Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure

Completed

Conditions studied: Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT00589758

Run by

The Cleveland Clinic

People needed

75

Starts

2006-07-01

Expected to finish

2014-06-01

Last updated by the study team

2017-02-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• admission to H-22 with Acute Decompensated Heart Failure
• clinical indication for PAC placement

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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