Coronary Artery Disease, Heart Failure, Diastolic, Inflammation
Conditions
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.
Interventions
None listed
Sponsors
Federal University of São Paulo
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
Countries
Brazil
Outcome results
None listed