NCT02869178

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

August 6, 2016

Last Update Submit

August 11, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Echocardiography for obtaining the "strain "

    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 Outcomes (1)

  • Cardiopulmonary Test

    1 day

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernmabuco

Recife, Pernambuco, Brazil

RECRUITING

Related Publications (3)

  • Becker M, Hoffmann R, Kuhl HP, Grawe H, Katoh M, Kramann R, Bucker A, Hanrath P, Heussen N. Analysis of myocardial deformation based on ultrasonic pixel tracking to determine transmurality in chronic myocardial infarction. Eur Heart J. 2006 Nov;27(21):2560-6. doi: 10.1093/eurheartj/ehl288. Epub 2006 Oct 11.

    PMID: 17035253RESULT

  • Belohlavek M, Pislaru C, Bae RY, Greenleaf JF, Seward JB. Real-time strain rate echocardiographic imaging: temporal and spatial analysis of postsystolic compression in acutely ischemic myocardium. J Am Soc Echocardiogr. 2001 May;14(5):360-9. doi: 10.1067/mje.2001.110786.

    PMID: 11337681RESULT

  • Chan J, Hanekom L, Wong C, Leano R, Cho GY, Marwick TH. Differentiation of subendocardial and transmural infarction using two-dimensional strain rate imaging to assess short-axis and long-axis myocardial function. J Am Coll Cardiol. 2006 Nov 21;48(10):2026-33. doi: 10.1016/j.jacc.2006.07.050. Epub 2006 Oct 31.

    PMID: 17112992RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Daniella C Brandão, pHD

CONTACT

+558121268000daniellacunha@hotmail.com

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 6, 2016

First Posted

August 16, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2016

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

BR(1)