Strain X Cardiopulmonary Test

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02869178
• Other study ID #: Rafael_cardio
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2016
• Last updated: August 11, 2016
• Start date: August 2016

Study information

• Verified date: August 2016
• Source: Universidade Federal de Pernambuco
• Contact: Daniella C Brandão, pHD
• Phone: +558121268000
• Email: daniellacunha[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernmabuco	Recife	PE

Sponsors (1)

Lead Sponsor	Collaborator
Daniella Cunha Brandao

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Becker M, Hoffmann R, Kühl HP, Grawe H, Katoh M, Kramann R, Bücker 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):256 — View Citation

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. — View Citation

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):202 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Cardiopulmonary Test	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	Yes