Acute Heart FailureLEDANCT03048032
Lithuanian Echocardiography Study of Dyspnea in Acute Settings
An observational study of Acute Heart Failure, run by Vilnius University at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Blood sampling and Echocardiography exam
- Type of treatment
- Surgery or procedure
- How many people
- 1,566 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2015to Nov 2018
- 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: Adult patients (18 years and older) who present to the hospital (Vilnius University hospital Santariškių Klinikos and Hospital of Lithuanian University of Health Sciences Kauno Klinikos) due to acute dyspnea. Besides acute heart failure, patients with pulmonary causes of dyspnea as well as pulmonary embolism, acute infections, cancer and other reasons are enrolled. Patients admitted to the ward as well as and discharged home from the emergency department are enrolled.
Who may be able to join
- presentation to hospital with acute dyspnea.
Who cannot join
- refusal to give informed consent; acute coronary syndromes.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Lithuania2 sites
Lithuanian University of Health Sciences
Kaunas, 50009
Vilnius University
Vilnius, 08406
About this study
Official title: Diagnostic and Prognostic Value of Cardiac Biomarkers and Echocardiography for Patients Hospitalized Due to Acute Dyspnea: Prospective Observational Multicenter Cohort Study
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.
Read the 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:
- in-hospital all-cause mortality
- post-discharge 1 and 3 months all-cause mortality and rehospitalization
- post-discharge 1 and 3 months cardiovascular mortality and rehospitalization
- one-year cardiovascular mortality and rehospitalization.
Objectives of this project are:
- 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;
- 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;
- 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;
- To evaluate the epidemiology of RVF together with clinical features and outcome of patients in a cohort of Lithuanian acute heart failure (HF) patients;
- 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;
- To identify novel ultrasound parameters of RV structure and function parameters and biomarkers predicting a risk of 1 year mortality after hospitalization;
- 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.
- Conditions
- Acute Heart Failure
- Being tested
- Blood sampling, Echocardiography exam
- Keywords
- acute heart failure, right ventricular failure, cardiac biomarkers, echocardiography, diagnosis, prognosis
- Medical subject headings
- Heart Failure, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Besides routine clinical, laboratory and instrumental evaluation, blood samples will be taken within 4 hours of presentation to the hospital. Plasma samples, stored and frozen at -80°C, will be analyzed at the INSERM UMR942 institute in Paris. Up to 15 novel will be measured during the study: copeptine, proenkephalin, high sensitivity troponin T, troponin I, brain natriuretic peptide (BNP), N-terminal pro-BNP, adrenomedullin, soluble ST2, galectine 3, C-reactive protein, interleukine 6, procalcitonin, cystatin C, neutrophil gelatinase associated lipocalin.
Echocardiography examProcedure or surgery
A standard echocardiography as well as examination focused on right ventricle (RV) will be performed in a period of 48 hours of admission. Novel qualitative and quantitative parameters of right ventricle function and structure will be measured. These include RV diameter at base and midlevel, a measure of RV fractional area change (FAC), tissue doppler imaging derived tricuspid lateral annular systolic velocity wave (S'), tricuspid annular plane systolic excursion (TAPSE), velocity and gradient of tricuspid regurgitation, estimated systolic RV and RA pressure, RV wall strain and strain rate.
| Study group | Role | What they receive |
|---|---|---|
| Acute heart failure patients | Adult patients (18 years and older) who are admitted to the emergency department (Vilnius University Hospital Santariškių Klinikos and Hospital of Lithuanian University of Health Sciences Kauno Klinikos) due to acute dyspnea and have an adjudicated diagnosis of acute heart failure. Blood sampling and echocardiography examination will be performed. Receives: Procedure: Blood sampling; Procedure: Echocardiography exam | |
| Control group | Patients who are admitted to the emergency departments of participating centers due to acute dyspnea with an adjudicated diagnosis other than heart failure (pulmonary causes of dyspnea such as pulmonary embolism, acute infections, cancer and other reasons). Blood sampling and echocardiography examination will be performed. Receives: Procedure: Blood sampling; Procedure: Echocardiography exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year all-cause mortality and rehospitalization
The sum of all-cause deaths and all-cause rehospitalizations in AHF and non-AHF groups
Measured: 1 year
Secondary outcomes (4)
In-hospital all-cause mortality
All-cause deaths before discharge in AHF and non-AHF groups
Measured: 28 days
Post-discharge all-cause mortality and rehospitalization
The sum of all-cause deaths and all-cause rehospitalizations in AHF and non-AHF groups in 1 and 3 months minus Outcome 2
Measured: 1 and 3 months
Post-discharge cardiovascular mortality and rehospitalization
The sum of cardiovascular deaths and cardiovascular rehospitalizations in AHF and non-AHF groups in 1 and 3 months minus Outcome 2
Measured: 1 and 3 months
1-year cardiovascular mortality and rehospitalization
The sum of cardiovascular deaths and cardiovascular rehospitalizations in AHF and non-AHF groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startApr 2015
- Primary completionDec 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies 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
- Prospective
- Enrolment
- 1,566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Lithuanian University of Health Sciences
- Responsible party
- Principal investigator, Jelena Čelutkienė, Vilnius University
- Investigators
- Jelena Celutkiene, Professor, Study chair, Vilnius UniversityAusra Kavoliuniene, Professor, Principal investigator, Lithuanian University of Health SciencesAlexandre Mebazaa, Professor, Principal investigator, INSERM, BIOmarkers in CArdioNeuroVAScular diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048032
- Sponsor's protocol ID
- MIP-049/2015
- Other IDs
- MIP-049/2015, L-15-01/1
- Acronym
- LEDA
- Status last verified
- Nov 2018
- First submitted
- 2 Feb 2017
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be made available to other researchers via GREAT (Global REsearch on Acute Conditions Team) database
Publications
Kaur M, Sprague S, Ignacy T, Thoma A, Bhandari M, Farrokhyar F. How to optimize participant retention and complete follow-up in surgical research. Can J Surg. 2014 Dec;57(6):420-7. doi: 10.1503/cjs.006314. No abstract available.
PubMed 25421086Lasagna L. Problems in publication of clinical trial methodology. Clin Pharmacol Ther. 1979 May;25(5 Pt 2):751-3. doi: 10.1002/cpt1979255part2751.
PubMed 373967Gullen WH, Bearman JE, Calvert JC, Loewenson RB. Medical statistics: unscrambling the clinical research egg. Patient Care. 1978 May 30;12(10):120-2, 127, 130-2 passim. No abstract available.
PubMed 10236742Julious SA, Owen RJ. Sample size calculations for clinical studies allowing for uncertainty about the variance. Pharm Stat. 2006 Jan-Mar;5(1):29-37. doi: 10.1002/pst.197.
PubMed 17080926Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
PubMed 27207191Zannad F, Mebazaa A, Juilliere Y, Cohen-Solal A, Guize L, Alla F, Rouge P, Blin P, Barlet MH, Paolozzi L, Vincent C, Desnos M, Samii K; EFICA Investigators. Clinical profile, contemporary management and one-year mortality in patients with severe acute heart failure syndromes: The EFICA study. Eur J Heart Fail. 2006 Nov;8(7):697-705. doi: 10.1016/j.ejheart.2006.01.001. Epub 2006 Mar 3.
PubMed 16516552Maisel AS, Peacock WF, McMullin N, Jessie R, Fonarow GC, Wynne J, Mills RM. Timing of immunoreactive B-type natriuretic peptide levels and treatment delay in acute decompensated heart failure: an ADHERE (Acute Decompensated Heart Failure National Registry) analysis. J Am Coll Cardiol. 2008 Aug 12;52(7):534-40. doi: 10.1016/j.jacc.2008.05.010.
PubMed 18687247Emerman CL. Treatment of the acute decompensation of heart failure: efficacy and pharmacoeconomics of early initiation of therapy in the emergency department. Rev Cardiovasc Med. 2003;4 Suppl 7:S13-20.
PubMed 14668696Peacock WF, Emerman C, Costanzo MR, Diercks DB, Lopatin M, Fonarow GC. Early vasoactive drugs improve heart failure outcomes. Congest Heart Fail. 2009 Nov-Dec;15(6):256-64. doi: 10.1111/j.1751-7133.2009.00112.x.
PubMed 19925503Masip J, Roque M, Sanchez B, Fernandez R, Subirana M, Exposito JA. Noninvasive ventilation in acute cardiogenic pulmonary edema: systematic review and meta-analysis. JAMA. 2005 Dec 28;294(24):3124-30. doi: 10.1001/jama.294.24.3124.
PubMed 16380593Maisel AS, McCord J, Nowak RM, Hollander JE, Wu AH, Duc P, Omland T, Storrow AB, Krishnaswamy P, Abraham WT, Clopton P, Steg G, Aumont MC, Westheim A, Knudsen CW, Perez A, Kamin R, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Bedside B-Type natriuretic peptide in the emergency diagnosis of heart failure with reduced or preserved ejection fraction. Results from the Breathing Not Properly Multinational Study. J Am Coll Cardiol. 2003 Jun 4;41(11):2010-7. doi: 10.1016/s0735-1097(03)00405-4.
PubMed 12798574Januzzi JL Jr, Camargo CA, Anwaruddin S, Baggish AL, Chen AA, Krauser DG, Tung R, Cameron R, Nagurney JT, Chae CU, Lloyd-Jones DM, Brown DF, Foran-Melanson S, Sluss PM, Lee-Lewandrowski E, Lewandrowski KB. The N-terminal Pro-BNP investigation of dyspnea in the emergency department (PRIDE) study. Am J Cardiol. 2005 Apr 15;95(8):948-54. doi: 10.1016/j.amjcard.2004.12.032.
PubMed 15820160Peacock WF 4th, De Marco T, Fonarow GC, Diercks D, Wynne J, Apple FS, Wu AH; ADHERE Investigators. Cardiac troponin and outcome in acute heart failure. N Engl J Med. 2008 May 15;358(20):2117-26. doi: 10.1056/NEJMoa0706824.
PubMed 18480204Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.
PubMed 23186936Chioncel O, Ambrosy AP, Bubenek S, Filipescu D, Vinereanu D, Petris A, Christodorescu R, Macarie C, Gheorghiade M, Collins SP; Romanian Acute Heart Failure Syndromes study investigators. Epidemiology, pathophysiology, and in-hospital management of pulmonary edema: data from the Romanian Acute Heart Failure Syndromes registry. J Cardiovasc Med (Hagerstown). 2016 Feb;17(2):92-104. doi: 10.2459/JCM.0000000000000192.
PubMed 25252041
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Value of Cardiac Biomarkers and Echocardiography for Patients Hospitalized Due to Acute Dyspnea: Prospective Observational Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT03048032
- Acronym / sponsor ID
- LEDA / MIP-049/2015
- Conditions
- Acute Heart Failure
- Keywords
- acute heart failure, right ventricular failure, cardiac biomarkers, echocardiography, diagnosis, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,566 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Lithuanian University of Health Sciences
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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.
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.
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:
- in-hospital all-cause mortality
- post-discharge 1 and 3 months all-cause mortality and rehospitalization
- post-discharge 1 and 3 months cardiovascular mortality and rehospitalization
- one-year cardiovascular mortality and rehospitalization.
Objectives of this project are:
- 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;
- 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;
- 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;
- To evaluate the epidemiology of RVF together with clinical features and outcome of patients in a cohort of Lithuanian acute heart failure (HF) patients;
- 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;
- To identify novel ultrasound parameters of RV structure and function parameters and biomarkers predicting a risk of 1 year mortality after hospitalization;
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute heart failure patients | – | Procedure: Blood sampling, Procedure: Echocardiography examAdult patients (18 years and older) who are admitted to the emergency department (Vilnius University Hospital Santariškių Klinikos and Hospital of Lithuanian University of Health Sciences Kauno Klinikos) due to acute dyspnea and have an adjudicated diagnosis of acute heart failure. Blood sampling and echocardiography examination will be performed. |
| Control group | – | Procedure: Blood sampling, Procedure: Echocardiography examPatients who are admitted to the emergency departments of participating centers due to acute dyspnea with an adjudicated diagnosis other than heart failure (pulmonary causes of dyspnea such as pulmonary embolism, acute infections, cancer and other reasons). Blood sampling and echocardiography examination will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18 years and older) who present to the hospital (Vilnius University hospital Santariškių Klinikos and Hospital of Lithuanian University of Health Sciences Kauno Klinikos) due to acute dyspnea. Besides acute heart failure, patients with pulmonary causes of dyspnea as well as pulmonary embolism, acute infections, cancer and other reasons are enrolled. Patients admitted to the ward as well as and discharged home from the emergency department are enrolled.
Key inclusion criteria (1 listed)
- presentation to hospital with acute dyspnea.
Key exclusion criteria (1 listed)
- refusal to give informed consent; acute coronary syndromes.
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 |
|---|---|---|
| Blood samplingBesides routine clinical, laboratory and instrumental evaluation, blood samples will be taken within 4 hours of presentation to the hospital. Plasma samples, stored and frozen at -80°C, will be analyzed at the INSERM UMR942 institute in Paris. Up to 15 novel will be measured during the study: copeptine, proenkephalin, high sensitivity troponin T, troponin I, brain natriuretic peptide (BNP), N-terminal pro-BNP, adrenomedullin, soluble ST2, galectine 3, C-reactive protein, interleukine 6, procalcitonin, cystatin C, neutrophil gelatinase associated lipocalin. | Procedure or surgery | Acute heart failure patients, Control group |
| Echocardiography examA standard echocardiography as well as examination focused on right ventricle (RV) will be performed in a period of 48 hours of admission. Novel qualitative and quantitative parameters of right ventricle function and structure will be measured. These include RV diameter at base and midlevel, a measure of RV fractional area change (FAC), tissue doppler imaging derived tricuspid lateral annular systolic velocity wave (S'), tricuspid annular plane systolic excursion (TAPSE), velocity and gradient of tricuspid regurgitation, estimated systolic RV and RA pressure, RV wall strain and strain rate. | Procedure or surgery | Acute heart failure patients, Control group |
Primary outcome
1-year all-cause mortality and rehospitalization
Time frame: 1 year
The sum of all-cause deaths and all-cause rehospitalizations in AHF and non-AHF groups
4 secondary outcomes
In-hospital all-cause mortality
Time frame: 28 days
Post-discharge all-cause mortality and rehospitalization
Time frame: 1 and 3 months
Post-discharge cardiovascular mortality and rehospitalization
Time frame: 1 and 3 months
1-year cardiovascular mortality and rehospitalization
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Background: PubMed 25421086Kaur M, Sprague S, Ignacy T, Thoma A, Bhandari M, Farrokhyar F. How to optimize participant retention and complete follow-up in surgical research. Can J Surg. 2014 Dec;57(6):420-7. doi: 10.1503/cjs.006314. No abstract available.
- Background: PubMed 373967Lasagna L. Problems in publication of clinical trial methodology. Clin Pharmacol Ther. 1979 May;25(5 Pt 2):751-3. doi: 10.1002/cpt1979255part2751.
- Background: PubMed 10236742Gullen WH, Bearman JE, Calvert JC, Loewenson RB. Medical statistics: unscrambling the clinical research egg. Patient Care. 1978 May 30;12(10):120-2, 127, 130-2 passim. No abstract available.
