Assessment of Functional Capacity and Inflammatory Markers in Women With Heart Failure With Preserved Ejection Fraction
- Conditions
- Heart Failure, DiastolicInflammationCoronary Artery Disease
- Registration Number
- NCT02649400
- Lead Sponsor
- Federal University of São Paulo
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.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 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
Name Time Method 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.
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
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
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
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)
Trial Locations
- Locations (1)
Federal University of Sao Paulo
🇧🇷Sao Paulo, Brazil