Noninvasive Home Assessment of Cardiac Filling Pressure to Identify Heart Failure Patients at High Risk for Readmission
试验速览
- 阶段
- 不适用
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Association between change in estimated LVEDP and the occurrence of heart failure events.
研究概览
简要总结
Patients who are admitted with acutely decompensated heart failure and are receiving intravenous diuretics will be recruited to undergo testing using the Indicor Device. Participants will be tested daily while hospitalized and then on the day of discharge during which time they will be trained how to operate the device. Once discharged, patients will perform one test in the morning, and one test in the evening for up to 30 days.
详细描述
The study will follow the design of a prospective observational cohort study. Patients who are admitted with acutely decompensated heart failure and are receiving intravenous diuretics will be recruited to undergo testing with the Indicor Device for estimating left ventricular end diastolic pressure (LVEDP). Trends in estimated LVEDP will be assessed after thirty days at home to identify trends that coincided with heart failure events.
The Indicor is a noninvasive device that assesses cardiac filling pressure based on the long understood phenomenon that performing a Valsalva maneuver induces changes in pulse pressure that reflect cardiac filling pressure.Testing with the Indicor consists of blowing into the device while performing a Valsalva Maneuver for 10 seconds, and the index finger will be placed inside a PPG sensor during the test. Each test consists of three recorded efforts with 45 seconds rest between efforts.
Participants will be tested daily while hospitalized and then on the day of discharge during which time they will be trained how to operate the device. In order to proceed with home use, they will need to demonstrate the ability to properly operate the device and complete testing without assistance. Demographic and clinical data will also be collected including laboratories, comorbidities, and heart failure etiology. Once a subject demonstrates proper operation an Indicor will be provided to them for use at home for the study duration. Once the subjects are home, they will be asked to perform the test each morning and each evening.
In the AM, subjects will be asked to weigh themselves upon awakening after using the restroom, and will be asked to perform the device test afterward. Subjects will be asked six simple, standardized symptom-related questions:
- Have you felt more short of breath during the last day?
- Have you noticed more swelling in the last day?
- Did you wake up short of breath last night?
- Did you sleep in a chair, or prop up with pillows more than usual last night?
- Have you had any lightheadedness or dizziness in the last day?
- Enter morning weight.
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
- •Admitted to Johns Hopkins Hospital, or Johns Hopkins Bayview Medical Center with acutely decompensated heart failure (HFrEF or HFpEF)
- •Requires IV diuresis
排除标准
- •Acute coronary syndrome (type 1 myocardial infarction)
- •Terminal non-cardiac illness (that can affect short term prognosis)
- •Operative cardiac procedure during admission (bypass, valve, transplant, LVAD)
- •End-stage renal disease on dialysis
- •Pregnant women (as verbally indicated by patients being approached for recruitment, or through clinically indicated pregnancy tests ordered by the patient's clinicians)
- •History of paradoxical emboli
- •Hypertrophic obstructive cardiomyopathy
- •Known intracardiac shunt
- •Known severe aortic valve stenosis
- •Known severe mitral valve stenosis
- •Myocardial infarction within one week of intended Indicor testing
- •Uncontrolled hypertension (systolic BP >160mmHg or diastolic BP> 100mmHg)
- •Hypotension (systolic BP <90mmHg)
- •Symptomatic bradycardia
- •Known cholesterol emboli
- •Poor left ventricular function with left ventricular thrombus
- •Unstable angina
结局指标
主要结局
Association between change in estimated LVEDP and the occurrence of heart failure events.
时间窗: 30 days post discharge
Twice daily, non-invasive measures to estimate LVEDP (mmHg) will be retrospectively assessed to determine if changes or trends in estimated LVEDP were associated with, and therefore predictive of, 30-day readmission, mortality or need for intravenous diuretics in heart failure patients.
次要结局
未报告次要终点