Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure

NCT ID: NCT03009552

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 176 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-12-31

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.

Conditions

Decompensated Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marco Stephan Lofrano Alves

OTHER

Sponsor Role: lead

Responsible Party

Marco Stephan Lofrano Alves

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marco Stephan L Alves, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

CEPEC - Centro de pesquisas em ecocardiografia e cardiologia

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Marco Stephan L Alves, MD

Role: CONTACT

mslalves@hotmail.com

+55 11 26615646

Marco Stephan L Alves, MD

Role: CONTACT

+55 11 26615646

Facility Contacts

Marco Stephan L Alves, MD

Role: primary

mslalves@hotmail.com

+55 11 981431512

Other Identifiers

2015/10005-5

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CAAE:59669416.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id