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

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Marco Stephan Lofrano Alves, University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Marco Stephan Lofrano Alves, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT03009552
First received: December 28, 2016
Last updated: December 30, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
Decompensated Heart Failure Procedure: speckle tracking echocardiography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure

Resource links provided by NLM:


Further study details as provided by Marco Stephan Lofrano Alves, University of Sao Paulo:

Primary Outcome Measures:
  • Composite endpoint of mortality, heart transplant, left ventricular assist device and readmission for decompensated heart failure. [ Time Frame: Six months after admission ]

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

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

Estimated Enrollment: 176
Study Start Date: June 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Decompensated heart failure
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03009552

Contacts
Contact: Marco Stephan L Alves, MD +55 11 26615646 mslalves@hotmail.com
Contact: Marco Stephan L Alves, MD +55 11 26615646

Locations
Brazil
CEPEC - Centro de pesquisas em ecocardiografia e cardiologia Recruiting
Sao Paulo, SP, Brazil
Contact: Marco Stephan L Alves, MD    +55 11 981431512    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         
Sponsors and Collaborators
Marco Stephan Lofrano Alves
Investigators
Principal Investigator: Marco Stephan L Alves, MD University of Sao Paulo
  More Information

Responsible Party: Marco Stephan Lofrano Alves, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03009552     History of Changes
Other Study ID Numbers: CAAE:59669416.0.0000.0068
2015/10005-5 ( Other Grant/Funding Number: Sao Paulo Research Foundation )
Study First Received: December 28, 2016
Last Updated: December 30, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marco Stephan Lofrano Alves, University of Sao Paulo:
speckle tracking echocardiography
strain
strain rate
torsion

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 19, 2017