Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Preventative Care of Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- associations between alteration of HD values to hospital admission
研究概览
简要总结
Study Details
What is the study design? (eg, randomized, double-blind) Observational Prospective Study
What are the overall objectives of the study? This project is designed to assess the feasibility of using a non-invasive hemodynamic monitoring device in heart failure outpatient clinics. There will be no alteration to patient management for this study. Rather this study seeks to assess the utility of the device by evaluating for the parameters obtained from the device to hospital admission.
How your research will contribute to the advancement of scientific knowledge?
☒This study will confirm/strengthen existing knowledge. ☒This study will test a completely novel hypothesis. ☒This study will explore novel endpoints. ☐Other [please describe]:
详细描述
B. BACKGROUND:
Nearly five million Americans experience heart failure (HF) and greater than 250,000 die annually. 1 The prevalence has continued to increase with the aging of the US population and HF is now the leading cause of hospitalization among adults >65 in the United states. Despite remarkable improvements in medical therapy, the prognosis of patients with myocardial failure remains poor, with almost 20% of patients dying within 1 year of initial diagnosis and > 80% 8-year mortality. 2 In addition patients who are admitted to the hospital for heart failure have over a 50% readmission rate within six months of discharge. 3,4 These patients require routine clinical care and often require diagnostic and therapeutic procedures. This project seeks to assess if the use of hemodynamic (HD) monitoring technologies (ClearSight/Nexfin) that are currently used in the intraoperative and critical care settings can provide utility by demonstrating associations between alterations in a patients HD values to the likelihood of hospital admission.
The non-invasive HD device utilized (Nexfin, Edwards Lifesciences, Irvine, CA) provided flow-guided cardiovascular parameters that were captured for each clinic visit for up to 24 months. Analysis was performed between the most recent prior clinic visits for patients who were hospitalized for HF exacerbation to those who were not hospitalized. HD data was not used to guide clinical care. A Cox hazard model using a log transformation of HD variables as the covariates, was applied to describe hospital admission.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients seen in Loma Linda heart failure clinics classified as New York Heart Association (NYHA) Functional Classification of 3 or greater.
排除标准
- •Age < 18 years of age,
- •pregnancy,
- •known severe peripheral artery disease,
- •poor perfusion to fingers (as defined as a perfusion index less than 0.5%- www.Masimo.com),
- •history of Raynaud's,
- •refusal to provide written consent.
结局指标
主要结局
associations between alteration of HD values to hospital admission
时间窗: 24 months
次要结局
未报告次要终点
研究者
Davinder Ramsingh, MD
Study Principal Investigator
Loma Linda University
