Resynchronization Therapy in Young Patients With and Without CHD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Margaret Strieper, Emory University
ClinicalTrials.gov Identifier:
NCT00208806
First received: September 13, 2005
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Pacemakers can be attached to one or more than one of the heart chambers. After watching pacemakers work over time, doctors have found that the pacemakers that stimulate only one chamber of the heart sometimes lead to problems later. These problems may be changes in the size and shape of the heart. The heart cannot work as well when some of these changes happen. We need to learn more about these changes and how to prevent them. There has not been an easy way to do this. A new treatment called Cardiac Resynchronization Therapy (CRT) is associated with biventricular pacing where two chambers of the heart are stimulated simultaneously. Tissue Doppler Imaging,Tissue Synchronization Imaging and 3 dimensional echocardiography are new forms of technology that look at the heart while it works. They are similar to a moving x-ray that can watch the heart muscles moving. The movement can be measured. Doctors will check for changes that happen over time. This has not been studied in children before because this kind of is new to this group of patients. This technology is noninvasive which means it can be done from the outside of the body and is painless.

The hearts of children grow fast. It is important to be able to know if the pacemaker or problems from dilated cardiomyopathy are causing any changes in the heart that might cause problems. We expect to be able to use information we learn from this study to improve how we use pacemakers in the future to avoid problems that can happen over time.


Condition Intervention
Dilated Cardiomyopathy
Pediatric
Other: congestive heart failure patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of Dilated Cardiomyopathy and Cardiac Resynchronization Therapy for Ventricular Dysfunction in Young Patients With and Without Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Emory University:

Estimated Enrollment: 50
Study Start Date: June 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
congenital heart patients with congestive heart failure
20 effected patients with congestive heart failure patients total 50 patients
Other: congestive heart failure patients
observational echo data on congestive heart failure patients

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with dilated cardiomyopathy
  • normal heart anatomy or those with repaired congenital defects that have a 4 chambered heart
  • referred for a Biventricular pacemaker implantation or upgrade with the diagnosis of dilated cardiomyopathy or for an echocardiogram due to the diagnosis of dilated cardiomyopathy without pacemaker
  • signed informed consent

Exclusion Criteria:

  • cannot travel back to Children's Healthcare of Atlanta for follow-up
  • Patients with a transplanted heart
  • no informed consent
  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: NCT00208806

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Margaret Strieper, DO Emory University and Children's Healthcare of Atlanta
  More Information

Publications:
Responsible Party: Margaret Strieper, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00208806     History of Changes
Other Study ID Numbers: 0418-2004
Study First Received: September 13, 2005
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Dilated Cardiomyopathy
Pediatric
Bi-ventricular Pacemaker

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Ventricular Dysfunction
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014