An observational study in Heart Failure, Diastolic, Coronary Artery Disease and Inflammation, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-01-12.
Sponsored by Federal University of São Paulo · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 50 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women with coronary artery disease diagnosed through angiography and heart failure with preserved ejection fraction diagnosed via ecocardiography.
Exclusion Criteria:
Women with diastolic heart failure and previous coronary artery disease
Functional Capacity
Measured by the distance walked in the six-minute walking test in meters.
Time frame: Up to 1 year after diagnosis
Inflammatory markers
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.
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Inflammatory Markers
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)
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Heart autonomic function
Sympathovagal balance assessed by heart rate variability using a heart monitor
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Quality of life
Quality of life assessed by the Minnesota questionnaire specific for heart failure
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Pulmonary function
Pulmonary function assessed by spirometry for obtaining values of forced expired volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Respiratory muscle strength
Respiratory muscle strength assessed by manometer for obtaining maximal inspiratory pressure and maximal expiratory pressure values in cmH2O.
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Peripheral muscle strength
Peripheral muscle strength assessed by the quadriceps strength using a portable dynamometer in kilogram-force (kgf)
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Plan to share: No
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This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo