Gas Exchange for Predicting Hospital Heart Failure Readmissions Clinical Evaluation Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- 1. To evaluate if exercise gas exchange tests can predict 30 day hospital readmission for heart failure.
研究概览
简要总结
To determine whether, and if so, which gas exchange parameters measured on the Shape-HF Cardiopulmonary Exercise Testing System predict 30 and 180 day re-hospitalization in subjects discharged from hospitalization for an episode of acute decompensated heart failure.
详细描述
This is a prospective, single-specialty clinical study. This study is intended to evaluate the select gas exchange parameters during a short, sub-max bout of exercise using a simple stationary step on day of discharge to predict the subjects' readmission for acute decompensated heart failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject is 18 Years and older
- •Subject is hospitalized for acute decompensated heart failure (ADHF)
- •Systolic OR
- •Subject is Stage C:Class II/III/IV heart failure
- •Subject is willing and to provide appropriate informed consent
- •Subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule
- •Subject is willing to use the Shape-HF Cardiopulmonary Exercise Testing System
排除标准
- •The subject is pregnant (verified in a manner consistent with institution's standard of care)
- •Subject is currently participating in another investigational device or drug trial
- •Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition
- •Subject is unwilling or unable to return for the required follow-up after test
- •Subject has Left Ventricular Assist Device (LVAD)
- •Subject is listed for transplant
- •Subject has a clinical diagnosis of acute myocardial infarction (AMI) on admission (Note: If troponin measurements have been collected and are elevated but not due to an MI subject is still eligible for study)
- •Subject has a pulmonary embolism (PE) on admission
- •Subject is dialysis dependent
- •Subject has a cardiac resynchronization device (CRT) which has been re-programmed at any time during the study
- •Subject has Chronic Obstructive Pulmonary Disease (COPD) who is oxygen or steroid dependent
- •Subject has severe hypertension > 180 millimeter of mercury (mmHg) resting systolic at time of test
- •Subject has severe heart failure with renal insufficiency (with Creatinine clearance rate (CrCL) of 30 or less) and/or on IV Inotropic therapy and/or enrolling in hospice
结局指标
主要结局
1. To evaluate if exercise gas exchange tests can predict 30 day hospital readmission for heart failure.
时间窗: 30 days ± 3 days post discharge
The analysis of exercise gas exchange (using the Shape-HF Cardiopulmonary Exercise Testing System) of the incidence of hospital readmission through 30 days ± 3 days post discharge follow-up.
2. To evaluate which gas exchange patterns were most highly associated with 30 day risk of readmission for recurrent acute decompensated heart failure.
时间窗: 30 days ± 3 days post discharge
The analysis of exercise gas exchange (using the Shape-HF Cardiopulmonary Exercise Testing System) of the incidence of hospital readmission through 30 days ± 3 days post discharge follow-up.
3. To determine the incidence of Adverse Events (AE) and Serious Adverse Events (SAE).
时间窗: 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge
The analysis of the incidence of AEs and SAEs on the day of discharge post Shape-HF Cardiopulmonary Exercise Testing System through 30 days ± 3 days post discharge follow-up and through 180 days ± 15 days post discharge follow-up.
次要结局
- 1. To evaluate if exercise gas exchange tests can predict 180 day hospital readmission for heart failure.(180 days ± 15 days post discharge)
- 2. To evaluate which gas exchange patterns were most highly associated with 180 day risk of readmission for recurrent acute decompensated heart failure.(180 days ± 15 days post discharge)