NCT04149743招募中不适用
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure [HATS-OFF]
Aventusoft, LLC.2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2022年1月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- The number of recurrent HF readmissions. [Monitoring period: 30 days]
研究概览
简要总结
Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.
详细描述
The overall objective of research is to test, adapt, refine and validate the HEMOTAG® system to be used outside the usual medical care environments to reduce hospital readmissions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 22 years old.
- •An index hospital admission for ADHF presenting with symptoms, clinical signs, and chest x-ray (CXR) findings of pulmonary congestion, receiving IV diuretics or vasoactive drugs and having a BNP > 350 or NT-pro BNP > 1800 pg/ml.
- •Able to give informed consent.
- •Participant's residence has adequate cellular data coverage.
- •Participants with previous diagnosis of left ventricular ejection fraction (LVEF) <40% prior to the index hospitalization must have been treated for at least 90 days prior to enrollment with diuretics and beta-blocker (unless intolerant or contraindicated) and an ACE inhibitor or ARB or ARNi (unless intolerant or contraindicated).
排除标准
- •Participants unable to provide informed, voluntary decision to participate in research study as determined by the investigator. (Exclude participants who necessitate the involvement of a legally authorized representative.)
- •Terminal condition with life expectancy less than 6 months as determined by investigator.
- •Participants with cardiac tamponade or constrictive pericarditis.
- •Participants with left ventricular assistance device (LVAD device) or had a cardiac transplantation or listed for transplantation.
- •Implantation of a CRT (cardiac resynchronization therapy) device during index hospitalization or intent to implant a CRT device.
- •Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation, as determined by investigator.
- •Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis, as determined by investigator.
- •Severe primary pulmonary, renal or hepatic disease, as determined by investigator.
- •Women of childbearing age (Age <50).
- •History of pulmonary embolism of less than 3 months.
- •Dialysis dependent or dialysis initiation expected within three months.
- •Chronic home IV therapy or cardiac inotropes or diuretics.
- •Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment.
- •Illness/ Condition which may be aggravated or cause significant discomfort by the application of the HEMOTAG (skin issues, e.g. Intolerance to use of skin electrodes).
- •Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator's assessment.
- •Congenital heart malformations (Complex, or uncorrected congenital heart disease).
- •Participant enrolled in another interventional study (observational or registries are not excluded).
- •Participant HF is managed remotely with another monitoring device or program (for example: Pulmonary/ Lt Atrial pressure monitoring, lung fluid monitoring. BNP/pro-BNP or bioimpedance or ICD or biventricular pacemaker with impedance monitoring will be allowed unless it is part of another research protocol).
- •Prisoners and wards of the state.
- •Inability to provide informed consent (Must speak English or Spanish or Creole).
研究组 & 干预措施
Randomized Standard of Care
No Intervention
Standard of Care
Randomized Standard of Care with HEMOTAG
Active Comparator
Standard of Care with HEMOTAG
干预措施: Standard of Care with Hemotag (Diagnostic Test)
结局指标
主要结局
The number of recurrent HF readmissions. [Monitoring period: 30 days]
时间窗: 30 Days
Determine if HEMOTAG can reduce the relative number of HF readmissions or ER visits versus standard of care. \[Monitoring period: 30 days from time of participant's discharge from initial index hospitalization\]
次要结局
- Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months](6 Months)
- Skin irritation from HEMOTAG use [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use.)(30 Days)
- Time from discharge until the first event of HF readmissions [Monitoring period: Event time assessed up to 3 months and 6 months from discharge.(6 Months)
- Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months](6 Months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal SurgeryHypotension During SurgeryNCT06439732Fondazione Policlinico Universitario Agostino Gemelli IRCCS84
撤回
不适用
Hexoskin Feasibility Study With COVID-19 PatientsCOVID-19NCT04453891Nguyen Thu Ngan Trinh
尚未招募
不适用
Evaluation of less invasive hemodynamic monitoring in optimizing preoperative management of PIH patients undergoing cesarean sectiopregnancy induced hypertensionJPRN-UMIN000012311Saitama Medical Center20
暂停
3 期
A Study to Evaluate the Impact of Maintaining Hemoglobin Levels in Anemic Patients With Carcinoma of the CervixCervical CancerAnemiaNCT00921635Tri-Service General Hospital2
已完成
不适用
Simple Initiation of Advanced Hybrid Closed Loop SystemDiabetes type1NCT05069727Sidra Medicine34