Exercise in Chronically Paced Children

This study has been completed.
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Patricio A. Frias, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00374608
First received: September 8, 2006
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to evaluate the exercise capacity of patients with complete heart block who are chronically being paced from the right ventricle. Also, we hope to correlate the level of uncoordinated contraction with the patients exercise capacity. We will enroll patients with complete heart block as diagnosed by standard electrocardiographic means and now have a permanent pacemaker. All patients we approach for this study will receive an echocardiogram to assess their heart function. As part of the echocardiogram, they will also receive a Tissue Synchronization Imaging (TSI) evaluation to assess the level of uncoordinated contraction they have. The patients will then be subjected to a cardiac exercise stress test which will involve them running on a treadmill until they cannot continue while data is collected regarding their heart's response to exercise. All portions of the study are noninvasive, which means they work from probes and monitors outside the body.


Condition
Congenital Diseases
Complete Heart Block
Pacemaker

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Single Center, Prospective, Pilot Study Examining the Evaluation of Exercise Capacity in Chronically RV Paced Children and Young Adults

Resource links provided by NLM:


Further study details as provided by Emory University:

Enrollment: 25
Study Start Date: January 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pt who have congenital complete heart block with no other preexisting condition that precludes the patient from exercise

Criteria

Inclusion Criteria:

  • between 10 and 21 years of age
  • structurally normal heart
  • congenital complete heart block
  • dual chamber pacemaker, right ventricular apex paced
  • normal function via traditional transthoracic echocardiography

Exclusion Criteria:

  • preexisting condition that precludes patient from exercise
  • 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: NCT00374608

Locations
United States, Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Patricio A Frias, MD Emory University and Children's Healthcare of Atlanta
  More Information

Publications:

Responsible Party: Patricio A. Frias, MD, Associate Professor, Pediatrics, Emory University
ClinicalTrials.gov Identifier: NCT00374608     History of Changes
Other Study ID Numbers: 291-2006
Study First Received: September 8, 2006
Last Updated: May 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
pediatric
congenital complete heart block
dual chamber pacemaker

Additional relevant MeSH terms:
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014