Assessment of Functional Capacity, Inflammatory Markers and Autonomic Function in Women With Heart Failure With Preserved Ejection Fraction and Previous Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Inflammatory markers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Inflammatory markers
时间窗: 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
时间窗: Up to 1 year after diagnosis
Measured by the distance walked in the six-minute walking test in meters.
Inflammatory Markers
时间窗: 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)
次要结局
- Respiratory muscle strength(Up to 1 year after diagnosis on the same day as functional capacity assessment)
- Heart autonomic function(Up to 1 year after diagnosis on the same day as functional capacity assessment)
- Pulmonary function(Up to 1 year after diagnosis on the same day as functional capacity assessment)
- Quality of life(Up to 1 year after diagnosis on the same day as functional capacity assessment)
- Peripheral muscle strength(Up to 1 year after diagnosis on the same day as functional capacity assessment)
研究者
Daniel Figueiredo Alves da Silva
Post-graduate Student
Federal University of São Paulo