Developing a Non-invasive Cardiac Functional Health Status Measurement Device to be Used in a Critical Population of Adults and Children With Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Pulse Rate
研究概览
简要总结
This is a single-center, non-randomized study.Enrolled patients will be placed on a tilt table and a stress test will be performed in a total of 4 different positions. Their blood pressure will be measured at each position. Also, a pulse oximeter will be placed on the forehead to measure pulse rate and strength. These results will be compared to cardiac functional classifications defined by New York Heart Association (NYHA) criteria for adults and New York Pediatric Heart Failure (NYPHF) index for our pediatric age patients. The primary aim of this initiative is to assess the discriminatory value of a cardiac functional health classification based upon the degree of dependency of cardiac function on changes in cardiac preload and afterload circulatory volume.
详细描述
Participants will be asked to review the informed consent and consent to the study prior to any study procedures. The study will consist of a single visit to the Medical Plaza at the University of Florida. During this visit, Enrolled patients will be placed on a tilt table and their position changed to a total of 4 different positions. Their blood pressure will be measured at each position. Also, a pulse oximeter will be placed on the forehead to measure pulse rate and strength. The study will take approximately 25 minutes. Data collected shall include a questionnaire for the patient, a list of the patient's co-morbidities, an echocardiogram or catheter lab data if available, and a list of the patient's current medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Heart failure patient eligibility shall consist of the following:
- •Group 1a: 5 adult heart transplant patients
- •Age ≥ 21 years old and <74 years old
- •Speaks and understands English
- •Provides Informed Consent
- •Group 1b: 5 pediatric heart transplant patients
- •Age ≥ 7 years old and < 21 years old
- •Speaks and understands English
- •Provides Informed Consent
- •Group 2: 5 adult heart failure patients
- •Age ≥ 21 years old and <74 years old
- •Speaks and understands English
- •Provides Informed Consent
- •Group 3: 5 adult aged Fontan patients
- •Age ≥ 21 years old and <74 years old
- •Speaks and understands English
- •Provides Informed Consent
- •Group 4: 5 pediatric Fontan patients
- •Age ≥ 7 years old and < 21 years old
- •Speaks and understands English
- •Provides Informed Consent
- •Group 5: 5 pediatric patients limited to heart murmurs
- •Age ≥ 7 years old and < 21 years old
- •Speaks and understands English
- •Provides Informed Consent
- •Group 6: 5 normal adult patients
- •Age ≥ 21 years old and <74 years old
- •Speaks and understands English
- •Provides Informed Consent
排除标准
- •• Unstable patients per judgment of the clinician prior to the start of the treatment
- •Patients unable to have blood pressure cuff measured on the upper arm
- •Inability to wear monitor on forehead
- •Patients will be excluded from the study if they have eaten, consume caffeinated beverages, or taken hypertensive medications within 2 hours of testing
结局指标
主要结局
Pulse Rate
时间窗: Average pulse rate from baseline to 30 minutes
Continuous change of pulse rate from baseline through the end of the study will be followed. Changes in pulse rate will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. From the graph, average pulse rate is calculated.
Pulse Strength
时间窗: Average pulse strength from baseline to 30 minutes
Continuous change of pulse strength from baseline through the end of the study. Pulse strength is measured as volts by the system. Changes in pulse strength will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. Cardiac function curves will be constructed with the data collected and average pulse strength from baseline to 30 minutes will be reported.
次要结局
未报告次要终点