultrasound parameters of RV structure and function parameters and biomarkers predicting a risk of 1 year mortality after hospitalization
7 To create an algorithm of RV failure diagnostics and risk stratification based on the diagnostic and prognostic value of detected echocardiographic parameters and biomarkers
Observational studies and recent meta-analyses indicate that in acute conditions RVF may be as frequent as let ventricular failure LVF and is associated with markedly poor prognosis Largely empiric knowledge in emergency medicine suggests that right and left ventricular failure requires different therapeutic approaches including disparate principles of intravenous treatment due to distinct hemodynamic impairment The outcome of RVF is largely dependent on the underlying cause resulting in either an acute or chronic presentation
Novel biomarkers can help identify the underlying conditions in AHF These include myocardial injury markers such as copeptine proenkephalin high sensitivity troponin T troponin I brain natriuretic peptide BNP N-terminal-proBNP renal and hepatic involvement markers such as adrenomedullin neutrophil gelatinase-associated lipocalin NGAL L-type fatty acid binding protein L-FABP galectin-3 soluble ST2 cystatin C inflammatory markers such as C-reactive protein interleukine 6 procalcitonin These markers could help evaluate end-organ involvement as well as the extent of myocardial remodeling and in return provide state-of-the-art tailored patient care Specific biomarkers of RV involvement or dysfunction have not yet been described therefore identification of such biomarkers would allow to accelerate the diagnosis of RVF and initiate specific treatment
Echocardiography is a potent and accessible technique for the diagnosis of AHF in an acute setting Echocardiography also provides information about the mechanisms of AHF as well as alternative causes of dyspnea Echocardiographic parameters of RV structure and function are of particular interest since not much data is available on acute RVF Quantitative parameters of RV systolic and diastolic function RV wall deformation or notional hemodynamic parameters could potentially be useful for diagnosis and selection of urgent treatment tactics In the current literature there are no publications about the diagnostic and prognostic value of RV parameters especially about novel echocardiographic parameters strain rate speckle tracking in the early phase of exacerbated heart failure
Global Research on Acute Conditions Teal GREAT Association is an international network among experts operating in the management of acute clinical conditions in the field of emergency medicine and doing research through the concept of translational medicine This network integrates research inputs from basic sciences and interventional epidemiology to optimize both patient care and preventive measures Moreover one of the main objectives of the GREAT association is to standardize the clinical and organizational system approach in acute conditions disease management all over the world with the concept of globalization medicine Up to this day there has not been any large multicenter observational and biomarkers studies in Lithuania in the field of AHF Our study creates a unique opportunity to join the worldwide GREAT network and its patient database that could potentially contain up to 50 000 patients
A patient presenting to the ED with acute dyspnea has to undergo numerous procedures in order to differentiate the diagnosis between AHF chronic obstructive pulmonary disease pneumonia pulmonary embolism and other etiologies Moreover the majority of HF patients suffer from comorbidities that make the diagnostic process even more challenging Due to numerous exams and tests the initial management of these patients may be delayed resulting in an extended hospital length of stay increased rate of complications and death The clinical hemodynamic and neurohormonal features of heart failure are different in specific patient populations and depend on age sex race left ventricular ejection fraction and co-existent right ventricular RV dysfunction as well as many other factors
Cardiac biomarkers are easily reproducible and objective laboratory tests that could help to improve early AHF diagnosis and risk stratification However reported data suggest varying prognostic and diagnostic values of natriuretic peptides such as N-type natriuretic peptide BNP N-terminal pro B-type natriuretic peptide NT-proBNP MR pro-atrial natriuretic peptide MR-proANP as well as regional differences of these markers Specific biomarkers of RVF have not yet been described thus a search of novel serologic markers that could rapidly and reliably help diagnose acute RVF is a very important scientific task in cardiology Furthermore the knowledge on the incidence of RVF syndrome as well as the diagnostic and prognostic values of ultrasound RV structural and functional parameters is scarce During this study the RV-focused ultrasound examination will be performed in the early hospitalization period and blood samples will be taken and frozen at the same time Up to 15 novel cardiac vascular renal impairment and inflammation biomarkers in plasma samples during acute phase of RVF will be investigated during the study in France INSERM laboratory The study will be unique as it will aggregate large scale observational and biomarkers database of AHF patients in Lithuania together with innovative ultrasound parameters of RV failure quantitative parameters of RV systolic function and deformation
