Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure: a Prospective Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Endothelial Function
研究概览
简要总结
Exposure to air pollution is associated with increase in cardiovascular morbidity and mortality. Controlled human exposure studies have demonstrated impaired vascular function and heart rate variability on healthy volunteers. The aim of this study is to investigate the effects of reducting diesel exhaust inhalation on endothelial function, heart rate variability and cardiopulmonary stress testing in healthy volunteers and patients with chronic heart failure, by using a filter mask.
详细描述
Design and setting: Double-blind randomised crossover studies in a university teaching hospital
Patients: 30 patients with stable Heart Failure (NYHA I-III) and 15 healthy volunteers
Interventions: All 45 subjects will be exposed to dilute diesel exhaust (PM2.5 of 300 mg/m3), filtered diesel exhaust (filter mask), or filtered air
Main outcome measures: Endothelial function, heart rate variability, six-minute walking test and blood samples for inflammatory factors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •NYHA I-III;
- •Left Ventricle Ejection Fraction < 50%;
- •Clinical condition stable for more than three months prior to the randomization;
排除标准
- •Severe arterial hypertension;
- •Severe Pulmonary disease;
- •Patients with pace-markers;
- •Patients with constrictive pericarditis;
- •Severe chronic kidney disease;
- •Patients with pulmonary hypertension;
- •Stroke within the last six months;
- •Severe hepatic disease;
- •Patients with musculoskeletal limitations to exercise;
- •Patients with cardiac cachexia.
结局指标
主要结局
Endothelial Function
时间窗: six months
Endothelial function assessment is based on an endothelially mediated arterial response at the distal phalanx of a finger, in response to a five-minute occlusion of the brachial artery. Arterial stiffness is assessed by a finger plethysmographic probe.
次要结局
- Six-minute walking test(Six months)
- Heart rate variability(six months)
- Inflammatory Markers(12 months)
研究者
Jefferson Luis Vieira
MD
InCor Heart Institute