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Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure (TARVA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00589758
First received: December 27, 2007
Last updated: January 31, 2017
Last verified: January 2017
  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 Intervention
Cardiovascular Diseases
Diagnostic Test: Echocardiography
Other: Biomarker evaluation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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

Enrollment: 75
Actual Study Start Date: July 2006
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients admitted to H22 ICU
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589758

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

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00589758     History of Changes
Other Study ID Numbers: 06-467
Study First Received: December 27, 2007
Last Updated: January 31, 2017
Individual Participant Data  
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
Echocardiogram
Evaluation of Heart Failure

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 28, 2017