Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure (STRAIN-DHF)

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.

Study Overview

• Status: Unknown
• Conditions: Decompensated Heart Failure
• Intervention / Treatment: Procedure: speckle tracking echocardiography

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.

• Study Type: Observational
• Enrollment (Anticipated): 176

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil
      • Recruiting
      • CEPEC - Centro de pesquisas em ecocardiografia e cardiologia
      • Contact: Marco Stephan L Alves, MD; Phone Number: +55 11 981431512; Email: mslalves@hotmail.com
      • Sub-Investigator: Wilson Mathias Jr, MD-PhD
      • Sub-Investigator: Cassio CS Machado, MD
      • Sub-Investigator: Danilo B Moleta, MD
      • Principal Investigator: Marco S Lofrano-Alves, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Decompensated heart failure

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite endpoint of mortality, heart transplant, left ventricular assist device and readmission for decompensated heart failure.	Six months after admission

Secondary Outcome Measures

Outcome Measure	Time Frame
Development of cardio-renal syndrome (loss of more than 30% of calculated creatinine clearance or need for dialysis)	1 month after admission
Cardiac mortality	6 months

Other Outcome Measures

Outcome Measure	Time Frame
Changes in left ventricle strain	72 hours after admission
Changes in left ventricle strain rate	72 hours after admission
Changes in left ventricle torsion	72 hours after admission
Changes in left ventricle ejection fraction	72 hours after admission
Changes in left atrial strain	72 hours after admission
Changes in left atrial strain rate	72 hours after admission
Changes in left atrial volume	72 hours after admission
Changes in right ventricle longitudinal strain	72 hours after admission
Changes in right ventricle longitudinal strain rate	72 hours after admission
Changes in right ventricle fractional area change	72 hours after admission
Changes in right ventricle performance index	72 hours after admission
Changes in right ventricle contraction-pressure index	72 hours after admission
Changes in right ventricle load adaptation index	72 hours after admission
Changes in tricuspid annular plane systolic excursion	72 hours after admission
Changes in tricuspid tissue Doppler peak systolic velocity (s´)	72 hours after admission
Changes in biventricular strain index	72 hours after admission
Serum level of B-type natriuretic peptide (BNP)	72 hours after admission
Serum levels of troponin	72 hours after admission
Serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)	72 hours after admission
Serum levels of galectin-3	72 hours after admission
Serum levels of C-reactive protein	72 hours after admission

Collaborators and Investigators

• Sponsor: Marco Stephan Lofrano Alves
• Investigators: Principal Investigator: Marco Stephan L Alves, MD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: December 30, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: strain; speckle tracking echocardiography; strain rate; torsion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CAAE:59669416.0.0000.0068; 2015/10005-5 (Other Grant/Funding Number: Sao Paulo Research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No