Clinical trial NCT03009552: Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure
Official title: Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Decompensated Heart Failure
Keywords: speckle tracking echocardiography
strain
strain rate
torsion
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Decompensated heart failure

Brief summary: The overall objective of the study is to determine whether speckle tracking echocardiography presents additional prognostic value to the routine assessment (clinical and echocardiographic) in patients admitted with acute decompensated heart failure (ADHF) at the emergency department. Specific objectives: 1 - To evaluate the association between changes in the cardiac contractile mechanics (by serial measurements of strain, strain rate, displacement velocity, rotation and ventricular torsion) with clinical outcomes in ADHF. 2 - Evaluate the possible association of these parameters with biomarkers of neurohormonal activity, myocardial injury, fibrosis and myocardial remodeling, inflammatory activity, and cardiorenal syndrome.

Detailed description: ADHF syndromes comprise around one million of emergency admissions per year in the United States, and the number of cases tripled in the last three decades, currently representing the main cause of hospital admission in patients over the age of 65 years. A recent study showed that among patients with similar risk in the presentation of ADHF, those admitted and treated in the emergency (in attempt to get early discharge) have higher mortality rate than those treated by hospitalization. On the other hand, uncertainty about the clinical course can also result in prolonged and unnecessary hospitalizations, which burdens the health system and consumes resources. Thus, It is vital to carry out studies that bring a better understanding of the pathophysiology of ADHF and to determine new risk stratification tools in the emergency department. Echocardiography is the most widely used imaging method and has a key role in the diagnosis and management of patients with HF. However, some methodological limitations of conventional echocardiography cause low reproducibility and intra and inter-observer agreement for some parameters, reducing their prognostic ability. In recent years, new technologies have been incorporated into the method in an attempt to overcome these limitations. One of these new technologies is echocardiography with "speckle tracking". The method, by its nature, has a significant advantage over parameters derived from conventional echocardiography, because of its ultrasound beam angle-independence. However, there is a paucity of data on this new technology in patients with ADHF in literature and we have not found studies evaluating the prognostic value of this method in a prospective cohort of patients in this condition. This study aims to develop knowledge of this assessment tool for cardiac mechanics in emergency care, exploring its potential prognostic value in patients with ADHF, aiming to assist the cardiologist in identifying eligible patients for early and safe discharge, and to identify those patients for whom hospitalization and longer treatment are recommended.

Eligibility criteria: Inclusion Criteria:

* Admission in the emergency for decompensated heart failure.

Exclusion Criteria:

* Systolic blood pressure \< 85, need surgical treatment, high ventricular frequency atrial fibrillation or flutter, severe pulmonary disease, pulmonary embolism, septic shock, advanced malignant neoplasia, pregnancy, heart transplant.

Primary outcomes:
measure: Composite endpoint of mortality, heart transplant, left ventricular assist device and readmission for decompensated heart failure.
timeFrame: Six months after admission
Secondary outcomes:
measure: Development of cardio-renal syndrome (loss of more than 30% of calculated creatinine clearance or need for dialysis)
timeFrame: 1 month after admission
measure: Cardiac mortality
timeFrame: 6 months
Other outcomes:
measure: Changes in left ventricle strain
timeFrame: 72 hours after admission
measure: Changes in left ventricle strain rate
timeFrame: 72 hours after admission
measure: Changes in left ventricle torsion
timeFrame: 72 hours after admission
measure: Changes in left ventricle ejection fraction
timeFrame: 72 hours after admission
measure: Changes in left atrial strain
timeFrame: 72 hours after admission
measure: Changes in left atrial strain rate
timeFrame: 72 hours after admission
measure: Changes in left atrial volume
timeFrame: 72 hours after admission
measure: Changes in right ventricle longitudinal strain
timeFrame: 72 hours after admission
measure: Changes in right ventricle longitudinal strain rate
timeFrame: 72 hours after admission
measure: Changes in right ventricle fractional area change
timeFrame: 72 hours after admission
measure: Changes in right ventricle performance index
timeFrame: 72 hours after admission
measure: Changes in right ventricle contraction-pressure index
timeFrame: 72 hours after admission
measure: Changes in right ventricle load adaptation index
timeFrame: 72 hours after admission
measure: Changes in tricuspid annular plane systolic excursion
timeFrame: 72 hours after admission
measure: Changes in tricuspid tissue Doppler peak systolic velocity (s´)
timeFrame: 72 hours after admission
measure: Changes in biventricular strain index
timeFrame: 72 hours after admission
measure: Serum level of B-type natriuretic peptide (BNP)
timeFrame: 72 hours after admission
measure: Serum levels of troponin
timeFrame: 72 hours after admission
measure: Serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)
timeFrame: 72 hours after admission
measure: Serum levels of galectin-3
timeFrame: 72 hours after admission
measure: Serum levels of C-reactive protein
timeFrame: 72 hours after admission
Locations:
city: Sao Paulo
country: Brazil
facility: CEPEC - Centro de pesquisas em ecocardiografia e cardiologia
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Marco Stephan L Alves, MD
role: PRINCIPAL_INVESTIGATOR
References: