ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early Prevention in the GREAT LakEs Region Project 4: Portable Air Cleaners to Treat Heart Failure and Negate Disparities of Environment and Race (PATHFINDER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- The impact of PAC use for 90 days after hospital discharge for HF compared to sham on NTproBNP level.
研究概览
简要总结
ACHIEVE-P4: PATHFINDER is a randomized, blinded clinical trial of portable air cleaners (PAC) provided at the time of hospital discharge to Heart Failure (HF) patients. It will be carried out at Henry Ford Hospitals. This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A). The ACHIEVE GREATER Center involves several separate but related projects that aim to prolong lifespan among Detroit, MI and Cleveland, OH, for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Projects 2 & 4) and coronary heart disease (CHD, Project 3). The present study is Project 4 (Aim 1) a randomized clinical trial titled: Portable Air cleaners to Treat Heart Failure and Negate Disparities of Environment and Race (PATHFINDER), of the ACHIEVE GREATER Center.
Project 4 is a randomized, double-blind, parallel limb trial of 400 patients with hospitalized HF who will be provided active PAC vs sham at discharge from HFH.
Participants will receive two PACs at discharge and an indoor PM2.5 sensor. PACs will be randomized to either active PAC with HEPA filters or sham PAC without HEPA filters.
Researchers will compare the following outcomes of the two groups (more outcomes below in Outcome Measures section):
- Change in NTproBNP from baseline to 90 days
- Home PM2.5 levels from baseline to 90 days
- Clinical events such as death and hospitalization will be monitored
详细描述
Project 4 of ACHIEVE GREATER aims to improve outcomes for symptomatic (Stage C) HF. This is vitally important because HF is the most common final manifestation of cardiometabolic diseases in the U.S., accounting for nearly 400,000 deaths and 900,000 hospitalizations per year. Growing evidence implicates air pollutants adversely impact HF and its prognosis. For example, among 12,474 HF patients in North Carolina, hospital readmission rates at 90-days were increased by 13-14% for every 1 μg/m3 elevation in fine particulate matter <2.5 µm air pollution (PM2.5) levels. While average U.S. air quality has improved, urban communities continue to have higher levels of exposure. Indeed, Detroit residents face the highest PM2.5 concentrations in Michigan (97th percentile for the U.S.). We hypothesize that this may contribute to worse outcomes among HF patients in Detroit, including an unacceptably high rate of death or rehospitalization (22% based on Henry Ford Health [HFH] data for 2022) at 90-days post-discharge. To combat this problem, we propose to test an emerging therapeutic intervention, the portable air cleaner (PAC), that we hypothesize will reduce personal-level exposure to PM2.5 resulting in improved clinical outcomes for HF patients. This novel intervention is both practical and scalable, and thus has the potential to revolutionize the treatment of HF and improve related outcomes nationwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigators will use mixed block sizes (2, 4, 6) for randomizing participants. Control versus PAC interventional units will be prepared by study staff who will not directly enroll patients. The crosswalk for patient study ID and randomization status will be kept in a secure separate location so that PI and staff in charge of data analysis will not be aware of randomization status.
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
- •Currently in the emergency room or hospitalized with plan to be discharged to home, or
- •Diagnosis of heart failure
- •BNP>200 ng/L or NTproBNP>1000 ng/L during hospitalization or within 1 month prior to screening
- •Expected ability to fully participate in study (can tolerate study processes, no long travel)
排除标准
- •Hemodialysis dependent
- •If dialysis is being considered by participant's care team and their eGFR value is <30 mL/min/1.73 sq m
- •Life expectancy of less than one year
- •Inability to provide written informed consent
- •Age less than 18 years old
- •Patients with a left ventricular assist device (LVAD)
- •Heart transplant recipients
- •Individuals who regularly use a HEPA air cleaner in their home at screening
- •Current smokers of nicotine or marijuana
- •Severe aortic or mitral valve disease
- •Has a scheduled, non-diagnostic cardiac procedure within 30 days prior, or in the next 90 days from screening (e.g. PCI, resynchronization, any cardiac surgery)
- •If the PI decides for any reason that participation in the trial is not in the best interest of the patient
研究组 & 干预措施
PAC Intervention Arm
Participants randomized to the interventional arm will be given 2 PAC units with HEPA filters inside to be used in the home: one in the room patient sleeps in, the other in the living area of the home. Participants will also be given an air quality monitor. Study staff will educate the patient on use of the filters and monitor.
Patients will be seen in clinic for 30-day and 90-day follow-up visits. Blood pressure, blood draw for biomarker levels, 6-minute walk distance, and questionnaires will be completed.
Patients will be allowed to keep the PAC at the end of the trial and will be informed at that time how to purchase additional filters.
干预措施: PAC provision at hospital discharge (Other)
Control non-interventional Arm
Participants randomized to the non-interventional arm will be given 2 PAC units without HEPA filters inside to be used in the home: one in the room patient sleeps in, the other in the living area of the home. Participants will also be given an air quality monitor. Study staff will educate the patient on use of the filters and monitor.
Patients will be seen in clinic for 30-day and 90-day follow-up visits. Blood pressure, blood draw for biomarker levels, 6-minute walk distance, and questionnaires will be completed.
Patients will be allowed to keep the PAC at the end of the trial and will be informed at that time how to purchase additional filters.
干预措施: Control non-intervention; PAC without filter (Other)
结局指标
主要结局
The impact of PAC use for 90 days after hospital discharge for HF compared to sham on NTproBNP level.
时间窗: Baseline at hospital discharge to 90 days.
Change in NTproBNP from baseline to 90 days. This will be determined by comparing the NTproBNP value at the 90-day follow up visit versus the baseline NTproBNP value measured from blood draw at enrollment/randomization visit (within 48 hours of hospital discharge).
次要结局
- The effect of PAC use on clinical events (death) in the active PAC group versus sham group(Baseline to 90 days)
- The effect of PAC use on home PM2.5 levels in active PAC group versus sham group(Baseline to 90 days)
- The effect of PAC use on clinical events (hospitalization) in the active PAC group versus sham group(Baseline to 90 days)
研究者
David Lanfear
Senior Staff Physician
Henry Ford Health System