Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure

Decompensated Heart Failure Clinical Trial

— STRAIN-DHF  

Official title:

Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03009552
• Other study ID #: CAAE:59669416.0.0000.0068
• Secondary ID: 2015/10005-5
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2016
• Last updated: December 30, 2016
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2016
• Source: University of Sao Paulo
• Contact: Marco Stephan L Alves, MD
• Phone: +55 11 26615646
• Email: mslalves[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Decompensated Heart Failure
• Heart Failure

Intervention

Procedure:
• speckle tracking echocardiography
Speckle tracking echocardiography is used for measuring parameters of cardiac mechanics: left ventricle strain and strain rate; left ventricle twist, untwist and torsion; left atrium strain and strain rate; right ventricle longitudinal strain and strain rate. Echocardiography will be performed within 24 hours of admission, 72 hours after admission and 1 month after discharge.

Locations

Country	Name	City	State
Brazil	CEPEC - Centro de pesquisas em ecocardiografia e cardiologia	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Marco Stephan Lofrano Alves

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in left ventricle strain		72 hours after admission	Yes
Other	Changes in left ventricle strain rate		72 hours after admission	No
Other	Changes in left ventricle torsion		72 hours after admission	No
Other	Changes in left ventricle ejection fraction		72 hours after admission	No
Other	Changes in left atrial strain		72 hours after admission	No
Other	Changes in left atrial strain rate		72 hours after admission	No
Other	Changes in left atrial volume		72 hours after admission	No
Other	Changes in right ventricle longitudinal strain		72 hours after admission	Yes
Other	Changes in right ventricle longitudinal strain rate		72 hours after admission	Yes
Other	Changes in right ventricle fractional area change		72 hours after admission	No
Other	Changes in right ventricle performance index		72 hours after admission	No
Other	Changes in right ventricle contraction-pressure index		72 hours after admission	No
Other	Changes in right ventricle load adaptation index		72 hours after admission	No
Other	Changes in tricuspid annular plane systolic excursion		72 hours after admission	No
Other	Changes in tricuspid tissue Doppler peak systolic velocity (s´)		72 hours after admission	No
Other	Changes in biventricular strain index		72 hours after admission	No
Other	Serum level of B-type natriuretic peptide (BNP)		72 hours after admission	No
Other	Serum levels of troponin		72 hours after admission	No
Other	Serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)		72 hours after admission	No
Other	Serum levels of galectin-3		72 hours after admission	No
Other	Serum levels of C-reactive protein		72 hours after admission	No
Primary	Composite endpoint of mortality, heart transplant, left ventricular assist device and readmission for decompensated heart failure.		Six months after admission	Yes
Secondary	Development of cardio-renal syndrome (loss of more than 30% of calculated creatinine clearance or need for dialysis)		1 month after admission	Yes
Secondary	Cardiac mortality		6 months	Yes