Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 3
- 主要终点
- Change in Distance Walked
研究概览
简要总结
Indoor air pollution and fine mode particulate matter with an aerodynamic diameter smaller than 2.5 micrometers (PM2.5) is a major contributor to global morbidity and mortality, particularly due to cardiovascular disease. This project aims to demonstrate the efficacy, feasibility and effectiveness of portable air filters in improving indoor PM2.5 levels and improving functional capacity of heart failure patients with reduced ejection fraction in India. The findings from the project will add to existing knowledge of innovative and scalable strategies to improve environmental and cardiovascular health worldwide.
The overall objective of this study is to demonstrate the efficacy, feasibility, and effectiveness of portable air filters in improving indoor PM2.5 levels and improving functional capacity of heart failure patients with reduced ejection fraction in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years of age diagnosed with HF with a reduced ejection fraction of ≤ 40% within the last six months in NYHA class II-IV.
排除标准
- •listed for a cardiac transplant
- •history of CRT device implantation in last 3 months
- •on oxygen therapy
- •with severe pulmonary disease
- •participants unable to ambulate
研究组 & 干预措施
HEPA Air Purifier
Air purifier is installed in participants' households by the research team. Twice per year, participants will wear a GPS as well as a backpack containing a particulate matter 2.5 (PM2.5) personal exposure monitor for a 24-hour monitoring period.
干预措施: AirOk Air Purifier (Other)
EGAPA Air Purifier
Air purifier is installed in participants' households by the research team. Twice per year, participants will wear a GPS as well as a backpack containing a particulate matter 2.5 (PM2.5) personal exposure monitor for a 24-hour monitoring period.
干预措施: Placebo Air Filter (Other)
结局指标
主要结局
Change in Distance Walked
时间窗: Baseline, 12 months
The distance in meters will be recorded during a 6-minute walk test (MWT)
次要结局
- Change in pro B-type natriuretic peptide (Pro-BNP) Levels(Baseline, 12 months)
- Change in Systolic Blood Pressure (SBP)(Baseline, 12 months)
- Change in Diastolic Blood Pressure (DBP)(Baseline, 12 months)
- Change in Number of Hospitalizations(Baseline, 12 months)
- Change in Heart Rate(Baseline, 12 months)