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. Identifier: NCT00589758
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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
Blood and Urine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00589758

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: James Thomas, MD The Cleveland Clinic

Responsible Party: The Cleveland Clinic Identifier: NCT00589758     History of Changes
Other Study ID Numbers: 06-467
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Cleveland Clinic:
Right Ventricle
Evaluation of Heart Failure

Additional relevant MeSH terms:
Cardiovascular Diseases