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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT02649400

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Diastolic Coronary Artery Disease Inflammation

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.

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Assessment of Functional Capacity, Inflammatory Markers and Autonomic Function in Women With Heart Failure With Preserved Ejection Fraction and Previous Coronary Artery Disease

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Diastolic Heart Failure Women with diastolic heart failure and previous coronary artery disease

Outcome Measures

Primary Outcome Measures

Functional Capacity [Up to 1 year after diagnosis]
Measured by the distance walked in the six-minute walking test in meters.
Inflammatory markers [Up to 1 year after diagnosis on the same day as functional capacity assessment]
Inflammatory markers evaluated using specific assays for blood analysis Interleukin (IL) 1 (pg/mL), IL-6 (pg/mL), IL 8 (pg/mL),Tumor Necrosis Factor alpha (pg/mL), Brain Natriuretic Peptide (BNP) (pg/mL), pro-BNP (pg/mL); Lab results will be analysed for each marker and values will be compared to laboratory reference data to identify values out of range.
Inflammatory Markers [Up to 1 year after diagnosis on the same day as functional capacity assessment]
Inflammatory markers evaluated using specific assays for blood analysis for high sensitivity C reactive protein (mg/L), alpha-1-acid glycoprotein (mg/dL) and platelets (platelets/cubic millimeters), lactate (mg/dL), uric acid (mg/dL)

Secondary Outcome Measures

Heart autonomic function [Up to 1 year after diagnosis on the same day as functional capacity assessment]
Sympathovagal balance assessed by heart rate variability using a heart monitor
Quality of life [Up to 1 year after diagnosis on the same day as functional capacity assessment]
Quality of life assessed by the Minnesota questionnaire specific for heart failure
Pulmonary function [Up to 1 year after diagnosis on the same day as functional capacity assessment]
Pulmonary function assessed by spirometry for obtaining values of forced expired volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio
Respiratory muscle strength [Up to 1 year after diagnosis on the same day as functional capacity assessment]
Respiratory muscle strength assessed by manometer for obtaining maximal inspiratory pressure and maximal expiratory pressure values in cmH2O.
Peripheral muscle strength [Up to 1 year after diagnosis on the same day as functional capacity assessment]
Peripheral muscle strength assessed by the quadriceps strength using a portable dynamometer in kilogram-force (kgf)

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.