Exercise in Chronically Paced Children - Full Text View

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:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

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

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:

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, Jais P, Haissaguerre 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
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 May 23, 2013