Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure (TARVA)
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Cardiovascular Diseases |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
H22 ICU
8-bed intensive care unit dedicated to treating patients with acute clinical issues related to heart failure
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
patients admitted to H22 ICU
Inclusion Criteria:
- admission to H-22 with Acute Decompensated Heart Failure
- clinical indication for PAC placement
Exclusion Criteria:
- 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
Contacts and Locations| Contact: James Thomas, MD | 1-800-223-2273 ext 56312 | thomasj@ccf.org |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Christine Whitman, RN 216-445-6916 whitmac@ccf.org | |
| Contact: Allan Borowski 1-800-223-2273 ext 55243 borowsa@ccf.org | |
| Principal Investigator: Jim Thomas, MD | |
| Principal Investigator: | James Thomas, MD | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | Jim Thomas, MD, Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT00589758 History of Changes |
| Other Study ID Numbers: | TARVA, IRB 06-467 |
| Study First Received: | December 27, 2007 |
| Last Updated: | June 10, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by The Cleveland Clinic:
|
Right Ventricle Echocardiogram Evaluation of Heart Failure |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013