Strain X Cardiopulmonary Test

August 11, 2016 updated by: Daniella Cunha Brandao

Analysis Of Strain Myocardial Associated With The Exercise Tolerance In Patients With Heart Failure Systolic

Introduction : Patients with heart failure (HF ) with systolic dysfunction of moderate to severe exhibit significant reduction in the ability to exercise compared to those with mild dysfunction , and have worse prognosis. However, some clinical markers of severity and diagnosis widely used in this population such as ejection fraction (EF) , are not always able to translate the actual degree of cardiac damage as well as their relationship with the cardiorespiratory fitness of these individuals and prognosis .

Objective: To evaluate the ability of the global longitudinal strain ( GLS ) in predicting exercise tolerance in heart failure patients with moderate and significant systolic dysfunction.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

26

Contacts and Locations

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

Study Locations

  • Brazil
    • PE
      • Recife, PE, Brazil
        • Recruiting
        • Universidade Federal de Pernmabuco
        • Contact:

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

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of adults 21-65 years diagnosed with HF of all etiologies , in functional class II and III by the New York Heart Association ( NYHA ) , sedentary , of both sexes.

Description

Inclusion Criteria:

  • moderate and significant systolic dysfunction (LVEF < 45%) assessed by transthoracic echocardiography recent ( last month before evaluation ) Teichholz method , or when in the presence of contractile deficit target , by the Simpson method.

Exclusion Criteria:

  • deformity in the face to prevent the coupling of the mask to perform the CPET ,
  • orthopedic and neurological diseases that could make it impossible to perform the tests ,
  • patients with psychiatric disorders that restricted them to respond to the questionnaire ,
  • HF FC IV or hospitalization in the last three months ,
  • angina unstable;
  • myocardial infarction or heart surgery up to three months before the survey ;
  • FEV1 / FVC <70 % predicted characterizing obstructive respiratory disorder .

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

  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiography for obtaining the "strain "
Time Frame: 1 day
To strain of technical analysis will be used echocardiography analysis software ( EchoPAC , GE Medical Systems, Horten , Norway, version 10.0 ) . The images will be analyzed in the longitudinal sections ( 4 bedrooms , 3 bedrooms and 2 cameras) . The endocardium is drawn manually from the septum to the lateral mitral annulus. A region of interest will be applied automatically by the software.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary Test
Time Frame: 1 day
Cardiopulmonary exercise testing will be carried out by the treadmill ramp method ( Centurium 300 , Micromed , Brazil ) through ErgoPC Elite® software associated with the electrocardiogram ( Micromed , Brazil ) with 12 channels. Respiratory variables will be evaluated by a gas analyzer ( Cortex - Metalyzer II , Germany) being obtained in standard conditions of temperature , pressure and humidity ( STPD ) , breath - by - breath , with the patient breathing in a face mask without leaks during exercise. Will be assessed during the test , functional capacity , measured in METs , VO2 , VE / VCO 2 , VE / VCO 2 slope , T1 / 2VO2 and RFC1 .
1 day

Collaborators and Investigators

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

Sponsor

Daniella Cunha Brandao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

August 6, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rafael_cardio

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.

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