Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure (TARVA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00589758|
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : February 1, 2017
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.
|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases||Diagnostic Test: Echocardiography Other: Biomarker evaluation|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||75 participants|
|Official Title:||Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure|
|Actual Study Start Date :||July 2006|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||June 2014|
Acute Decompensated Heart Failure
Admitted to Heart Failure ICU for acute decompensated heart failure. 2D and 3D echocardiography will be obtained at baseline, 24 -48 hours and 1-2 weeks post discharge.
Blood and urine will be collected for biomarker evaluation at each timepoint
Diagnostic Test: Echocardiography
2D and 3D echocardiography
Other: Biomarker evaluation
Blood and urine collected
- Surrogate marker of hemodynamic responses to therapy. [ Time Frame: Admission to ICU - 2 weeks post discharge ]Correlation of peak systolic right ventricular strain with PCWP
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589758
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||James Thomas, MD||The Cleveland Clinic|