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

December 30, 2016 updated by: Marco Stephan Lofrano Alves
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Marco Stephan L Alves, MD
  • Phone Number: +55 11 26615646

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • Recruiting
        • CEPEC - Centro de pesquisas em ecocardiografia e cardiologia
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite endpoint of mortality, heart transplant, left ventricular assist device and readmission for decompensated heart failure.
Time Frame: Six months after admission
Six months after admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Development of cardio-renal syndrome (loss of more than 30% of calculated creatinine clearance or need for dialysis)
Time Frame: 1 month after admission
1 month after admission
Cardiac mortality
Time Frame: 6 months
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Changes in left ventricle strain
Time Frame: 72 hours after admission
72 hours after admission
Changes in left ventricle strain rate
Time Frame: 72 hours after admission
72 hours after admission
Changes in left ventricle torsion
Time Frame: 72 hours after admission
72 hours after admission
Changes in left ventricle ejection fraction
Time Frame: 72 hours after admission
72 hours after admission
Changes in left atrial strain
Time Frame: 72 hours after admission
72 hours after admission
Changes in left atrial strain rate
Time Frame: 72 hours after admission
72 hours after admission
Changes in left atrial volume
Time Frame: 72 hours after admission
72 hours after admission
Changes in right ventricle longitudinal strain
Time Frame: 72 hours after admission
72 hours after admission
Changes in right ventricle longitudinal strain rate
Time Frame: 72 hours after admission
72 hours after admission
Changes in right ventricle fractional area change
Time Frame: 72 hours after admission
72 hours after admission
Changes in right ventricle performance index
Time Frame: 72 hours after admission
72 hours after admission
Changes in right ventricle contraction-pressure index
Time Frame: 72 hours after admission
72 hours after admission
Changes in right ventricle load adaptation index
Time Frame: 72 hours after admission
72 hours after admission
Changes in tricuspid annular plane systolic excursion
Time Frame: 72 hours after admission
72 hours after admission
Changes in tricuspid tissue Doppler peak systolic velocity (s´)
Time Frame: 72 hours after admission
72 hours after admission
Changes in biventricular strain index
Time Frame: 72 hours after admission
72 hours after admission
Serum level of B-type natriuretic peptide (BNP)
Time Frame: 72 hours after admission
72 hours after admission
Serum levels of troponin
Time Frame: 72 hours after admission
72 hours after admission
Serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)
Time Frame: 72 hours after admission
72 hours after admission
Serum levels of galectin-3
Time Frame: 72 hours after admission
72 hours after admission
Serum levels of C-reactive protein
Time Frame: 72 hours after admission
72 hours after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marco Stephan Lofrano Alves

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marco Stephan L Alves, MD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Decompensated Heart Failure

Clinical Trials on speckle tracking echocardiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings