Assessment of Functional Capacity and Inflammatory Markers in Women With Heart Failure With Preserved Ejection Fraction

NCT ID: NCT02649400

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31

Brief Summary

This study assesses the impact of diastolic heart failure on exercise capacity in women who have a previous coronary condition. All the participants will go through the same evaluation.

Detailed Description

It is well established that systolic heart failure impacts exercise capacity and quality of life, diastolic heart failure however, is not well documented as a condition that reduces physical performance.

To confirm that patients have a diastolic disfunction an echocardiography will be performed, this will also yield the left ventricle ejection fraction to confirm the preserved ejection fraction heart failure diagnostics.

Exercise capacity will be assessed using the distance walked on the six-minute walking test, performed on a 30m corridor.

Pulmonary function will be assessed with spirometry and values of forced vital capacity and forced expired volume in one second will be recorded and compared to the age-predicted values.

Respiratory strength will be determined by maximal pressure achieved on a respiratory manometer.

Peripheral muscular strength will be assessed with a handheld dynamometer. Knee extension strength of the dominant leg will be recorded.

An echocardiography will be performed to assess systolic and diastolic function and ejection fraction.

Heart autonomic function will be evaluated using a heart rate monitor and a computer software to identify the sympathovagal balance.

Conditions

Heart Failure, Diastolic; Coronary Artery Disease; Inflammation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Diastolic Heart Failure

Women with diastolic heart failure and previous coronary artery disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Women;
• Aged between 35 and 70 years;
• Coronary artery disease proven by coronary angiography;
• Diastolic heart failure confirmed by recent echocardiography (6 months);
• Left Ventricle ejection fraction of greater than 50%;
• Absence of acute or chronic pulmonary disease;
• Patient clinically compensated;
• Consent form signed for participation in the research

Exclusion Criteria

• Inability to perform spirometry;
• Presence of acute or chronic pulmonary disease;
• Chronic inflammatory disease, kidney or liver disease;
• Patients using corticosteroids, aspirin or other nonsteroidal anti-inflammatory;
• Clinical or laboratory evidence of infection;
• Morbid obesity;
• Hemodynamic instability at the time of spirometry;
• Patient's or legal guardian request to leave at any time of the study.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Daniel Figueiredo Alves da Silva

Post-graduate Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Figueiredo Alves da Silva, PT

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

15218913.6.0000.5505

Identifier Type: -

Identifier Source: org_study_id