Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure

NCT00589758 | Completed

• 1 other identifier: 06-467
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Right Ventricle; Echocardiogram; Evaluation of Heart Failure

Outcome Measures

Primary Outcomes (1)

• Surrogate marker of hemodynamic responses to therapy.

  Correlation of peak systolic right ventricular strain with PCWP

  Admission to ICU - 2 weeks post discharge

Study Arms (1)

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; Other: Biomarker evaluation

Interventions

Echocardiography DIAGNOSTIC_TEST

2D and 3D echocardiography

Acute Decompensated Heart Failure

Biomarker evaluation OTHER

Blood and urine collected

Acute Decompensated Heart Failure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients admitted to H22 ICU

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and Urine

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• James Thomas, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 10, 2008
• Study Start: July 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)