The aim of this project is to find the specific novel biomarkers of acute heart failure AHF to evaluate their diagnostic and prognostic role in association with echocardiographic parameters of AHF
The primary endpoint is 1-year all-cause mortality and rehospitalization
Secondary endpoints are
1 in-hospital all-cause mortality
2 post-discharge 1 and 3 months all-cause mortality and rehospitalization
3 post-discharge 1 and 3 months cardiovascular mortality and rehospitalization
4 one-year cardiovascular mortality and rehospitalization
Objectives of this project are
1 To create a database of patients hospitalized due to acute heart failure in Lithuania integrated to GREAT Global Research on Acute Conditions Team network database
2 To compare the diagnostic and prognostic value of novel cardiac vascular renal insufficiency and inflammation biomarkers in the Lithuanian patient cohort to other countries in the GREAT network
3 To determine the demographic clinical and treatment characteristics as well as short and long term outcome of patients hospitalized due to AHF in Lithuania and other GREAT network countries
4 To evaluate the epidemiology of RVF together with clinical features and outcome of patients in a cohort of Lithuanian acute heart failure HF patients
5 To estimate a correlation between ultrasound parameters of RV structure and function and novel cardiac vascular renal and inflammation biomarkers in acute period of HF
6 To identify novel ultrasound parameters of RV structure and function parameters and biomarkers predicting a risk of 1 year mortality after hospitalization
7 To create an algorithm of RV failure diagnostics and risk stratification based on the diagnostic and prognostic value of detected echocardiographic parameters and biomarkers
Observational studies and recent meta-analyses indicate that in acute conditions RVF may be as frequent as let ventricular failure LVF and is associated with markedly poor prognosis Largely empiric knowledge in emergency medicine suggests that right and left ventricular failure requires different therapeutic approaches including disparate principles of intravenous treatment due to distinct hemodynamic impairment The outcome of RVF is largely dependent on the underlying cause resulting in either an acute or chronic presentation
Novel biomarkers can help identify the underlying conditions in AHF These include myocardial injury markers such as copeptine proenkephalin high sensitivity troponin T troponin I brain natriuretic peptide BNP N-terminal-proBNP renal and hepatic involvement markers such as adrenomedullin neutrophil gelatinase-associated lipocalin NGAL L-type fatty acid binding protein L-FABP galectin-3 soluble ST2 cystatin C inflammatory markers such as C-reactive protein interleukine 6 procalcitonin These markers could help evaluate end-organ involvement as well as the extent of myocardial remodeling and in return provide state-of-the-art tailored patient care Specific biomarkers of RV involvement or dysfunction have not yet been described therefore identification of such biomarkers would allow to accelerate the diagnosis of RVF and initiate specific treatment
Echocardiography is a potent and accessible technique for the diagnosis of AHF in an acute setting Echocardiography also provides information about the mechanisms of AHF as well as alternative causes of dyspnea Echocardiographic parameters of RV structure and function are of particular interest since not much data is available on acute RVF Quantitative parameters of RV systolic and diastolic function RV wall deformation or notional hemodynamic parameters could potentially be useful for diagnosis and selection of urgent treatment tactics In the current literature there are no publications about the diagnostic and prognostic value of RV parameters especially about novel echocardiographic parameters strain rate speckle tracking in the early phase of exacerbated heart failure
Global Research on Acute Conditions Teal GREAT Association is an international network among experts operating in the management of acute clinical conditions in the field of emergency medicine and doing research through the concept of translational medicine This network integrates research inputs from basic sciences and interventional epidemiology to optimize both patient care and preventive measures Moreover one of the main objectives of the GREAT association is to standardize the clinical and organizational system approach in acute conditions disease management all over the world with the concept of globalization medicine Up to this day there has not been any large multicenter observational and biomarkers studies in Lithuania in the field of AHF Our study creates a unique opportunity to join the worldwide GREAT network and its patient database that could potentially contain up to 50 000 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| L-15-011 | OTHER | Lithuanian Bioethics Commitee | None |
| MIP-0492015 | OTHER_GRANT | None | None |