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Exercise in Chronically Paced Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374608
First Posted: September 11, 2006
Last Update Posted: June 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Patricio A. Frias, MD, Emory University
  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 Patricio A. Frias, MD, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Ijiri H, Komori S, Kohno I, Sano S, Yin D, Takusagawa M, Iida T, Yamamoto K, Osada M, Sawanobori T, Ishihara T, Umetani K, Tamura K. Improvement of exercise tolerance by single lead VDD pacemaker: evaluation using cardiopulmonary exercise test. Pacing Clin Electrophysiol. 2000 Sep;23(9):1336-42.
Sulke N, Dritsas A, Bostock J, Wells A, Morris R, Sowton E. "Subclinical" pacemaker syndrome: a randomised study of symptom free patients with ventricular demand (VVI) pacemakers upgraded to dual chamber devices. Br Heart J. 1992 Jan;67(1):57-64.
Lee MA, Dae MW, Langberg JJ, Griffin JC, Chin MC, Finkbeiner WE, O'Connell JW, Botvinick E, Scheinman MM, Rosenqvist M. Effects of long-term right ventricular apical pacing on left ventricular perfusion, innervation, function and histology. J Am Coll Cardiol. 1994 Jul;24(1):225-32.
Bax JJ, Ansalone G, Breithardt OA, Derumeaux G, Leclercq C, Schalij MJ, Sogaard P, St John Sutton M, Nihoyannopoulos P. Echocardiographic evaluation of cardiac resynchronization therapy: ready for routine clinical use? A critical appraisal. J Am Coll Cardiol. 2004 Jul 7;44(1):1-9. Review.
Saxon LA, De Marco T, Schafer J, Chatterjee K, Kumar UN, Foster E; VIGOR Congestive Heart Failure Investigators. Effects of long-term biventricular stimulation for resynchronization on echocardiographic measures of remodeling. Circulation. 2002 Mar 19;105(11):1304-10.
Waggoner AD, Bierig SM. Tissue Doppler imaging: a useful echocardiographic method for the cardiac sonographer to assess systolic and diastolic ventricular function. J Am Soc Echocardiogr. 2001 Dec;14(12):1143-52. Review.
Wonisch M, Lercher P, Scherr D, Maier R, Pokan R, Hofmann P, von Duvillard SP. Influence of permanent right ventricular pacing on cardiorespiratory exercise parameters in chronic heart failure patients with implanted cardioverter defibrillators. Chest. 2005 Mar;127(3):787-93.
Thambo JB, Bordachar P, Garrigue S, Lafitte S, Sanders P, Reuter S, Girardot R, Crepin D, Reant P, Roudaut R, Jaïs P, Haïssaguerre M, Clementy J, Jimenez M. Detrimental ventricular remodeling in patients with congenital complete heart block and chronic right ventricular apical pacing. Circulation. 2004 Dec 21;110(25):3766-72. Epub 2004 Dec 6.
Yu CM, Lin H, Fung WH, Zhang Q, Kong SL, Sanderson JE. Comparison of acute changes in left ventricular volume, systolic and diastolic functions, and intraventricular synchronicity after biventricular and right ventricular pacing for heart failure. Am Heart J. 2003 May;145(5):E18.
Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC; Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001 Mar 22;344(12):873-80.

Responsible Party: Patricio A. Frias, MD, Associate Professor, Pediatrics, Emory University
ClinicalTrials.gov Identifier: NCT00374608     History of Changes
Other Study ID Numbers: 291-2006
First Submitted: September 8, 2006
First Posted: September 11, 2006
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by Patricio A. Frias, MD, Emory University:
pediatric
congenital complete heart block
dual chamber pacemaker

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


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