Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure

NCT03009552 | Unknown DMC

• 2 other identifiers: CAAE:59669416.0.0000.00682015/10005-5
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Decompensated Heart Failure

Keywords

speckle tracking echocardiography; strain; strain rate; torsion

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of mortality, heart transplant, left ventricular assist device and readmission for decompensated heart failure.

  Six months after admission

Secondary Outcomes (2)

• 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 Outcomes (21)

• 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

Interventions

speckle tracking echocardiography PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Decompensated heart failure

You may qualify if:

• Admission in the emergency for decompensated heart failure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marco Stephan Lofrano Alves: lead

Study Sites (1)

CEPEC - Centro de pesquisas em ecocardiografia e cardiologia

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Marco Stephan L Alves, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Stephan L Alves, MD

CONTACT

+55 11 26615646; mslalves@hotmail.com

Marco Stephan L Alves, MD

CONTACT

+55 11 26615646

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 4, 2017
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: January 4, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)