Tissue Doppler Echo Imaging of Heart Function After Transplant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00208650
First received: September 13, 2005
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

There are many children born with Congenital Heart Disease. Many of these children have to undergo surgical procedures to correct the problem. Some patients must eventually get a new heart. Once they get a new heart, we have to have ways to determine how well the new heart is doing inside of the body. Tissue Doppler Imaging is one way of doing so. Tissue Doppler Imaging is like an ultrasounds. It takes pictures of the heart. In addition to Tissue Doppler Imaging, there is a newer non-invasive procedure called Tissue Synchronization Imaging which will allow us to see how well the new heart is working as well. In this study we would use both techniques to determine how well the new heart is working.


Condition
Children With Heart Transplants

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-Invasive Quantitation of Myocardial Dysfunction by Tissue Doppler/Synchronization Imaging After Orthotopic Heart Transplantation in Children

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 75
Study Start Date: September 2005
Study Completion Date: September 2006
Detailed Description:

Heart transplantation is the only hope for children with end stage heart disease. Eventually cardiac deterioration occurs and leads to death or re-transplantation. Our understanding of the pathophysiology of cardiac dysfunction in these children is incomplete. The time course of the dysfunction process either in the RV and/or the LV, systole or diastole has never been studied in children. No meaningful TSI quantitation has ever been performed in a large pediatric OHT patient population. The long-term goal of this study will be the detection of functional myocardial changes associated with known stages post heart transplantation using TDI and TSI. These achievements impact the survival and quality of life of children after cardiac transplantation.

Research Design and Methods

All subjects who are treated in the transplant clinic will be approached for possible participation into the study. These patients will include newly transplanted (OHT) patients as well as patients who underwent OHT prior to the enrollment year. The following procedures will occur at each study visit:

Echocardiographic assessment Standard 2-dimensional, M-mode, and Doppler or 3-dimensional echocardiography evaluation will be performed. We will assess cardiac function using left ventricular shortening (SF) and ejection fractions (EF). The EF will be calculated using both M-Mode and by Simpson's rule. We will also perform tissue synchronization imaging (TSI) and tissue Doppler imaging (TDI) using the GE Vivid 7 echocardiographic system. Both TSI and TDI will assist investigators in assessing mechanical synchrony. In newly transplanted patients, these echocardiographic assessments will occur during the first 5 days to serially measure ventricular synchrony during the acute post-operative period. For older transplant patients and for new transplant patients greater than five days out from transplantation, echocardiographic studies will occur at all follow-up clinic visits as determined by physician preference.

Clinical assessment Clinical evaluation will be performed during all follow-up visits in order to track unrecognized complications or adverse events. As is standard, all patients undergoing transplantation follow-up will have an electrocardiogram (EKG) performed to assess rhythm.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Children who have had cardiac transplant within one year.

Exclusion Criteria:

-

  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: NCT00208650

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Derek Fyfe, MD Emory University
  More Information

Publications:
Responsible Party: William T. Mahle, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00208650     History of Changes
Other Study ID Numbers: 0620-2004
Study First Received: September 13, 2005
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
pediatrics
transplant
cardiac

ClinicalTrials.gov processed this record on July 28, 2014