Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Surrogate marker of hemodynamic responses to therapy.
研究概览
简要总结
The primary purpose of this study is to learn if taking pictures of your heart using two dimensional and three dimensional echocardiography in the heart failure intensive care unit can be helpful to understanding how the heart is working.
All research subjects will be adults admitted to the heart failure ICU with acute decompensated heart failure and requiring monitoring of their heart function using a catheter that is placed in the pulmonary artery which is a blood vessel. In this situation, use of the pulmonary artery catheter,or PAC, is considered standard clinical care. It is not a research procedure. The PAC would be used even if you were not participating in this research project.
All research subjects will be evaluated at the time they are admitted to the ICU, 24 to 48 hours after admission to the ICU, and 7 days after leaving the ICU. At all three time points, we will be taking pictures of the heart using the two dimensional and three dimensional echocardiogram.
Additionally, at each time-point, we will collect a blood sample of approximately two and a half tablespoons each time, and a urine sample. We will be testing the sample for biomarkers of heart failure which are proteins and enzymes specifically related to heart function. We will not be conducting any genetic research on the sample. Any extra blood from these research tests will not be saved for future research.
We will also be looking at the data that is collected by the pulmonary artery catheter. The catheter has a sensor on it that measures things like blood flow and pressure in the heart.
At the Day 7 post discharge visit there will be a six minute hall walk so that we can access the distance that you can walk. We will access any symptoms that you may experience. A nurse or physician will monitor the six minute hall walk.
The research information that we collect on you will not be placed in your medical record. The data is for research purposes only.
详细描述
Study Design This is a single-center, prospective cohort study. The project will be carried out at the Main Campus of the Cleveland Clinic Foundation. Comprehensive transthoracic echocardiography will be performed in the Heart Failure Intensive Care Unit at the Cleveland Clinic Foundation. This is an eight bed intensive care unit dedicated to treating patients with acute clinical issues related to heart failure and is staffed by heart failure specialists, medical officers and nurses specializing in heart failure management.
Therapy will be individualized per patient and will be entirely at the discretion of the patients' cardiologist under the standard of care. Nevertheless, the Heart Failure Intensive Care Unit has standard drug protocols for intravenous vasodilators such as nitroglycerin and sodium nitroprusside, as well as inotropic therapy such as dobutamine and or milrinone, and pressors such as norepinephrine and or vasopressin. Based on the hemodynamic assessment using PAC, diuretics and vasodilators will be the first-line agents, followed by inotropic agents. Oral vasodilators will be instituted following a standard protocol. All medications and their doses will be noted at the time of each echocardiographic evaluation.
The schedule will be as follows:
- The first echo will be performed within 24 hours of PAC insertion. Preferably at the time of or prior to commencing treatment in the Heart Failure Intensive Care unit.
- The second echo will be performed 24-72 hours after baseline echo in the Heart Failure Intensive Care unit.
- The third echo will be performed at the time of the scheduled outpatient visit after hospital discharge. The tests will be performed in the General Clinical Research Center which is an outpatient visit located on the fifth floor of the M building or at Cardiology Desk F-17.
Timeline for individual patients:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admission to H-22 with Acute Decompensated Heart Failure
- •clinical indication for PAC placement
排除标准
- •pericardial constriction or tamponage on echo or by other imaging modality
- •status post cardiac transplantation
- •inability to provide informed consent or unable or unwilling to follow protocol
结局指标
主要结局
Surrogate marker of hemodynamic responses to therapy.
时间窗: Admission to ICU - 2 weeks post discharge
Correlation of peak systolic right ventricular strain with PCWP
次要结局
未报告次要终点