NCT07420907招募中不适用
A Non-interventional Observational Study of the Sustained Use of Prolaio Digital Health Devices to Monitor the Natural History of Chronic Cardiovascular Conditions in Ambulatory Patients
Prolaio1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2025年10月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Longitudinal Assessment of Clinical Status
研究概览
简要总结
This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •18 years of age and older
- •Ability to understand study assessments and give informed consent to data collection
- •Ability to comply with the study protocol
- •Ability to understand and respond to instructions in English
- •Has diagnosis of qualifying Cardiovascular Disease(s), including but not limited to: HF, AS, HCM, HTN, DCM, etc. Additional CVD may be included at discretion of the investigators.
- •Resides in the United States
排除标准
- •Allergy to adhesive used in biosensor patch
- •Life-threatening disease process outside of area under study, such as actively treated cancer or being actively considered for organ pre-transplant (such as hepatic failure; end-stage renal disease).
- •Severe CVD defined by hospital admission for cardiac diagnosis within 30 days of enrollment or documentation of NYHA functional class IV
- •-- For participants who do not qualify due to this exclusion, and have not been hospitalized within 30 days of enrollment, they may reapply to enroll in the study
- •Self-reported weight of 400 pounds or greater
研究组 & 干预措施
Cardiovascular Disease (CVD)
Participants who have been diagnosed including but not limited to the following Cardiovascular Disease types: Aortic Stenosis, Heart Failure, Hypertension Obstructive Cardiomyopathy, Dilated Cardiomyopathy
结局指标
主要结局
Longitudinal Assessment of Clinical Status
时间窗: Baseline through each 90-day cycle
Measured by Heart Rate (beats per minute)
次要结局
未报告次要终点
研究者
研究点 (1)
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