- Background: PubMed 17080926Julious SA, Owen RJ. Sample size calculations for clinical studies allowing for uncertainty about the variance. Pharm Stat. 2006 Jan-Mar;5(1):29-37. doi: 10.1002/pst.197.
- Background: PubMed 27207191Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
- Background: PubMed 16516552Zannad F, Mebazaa A, Juilliere Y, Cohen-Solal A, Guize L, Alla F, Rouge P, Blin P, Barlet MH, Paolozzi L, Vincent C, Desnos M, Samii K; EFICA Investigators. Clinical profile, contemporary management and one-year mortality in patients with severe acute heart failure syndromes: The EFICA study. Eur J Heart Fail. 2006 Nov;8(7):697-705. doi: 10.1016/j.ejheart.2006.01.001. Epub 2006 Mar 3.
- Background: PubMed 18687247Maisel AS, Peacock WF, McMullin N, Jessie R, Fonarow GC, Wynne J, Mills RM. Timing of immunoreactive B-type natriuretic peptide levels and treatment delay in acute decompensated heart failure: an ADHERE (Acute Decompensated Heart Failure National Registry) analysis. J Am Coll Cardiol. 2008 Aug 12;52(7):534-40. doi: 10.1016/j.jacc.2008.05.010.
- Background: PubMed 14668696Emerman CL. Treatment of the acute decompensation of heart failure: efficacy and pharmacoeconomics of early initiation of therapy in the emergency department. Rev Cardiovasc Med. 2003;4 Suppl 7:S13-20.
- Background: PubMed 19925503Peacock WF, Emerman C, Costanzo MR, Diercks DB, Lopatin M, Fonarow GC. Early vasoactive drugs improve heart failure outcomes. Congest Heart Fail. 2009 Nov-Dec;15(6):256-64. doi: 10.1111/j.1751-7133.2009.00112.x.
- Background: PubMed 16380593Masip J, Roque M, Sanchez B, Fernandez R, Subirana M, Exposito JA. Noninvasive ventilation in acute cardiogenic pulmonary edema: systematic review and meta-analysis. JAMA. 2005 Dec 28;294(24):3124-30. doi: 10.1001/jama.294.24.3124.
- Background: PubMed 12798574Maisel AS, McCord J, Nowak RM, Hollander JE, Wu AH, Duc P, Omland T, Storrow AB, Krishnaswamy P, Abraham WT, Clopton P, Steg G, Aumont MC, Westheim A, Knudsen CW, Perez A, Kamin R, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Bedside B-Type natriuretic peptide in the emergency diagnosis of heart failure with reduced or preserved ejection fraction. Results from the Breathing Not Properly Multinational Study. J Am Coll Cardiol. 2003 Jun 4;41(11):2010-7. doi: 10.1016/s0735-1097(03)00405-4.
- Background: PubMed 15820160Januzzi JL Jr, Camargo CA, Anwaruddin S, Baggish AL, Chen AA, Krauser DG, Tung R, Cameron R, Nagurney JT, Chae CU, Lloyd-Jones DM, Brown DF, Foran-Melanson S, Sluss PM, Lee-Lewandrowski E, Lewandrowski KB. The N-terminal Pro-BNP investigation of dyspnea in the emergency department (PRIDE) study. Am J Cardiol. 2005 Apr 15;95(8):948-54. doi: 10.1016/j.amjcard.2004.12.032.
- Individual participant dataSharing planned: Yes. Individual participant data will be made available to other researchers via GREAT (Global REsearch on Acute Conditions Team) database
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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.
Jelena Celutkiene, Professor study chair
Vilnius University
Ausra Kavoliuniene, Professor principal investigator
Lithuanian University of Health Sciences
Alexandre Mebazaa, Professor principal investigator
INSERM, BIOmarkers in CArdioNeuroVAScular diseases
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by Vilnius University at 3 sites in 2 countries.
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 1 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: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Lithuania, France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1-year all-cause mortality and rehospitalization (time frame: 1 year). 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 NCT03048032, which also lists 63 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 23 Nov 2018.